[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oropharyngeal-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oropharyngeal-squamous-cell-carcinoma":33},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,30,0,25,[9,62,75,102,132,192,219,243,281,309,331,351,385,413,437,478,500,526,546,566,589,610,647,667,698],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":41,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":61},"100054087","phase-1-docetaxel-and-sx-682-in-recurrentmetastatic-head-and-neck-squamous-cell-carcinoma-salivary-gland-carcinoma-and-advanced-prostate-cancer-100054087",false,"NCT07667400","Docetaxel and SX-682 in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer","Phase I\u002FII Trial of Docetaxel and SX-682 in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer","* INCLUSION CRITERIA:\n\nAll Participants\n\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \\\u003C= 2\n* Participants must have adequate organ and marrow function as defined below:\n\n  * ANC \\>= 1,500\u002FmcL\n  * Hemoglobin (Hgb) \\>= 9 g\u002FdL\n  * Platelets (PLTs) \\>= 100,000\u002FmcL\n  * Creatinine clearance \\>= 50 mL\u002Fmin (by Cockroft-Gault formula)\n  * Total bilirubin \\\u003C= 1.5 x iULN (\\\u003C= 3 x ULN in participants with known\u002Fsuspected Gilbert s disease)\n  * ALT\u002FAST \\\u003C= 2.5 x iULN\n  * Activated partial thromboplastin time (aPTT) \\\u003C= 1.5 x iULN\n* Contraception as follows:\n* Women of child-bearing potential (WOCBP) must agree to use an effective method of contraception (barrier, hormonal, intrauterine device \\[IUD\\], surgical sterilization, abstinence) prior to study entry, for the duration of study treatment, and for up to 2 months after discontinuation of the study drugs. A participant may request a male partner to use an effective form of contraception to fulfill this requirement.\n* Men able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 4 months after discontinuation of the study drugs. A participant may request a female partner to use an effective form of contraception to fulfill this requirement. Men able to father a child must not freeze or donate sperm within the same period.\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through one week after the last dose of study drugs.\n* Participants must be able to swallow oral medications.\n* Human immunodeficiency virus (HIV)-infected participants must have undetectable viral load (VL) and be on effective anti-retroviral therapy within 4 weeks prior to the study treatment initiation and have no history of opportunistic infections or Castleman s disease within 12 months prior to the study treatment initiation.\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV VL.\n* Participants with evidence of chronic hepatitis C virus (HCV) infection must have undetectable HCV VL.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nParticipants with HNC\n\n* Histologically confirmed HNSCC (including oral cavity, oropharynx, larynx, hypopharynx, paranasal sinuses, nasopharynx) or SGC (including ACC and non-ACC) and recurrent\u002Fmetastatic (R\u002FM) or advanced incurable disease.\n* Prior treatment as follows:\n\n  * Participants with R\u002FM HNSCC must have prior systemic treatment (platinum-based chemotherapy and\u002For anti-PD(L)1 treatment).\n  * Participants with R\u002FM SGC may have any number of prior systemic treatment lines; prior systemic treatment not required for participation.\n  * Participants must not have received systemic anticancer treatment within 3 weeks prior to first treatment administration. Note: Treatment-related toxicities must have resolved to Grade \\\u003C2 or be minimal and not constitute a safety risk. Participants with SGC previously treated with hormonal therapies (e.g., drugs targeting the androgen receptor) may continue these drugs concomitantly with study therapy. Participants with bone metastases or hypercalcemia on intravenous bisphosphonate medications, denosumab, or similar agents, are eligible to participate and may continue this treatment.\n* Presence of \\>= 1 measurable lesion by RECIST v 1.1 criteria.\n\nParticipants with mCRPC\n\n* Documented histopathological confirmation of prostate cancer. If no pathologic report or specimen is available, participants may enroll with a history of clinical course consistent with the disease.\n* Participants must have mCRPC, defined as at least one lesion on TC-99 bone scan or at least one lesion that is measurable per RECIST 1.1.\n* Participants must need ADT as part of their cancer therapy (unless previous orchiectomy)\n* Castrate testosterone level (\\\u003C50 ng\u002Fdl or 1.7 nmol\u002FL)\n* Prior treatment as follows:\n\n  * DTX for mCRPC is allowed but participants must not have had progression while on docetaxel or within 3 months after completing DTX for mCRPC\n  * Participants must have been previously treated with modern anti-androgens such as abiraterone, enzalutamide, apalutamide, or darolutamide.\n* Progression defined as two consecutive rising PSA values at least 1 week apart or radiographic evidence of progression seen on computed tomography (CT) scan or TC- 99 bone scan.\n* Toxicities related to prior therapy, including surgery and\u002For radiation, must have resolved to \\\u003C Grade 1 per CTCAE v.6.0.\n\nEXCLUSION CRITERIA:\n\nAll participants\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to DTX, SX-682, or other agents used in study (e.g., polysorbate 80).\n* Known active brain metastases. Note: Participants with previously treated brain metastases are eligible if imaging at least four weeks prior to first trial treatment shows no evidence of progression and neurologic symptoms have resolved, have no new or enlarging brain metastases, and are not using glucocorticoids for at least a week prior to first trial treatment\n* Participants must not have received other investigational agents within 3 weeks prior to the first dose of the study drug(s).\n* Participants must not have received major surgery within 14 days prior to the first drug administration (minimally invasive procedures such as diagnostic biopsies are permitted). If participant underwent major surgery, they must have recovered adequately (according to the Principal Investigator) from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n* Treatment (systemic) with any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A4) listed at https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-druginteractions- table-substrates-inhibitors-and-inducers#table2-2,table3-3,table5-2 within 2 weeks or 5 half-lives (whichever is shorter) prior to the start of the study treatment.\n* Prior or concurrent malignancy whose natural history or treatment has potential to interfere with the safety or efficacy assessment of the study treatment.\n* Participants with serious uncontrolled intercurrent illness evaluated by medical history, electrocardiogram (EKG), and physical exam that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study or that would limit compliance with study requirements.\n\nParticipants with HNC\n\n* Participants must not have received large-field radiotherapy within 2 weeks prior to first treatment administration. All residual treatment-related toxicities must have resolved to Grade \\\u003C2 (except for radiation-induced xerostomia\u002Fdysgeusia) or be minimal and not constitute a safety risk.\n* Positive pregnancy serum or urine beta-human chorionic gonadotropin (beta-hCG) test\n\nParticipants with mCRPC\n\n* Use of other medications for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g., phytoestrogens and saw palmetto) within 1 week prior to the study treatment initiation.\n* Cancer related neuropathy at screening\n* Baseline QTcF \\>= 470 ms","ALL","18 Years","120 Years",{"count":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","Background:\n\nHead and neck cancers (HNCs) account for about 5% of all cancers worldwide. They grow in the mouth, throat, nasal cavity, or salivary glands. Prostate cancer is the most common cancer in men in the United States. Survival rates for these cancers are lower than 50% if they spread to other parts of the body or return after treatment. Better treatments are needed.\n\nObjective:\n\nTo test a new drug (SX-682), combined with an approved drug (docetaxel, or DTX), in people with HNCs or prostate cancer.\n\nEligibility\n\nPeople aged 18 years and older with an HNC or prostate cancer that has returned after treatment or has spread.\n\nDesign:\n\nParticipants will be screened. They will have blood tests, imaging scans, and a test of their heart function. A tissue sample (biopsy) of the tumor may be taken.\n\nParticipants will take the study drugs in 3-week cycles. SX-682 is a tablet taken by mouth twice a day from Days 1 to 11 of each cycle. Participants will get a supply of the drug to take home. DTX is given on Day 8 of each cycle through a tube attached to a needle inserted into a vein in the arm. Participants will come to the clinic on Days 1 and 8 of every cycle. They will take both drugs for up to 6 cycles.\n\nParticipants will have follow-up visits 1 week and 1 month after they finish taking the drugs. Follow-ups will continue every 3 months for 2 years. Then they will have phone or email check-ins twice a year until 5 years have passed.",[29,30,31,32,33,34,35,36,37,38,39,40],"Head and Neck Cancer","Head and Neck Squamous Cell Carcinoma","Paranasal Sinus Neoplasms","Nasopharyngeal Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Hypopharyngeal Cancer","Carcinoma of Larynx","Oral Squamous Cell Carcinoma","Salivary Gland Cancer","Adenoid Cystic Carcinoma","Prostate Cancer","Metastatic Castration Resistant Prostate Cancer",[42,43,44,45,46,47,48],"Solid Tumors","Infusion","Chemotherapy","Carcinoma","Head and Neck","Prostate","molecule inhibitor","NOT_YET_RECRUITING","2026-07-10",{"date":52,"type":53},"2026-07-13","ACTUAL",{"date":55,"type":22},"2026-07-16",{"date":57,"type":22},"2037-10-01",{"name":59,"class":60},"National Cancer Institute (NCI)","NIH",1,{"id":63,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":27,"conditions":66,"keywords":67,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":74,"locationsCount":61},"100643883",{"count":21,"type":22},[25,26],[29,30,31,32,33,34,35,36,37,38,39,40],[42,43,44,45,46,47,48],"2026-07-01",{"date":70,"type":53},"2026-07-02",{"date":72,"type":22},"2026-07-07",{"date":57,"type":22},{"name":59,"class":60},{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":17,"minAge":81,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100479430","the-registry-study-of-genetic-alterations-of-oropharyngeal-cancer-in-taiwan-100479430","NCT05522881","The Registry Study of Genetic Alterations of Oropharyngeal Cancer in Taiwan","Inclusion Criteria:\n\n1. Ages 20 and above\n2. Pathological reported as squamous cell carcinoma of head and neck\n3. Available p16 immunohistochemical staining status (restricted to the OPSCC subgroup)\n4. Participants have both archival tumor tissues from the primary head and neck SCC and from the first recurrent tumor (for the recurrence subgroup)\n5. Recurrence status is defined as the reappearance of the disease occurring more than 6 months following curative surgery and\u002For chemoradiotherapy in the recurrence subgroup\n6. Willingness to provide archival or newly obtained tumor tissues for current study proposal\n7. Life expectancy more than 3 months\n8. Patients fully understand the protocol with the willingness to have regular follow-up\n\nExclusion criteria\n\n1. Inability to cooperate by providing a complete medical history\n2. No available tumor tissues for genetic testing\n3. Undesirable compliance\n4. Having a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., cervical carcinoma in situ) that have undergone potentially curative therapy are not excluded","20 Years",{"count":83,"type":22},410,"OBSERVATIONAL","We will use the next-generation sequencing (NGS) technology to identify genomic alterations of Taiwanese HPV positive and negative oropharyngeal squamous cell carcinoma (OPSCC) for novel biomarker development and the study design of potential clinical trials or translational research.",[33],[88,89,90,91],"human papillomavirus","oropharyngeal squamous cell carcinoma","next-generation sequencing","precision medicine","RECRUITING",{"date":70,"type":53},{"date":95,"type":53},"2022-11-25",{"date":97,"type":22},"2029-12",{"name":99,"class":100},"National Health Research Institutes, Taiwan","OTHER",7,{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":17,"minAge":109,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":114,"conditions":115,"keywords":121,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":61},"100644717","evaluating-the-optimal-timing-of-acupuncture-for-managing-chemoradiation-induced-xerostomia-in-patients-with-head-and-neck-cancers-100644717","NCT07674706","Evaluating the Optimal Timing of Acupuncture for Managing Chemoradiation-induced Xerostomia in Patients With Head and Neck Cancers","A Pilot Randomised Trial Evaluating the Optimal Timing of Acupuncture for Managing Chemoradiation-induced Xerostomia in Patients With Head and Neck Cancers","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all the following criteria apply:\n\n1. Aged 21 years or older\n2. Oral cavity or oropharyngeal squamous cell carcinoma, or nasopharyngeal carcinoma planned for either curative adjuvant or definitive chemoradiotherapy using intensity-modulated radiation therapy (IMRT).\n\n   Participants who have received prior induction chemotherapy or are planned for adjuvant chemotherapy are not excluded.\n3. Anatomically intact parotid and submandibular glands\n4. Eastern Cooperative Oncology Group performance status of 0 to 2\n5. Able to provide informed consent\n6. A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:\n\n   1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR\n   2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the acupuncture period and for at least 28 days after the last acupuncture.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. History of xerostomia, Sjögren's disease, or another underlying systemic illness known to cause xerostomia\n2. Prior head and neck radiation treatment\n3. Has bleeding disorders (e.g. Hemophilia), or on anticoagulants (e.g. warfarin, low molecular weight heparin and novel oral anticoagulants)\n4. Upper or lower extremity deformities that could interfere with accurate acupoint location or alter the energy pathway as defined by traditional acupuncture theory.\n5. Local skin infections, lymphedema, or severe skin conditions (e.g., psoriasis, eczema) at or near the acupuncture sites\n6. Ongoing active systemic infection\n7. Current use of amifostine or cholinergic agonist medications (pilocarpine, cevimeline) that can affect salivary functions (salivary substitute not prohibited, but if using, they must refrain from using it for at least 24 hours prior to salivary flow assessment)\n8. Concurrent use of alternative medicines (e.g., Chinese Propriety medicines), that could affect salivary function\n9. Is pregnant or expecting to conceive within the projected duration of the trial, starting with the screening visit through 28 days after the last acupuncture treatment\n10. Low body mass index, ie. BMI \\\u003C 15\n11. Mental incapacitation or significant emotional or psychiatric disorder that, in the opinion of the investigator, may prevent the patient from cooperating with trial procedures","21 Years",{"count":111,"type":22},50,[113],"NA","While existing data supports the use of acupuncture to reduce radiation-induced xerostomia, the optimal timing of acupuncture for managing chemoradiation-induced xerostomia remains an area of active investigation. Prior studies have administered acupuncture either in patients who developed xerostomia 12 months after radiation 10 or during the radiation therapy itself 9. The hypothesis is that acupuncture may be more effective in preventing and reducing xerostomia when administered early during CRT, rather than after chronic xerostomia has already set in. Yet, oncologists have concerns about the potentially higher risk of complications, such as infection, associated with acupuncture, especially if administered concurrently with chemoradiotherapy. Therefore, this study aims to conduct this randomised trial to evaluate the impact of early versus delayed acupuncture on patient-reported and objective measures of xerostomia, as well as the safety and tolerability of acupuncture in this setting.\n\nTo our knowledge, this will be the first randomised clinical trial evaluating the optimal timing for incorporating acupuncture to reduce xerostomia in patients undergoing chemoradiation for head and neck cancers. It is also the first study conducted in Singapore to study the role of acupuncture in reducing CRT-induced xerostomia.",[116,117,118,119,120,33],"Xerostomia","Head Cancer","Neck Cancer","Nasopharyngeal Carcinoma (NPC)","Oral Cavity Squamous Cell Carcinoma",[122],"Acupuncture","2026-06-24",{"date":125,"type":53},"2026-06-29",{"date":127,"type":22},"2026-06",{"date":129,"type":22},"2029-06",{"name":131,"class":100},"National University Hospital, Singapore",{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":191},"100556989","phase-2-testing-the-addition-of-the-drug-bmx-001-a-radioprotector-or-a-placebo-to-the-usual-chemoradiation-therapy-for-patients-with-head-and-neck-cancer-100556989","NCT06532279","Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer","A Randomized, Masked, Placebo Controlled, Phase II Trial Of Concurrent Chemoradiation With BMX-001 In Patients With Head And Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation","Inclusion Criteria:\n\n* Patients must be planned to receive radiation and concurrent cisplatin chemotherapy as definitive therapy. Patients planned to receive concurrent cisplatin and radiation therapy in the adjuvant setting are not eligible.\n* At least two subsites (buccal mucosa, lips, retromolar trigone, floor of mouth, oral tongue, tonsil, soft palate, or hard palate) must have at least 1cc or 1% of the subsite volume receiving \\>= 50 Gy. In cases of uncertainty, the enrolling clinician can ensure coverage by inspecting the 50 Gy isodose line and using the table describing the anatomic boundaries of the individual subsites contained within the extended cavity contour. The two or more subsites receiving \\>= 50 Gy must be documented by the enrolling physician.\n* Pathologically confirmed (histologically or cytologically) squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity.\n* P16 and\u002For human papillomavirus (HPV) status (via polymerase chain reaction \\[PCR\\] or in situ hybridization \\[ISH\\]) must be documented for patients with oropharynx cancer.\n* No patients with T0\u002FTx\u002Funknown primary disease.\n* No definitive clinical or radiologic evidence of metastatic (M1) disease related to current diagnosis.\n* Able to receive intensity-modulated radiation therapy (IMRT) delivered as daily fractions of 2.0 Gy once per weekday with a cumulative radiation dose of 70 Gy.\n* Age \\>= 18.\n* Zubrod performance status of 0-2.\n* Potassium ≥ institutional lower limit of normal (LLN) and magnesium ≥ institutional LLN. Oral or intravenous (IV) replacement therapy of potassium or magnesium is permitted if parameters can be met after repletion.\n* Absolute neutrophil count (ANC) \\>= 1,500 cells\u002Fmm\\^3.\n* Platelets \\>= 100,000 cells\u002Fmm\\^3.\n* Hemoglobin \\>= 9.0 g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] \\>= 10.0 g\u002Fdl is acceptable).\n* Adequate renal function defined as creatinine clearance (CrCL) \\> 50 mL\u002Fmin by the Cockcroft-Gault formula.\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN) (not applicable to patients with known Gilbert's syndrome).\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 x institutional ULN.\n* No prior radiotherapy that would result in overlap of radiation treatment fields with planned treatment for study cancer, e.g., breast cancer with irradiation of the supraclavicular fossa\u002Flevel 4 neck.\n* No concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure.\n* No prior history of gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed.\n* No current treatment of adjuvant post-operative (op) chemoradiation.\n* No systemic treatment with inducers or strong inhibitors of cytochrome P450 =\\\u003C 4 days before registration. Note: Patients undergoing steroid treatment as a component of the anti-emetic regimen for cisplatin are eligible for the study. Treatment with the antifungal medications, nystatin, fluconazole , miconazole and clotrimazole are allowed.\n* No prior induction chemotherapy treatment.\n* No prior unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell skin carcinoma, resected T1-2N0M0 differentiated thyroid cancers, Ta bladder cancers, or low risk prostate cancer.\n* No clinically significant hearing impairment that precludes cisplatin, as per physician assessment.\n* No serious cardiovascular disease or cerebrovascular disease in the last 6 months prior to study enrollment; defined as a cerebrovascular accident, myocardial infarction, unstable angina, serious cardiac arrhythmia uncontrolled by medication or with the potential to interfere with protocol treatment, or current New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), or admission within last 6 months for CHF exacerbation; (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification).\n* No valvular heart disease.\n* No significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to enrollment.\n* No history or evidence upon physical\u002Fneurological examination of central nervous system disease (e.g., seizures) unrelated to cancer unless adequately controlled by medication.\n* No acute bacterial, viral, or fungal infection requiring intravenous antimicrobials within 7 days of enrollment.\n* No history of chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration.\n* No known personal or family history of long QT Syndrome; no marked baseline prolongation of QT\u002Fcorrected QT (QTc) interval (i.e., ≥ 2 electrocardiograms \\[EKGs\\] in prior 3 months of a QTc interval \\> 450 milliseconds (ms) for males and \\> 470 ms for females using the specific\u002Fusual choice by clinical center for correction factor.\n* Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities must be reversible to ≤ grade 1 with supplementation.\n* No poorly controlled hypertension (systolic blood pressure \\[SBP\\] \\> 160 and\u002For diastolic blood pressure \\[DBP\\] \\> 95) over 2 repeated measures within 30 days prior to registration.\n* No grade \\>= 2 oral mucositis per CTCAE version 5.0.\n* No grade \\>= 2 hypotension per CTCAE v. 5.0.\n* No medical necessity for anti-arrhythmics with significant risk of QTc prolongation such as class I and class III anti-arrhythmics. These include but are not limited to amiodarone, quinidine, dofetilide, sotalol, flecainide, and lidocaine.\n* No medical necessity for medications listed as prohibited.\n\n  * For standard management of oral mucositis, clinicians may consult the Multinational Association of Supportive Care in Cancer\u002FInternational Society of Oral Oncology (MASCC\u002FISOO) Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy. The only intervention against mucositis that is supported by level I evidence is low-level laser therapy (LLLT). Honey is rated at level II and benzydamine, which isn't available in the United States (US), is rated at level III. There are no other positively rated interventions.\n  * LLLT is prohibited in this study as its availability remains limited, it is not Food and Drug Administration (FDA) approved in the US, and it is considered investigational in many circumstances requiring enrollment in a dedicated protocol who requirements could conflict with this one. Therefore, institutions that use LLLT should only enroll patients who would not be eligible for (or do not want) that intervention. Honey is not on the list of prohibited medications for this study. Given the MASCC recommendation, benzydamine is allowed, although there is lack of availability in the United States of America (USA). The other listed prohibited medications are not recommended by MASCC and some are potentially harmful, such as glutamine, which is associated with mortality in patients receiving stem cell transplant.\n* No history of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).\n* Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.",{"count":140,"type":22},98,[26],"This phase II trial compares the effectiveness of adding BMX-001 to usual symptom management versus usual symptom management alone for reducing oral mucositis in patients who are receiving chemoradiation for head and neck cancer. Oral mucositis (inflammation and mouth sores) is a common side effect of chemoradiation that can cause pain and difficulty swallowing. Usual management of these side effects typically consists of using mouth rinses and pain medications during treatment and for several weeks after completion of treatment. BMX-001 neutralizes harmful substances in the body, preventing damage to macromolecules such as DNA and minimizes free radical-related toxicity in normal tissues. Adding BMX-001 to usual symptom management may be more effective than usual symptom management alone at reducing oral mucositis in patients receiving chemoradiation for head and neck cancer.",[144,145,146,30,147,148,149,120,33,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181],"Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Hypopharyngeal Squamous Cell Carcinoma","Laryngeal Squamous Cell Carcinoma","Nasopharyngeal Squamous Cell Carcinoma","Stage 0 Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage 0 Hypopharyngeal Carcinoma AJCC v8","Stage 0 Nasopharyngeal Carcinoma AJCC v8","Stage 0 Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage I Hypopharyngeal Carcinoma AJCC v8","Stage I Laryngeal Cancer AJCC v8","Stage I Lip and Oral Cavity Cancer AJCC v8","Stage I Nasopharyngeal Carcinoma AJCC v8","Stage I Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage II Hypopharyngeal Carcinoma AJCC v8","Stage II Laryngeal Cancer AJCC v8","Stage II Lip and Oral Cavity Cancer AJCC v8","Stage II Nasopharyngeal Carcinoma AJCC v8","Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage III Hypopharyngeal Carcinoma AJCC v8","Stage III Laryngeal Cancer AJCC v8","Stage III Lip and Oral Cavity Cancer AJCC v8","Stage III Nasopharyngeal Carcinoma AJCC v8","Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVA Hypopharyngeal Carcinoma AJCC v8","Stage IVA Laryngeal Cancer AJCC v8","Stage IVA Lip and Oral Cavity Cancer AJCC v8","Stage IVA Nasopharyngeal Carcinoma AJCC v8","Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVB Hypopharyngeal Carcinoma AJCC v8","Stage IVB Laryngeal Cancer AJCC v8","Stage IVB Lip and Oral Cavity Cancer AJCC v8","Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stomatitis","2026-06-22",{"date":184,"type":53},"2026-06-25",{"date":186,"type":53},"2025-06-23",{"date":188,"type":22},"2027-01-01",{"name":190,"class":100},"NRG Oncology",153,{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":61},"100520384","people-living-with-hiv-oral-and-oropharyngeal-cancer-and-health-equity-100520384","NCT06055868","People Living With HIV, Oral and Oropharyngeal Cancer, and Health Equity","People Living With HIV (PLWH), Oral and Oropharyngeal Cancer, and Health Equity: A Qualitative Study","Inclusion Criteria:\n\n* Participants must be 18-years old or older.\n* Participants must be individuals living with HIV\n* Ability to speak and understand English\n* Identify as one or more racial\u002Fethnic minority groups or sexual and gender minority groups\n* All genders and members of all races and ethnic groups are eligible for this study.\n\nExclusion Criteria:\n\n* Younger than 18-years old.\n* Not living with HIV.\n* Not able to speak and understand English.\n* Not classified as one or more racial\u002Fethnic minority groups or sexual and gender minority groups.",{"count":200,"type":22},144,"This is an exploratory qualitative study among People Living With HIV (PLWH) of diverse racial\u002Fethnic and sexual and gender minority (SGM) identities to explore individual, interpersonal, and structural oral health equity factors that serve as barriers or facilitators of accessing oral health care, knowledge and perceptions of human papillomavirus (HPV) vaccination and Oral squamous cell carcinoma (OSCC) \u002FOropharyngeal squamous cell carcinoma (OPSCC), and to collect recommendations on how to increase access to oral health care and engage PLWH in OSCC\u002FOPSCC prevention.",[203,36,33],"HIV Infections",[205,206,207,208,209],"Health Equity","Focus Group","Sexual and Gender Minority","People living with HIV","HPV, human papillomavirus","2026-06-16",{"date":212,"type":53},"2026-06-18",{"date":214,"type":53},"2025-02-13",{"date":216,"type":22},"2029-11-30",{"name":218,"class":100},"University of California, San Francisco",{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":23,"phases":227,"briefSummary":228,"conditions":229,"keywords":231,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":238,"leadSponsor":240,"locationsCount":242},"100632410","phase-2-risk-adapted-therapy-in-hpv-positive-oropharyngeal-cancer-using-circulating-tumor-ct-hpv-dna-profiling-react-20-100632410","NCT07513324","Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0)","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed, stage I, II, or III, HPV-associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma, as defined by 2017 American Joint Committee on Cancer (AJCC), 8th edition staging. Participants with HPV-associated disease of unknown primary (cT0) are eligible.\n\n  * Participants who undergo upfront surgery are permitted to enroll if their post-operative pathology necessitates that they receive adjuvant therapy.\n  * Participants who undergo upfront induction chemotherapy with platinum-based therapy are eligible if they have less than a complete clinical or radiologic response to induction as judged by the treating investigator(s).\n  * Participants with locoregionally recurrent disease are eligible if they completed definitive or curative-intent treatment and meet criteria 3.1, 6e below.\n* HPV status should be confirmed on tissue biopsy or cytologic sample by any of the following: (a) IHC staining for p16 with ≥70% expression, and\u002For (b) DNA testing (PCR or ISH) for high-risk subtypes 16, 18, 31, 33, or 35.\n* Tumor tissue available for PD-L1 CPS testing.\n* Age 18 years or older at the time of informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n* Intermediate or high-risk HPV+ disease defined by any one of the following:\n\n  * TTMV-HPV DNA score \\>200 at baseline and failure to clear by \\>95% by week 4-5 of treatment\n  * undetectable or low (≤200) TTMV-HPV DNA at baseline prior to treatment with clinical or pathologic T3-4 or N2-3 disease\n  * known HPV subtypes 18, 31, 33, or 35 (but excluding cT1-2N0 participants)\n  * known N3 disease or fixed neck nodes as judged by the treating investigator(s)\n  * any stage disease with known detectable TTMV-HPV DNA 6 weeks or onward from completion of definitive or curative-intent therapy without clinical or radiographic disease and with no additional intervening therapy administered.\n* Participants should have adequate organ and marrow function to receive adjuvant immunotherapy as outlined below:\n\n  * Absolute neutrophil count (ANC) ≥1500\u002FµL\n  * Platelets \\> 100,000\u002FµL\n  * Hemoglobin ≥9.0g.\u002FdL or ≥5.6 mmol\u002FLa\n  * Creatinine OR Measured or calculated b creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\n  * Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN\n  * AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)\n  * International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n  * Ability to understand and the willingness to sign a written informed consent document.\n  * Participants or persons of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 72 hours prior to the start of therapy. Note: Contraception requirements should conform with CTFG guidelines. The pembrolizumab standard for use of highly effective contraceptive methods for POCBP is 120 days (5 half-lives) after the last dose. Abstaining from breastfeeding after study intervention is at least 5 half-lives or 120 days.\n\nExclusion Criteria:\n\n* Participants with AJCC 2017 8th edition stage IV (M1, metastatic) disease.\n* Pregnant or lactating women.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or another stimulatory or co-inhibitory T-cell receptor treatment.\n* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of pembrolizumab.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days of first pembrolizumab dosing.\n* Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. Participants with a history of allogeneic tissue\u002Fsolid organ transplant are excluded.\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has a known history of uncontrolled human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority. Well-controlled typically includes a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening and achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening.\n* Has a known history of hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions: include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, and low-risk prostate adenocarcinoma being managed with active surveillance. A history of another separate malignancy in remission without evidence of active disease is permitted if chance of recurrence is thought to be low (in discussion with the Sponsor-investigator).\n* ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.\n\na Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.\n\nb Creatinine clearance (CrCl) should be calculated per institutional standard.",{"count":226,"type":22},116,[26],"The purpose of this study is to assess risk for HPV driven oropharyngeal cancers by using HPV blood tests and clinical features (such as tumor stage and smoking status) to determine appropriate treatment to improve survival outcomes in participants with stage I, II, or III, HPV-associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma,.",[230,33],"HPV-positive Oropharyngeal Squamous Cell Carcinoma",[232,233],"HPV-positive oropharyngeal squamous cell carcinoma","Oropharyngeal squamous cell carcinoma","2026-06-08",{"date":236,"type":53},"2026-06-09",{"date":68,"type":22},{"date":239,"type":22},"2030-01-01",{"name":241,"class":100},"Dana-Farber Cancer Institute",2,{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":23,"phases":252,"briefSummary":253,"conditions":254,"keywords":256,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":4},"100639509","phase-2-phase-2-study-of-nai-hpv-vaccine-and-nab-paclitaxel-in-hpv-positive-oropharyngeal-cancer-followed-by-de-intensified-radiation-compared-with-standard-chemoradiation-100639509","NCT07628062","Phase 2 Study of NAI, HPV Vaccine, and Nab-Paclitaxel in HPV-Positive Oropharyngeal Cancer Followed by De-Intensified Radiation Compared With Standard Chemoradiation","Open-Label, Single-Arm Phase 2 Study Of Nogapendekin Alfa Inbakicept, PD-L1 T-HaNK, And Bevacizumab And Randomized Phase 2B Study Of Nogapendekin Alfa Inbakicept, Bevacizumab, And Tumor Treatment Fields With Or Without PD-L1 T-HaNK In Participants With Recurrent Or Progressive Glioblastoma","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Histologically confirmed squamous cell carcinoma of the oropharynx that is HPV-positive (p16 immunohistochemistry positive and\u002For HPV DNA positive). Patients with cervical lymph node metastases from an unknown primary can be included if p16-positive and likely OPSCC origin.\n5. Locally advanced, stage III\u002FIV HPV-associated OPSCC that is a candidate for definitive chemoradiation. Specifically, tumors classified as T3 or T4 and\u002For node-positive disease (N2 or N3), without distant metastases (M0). Patients with very low-risk disease (e.g. T1-T2 N0-1) are excluded, as these might be handled with less intensive standard therapy or surgery rather than this trial approach.\n6. No prior definitive treatment for the current OPSCC. Patients must be treatment-naïve with respect to chemotherapy, radiation, or investigational therapy for this cancer. Prior diagnostic biopsy is allowed, but no prior curative surgery or radiation to the head and neck.\n7. Participants should be suitable for organ-preserving therapy (i.e., radiation) with no immediate need for surgical resection (the trial is non-surgical upfront).\n8. Must be willing to accept the randomized treatment assignment after the safety lead-in. During the initial safety phase, all participants receive experimental therapy; once randomization begins, patients and investigators will not choose the arm - it will be assigned by the randomization schedule. Enrolled patients should have no clear contraindication to either arm's therapy (for instance, a patient who absolutely cannot receive cisplatin due to allergy or comorbidity might not be suitable, since cisplatin is required in both arms). The inclusion\u002Fexclusion criteria are structured to ensure a homogeneous population suitable for both the experimental approach and SOC chemoradiation.\n9. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.\n10. Agreement to practice effective contraception for female participants of child-bearing potential and non-sterile males. Per cisplatin prescribing information, female participants of child-bearing potential must agree to use effective contraception for up to 14 months and non-sterile male participants must agree to use a condom for up to 11 months after last dose of cisplatin. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), orals, injectables, 2 forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and hormonal therapy.\n\nExclusion Criteria:\n\n1. HPV-negative or Non-OPSCC: Tumors that are p16-negative or not in the oropharynx are excluded.\n2. Any evidence of distant metastases (M1 disease) excludes the patient, since the trial is for curative-intent local\u002Fregional therapy.\n3. Previous radiation in the head\u002Fneck region or prior chemotherapy\u002Fimmunotherapy for this cancer disqualifies the patient. We require a clean baseline to assess our regimen.\n4. Active autoimmune disease or immunosuppression. The experimental arm includes immunotherapy (IL-15 receptor agonist and IBRX-042 vaccine), patients with active serious autoimmune disorders or those requiring immunosuppressive medications (e.g. chronic steroids \\>10 mg prednisone daily) are excluded to avoid severe immune-related complications. Well-controlled or mild autoimmune conditions may be considered on a case-by-case basis if risk is low.\n5. Inadequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to baseline:\n\n   1. Absolute neutrophil count (ANC) \\\u003C 1,500 cells\u002FμL without granulocyte colony-stimulating factor support\n   2. Platelet count \\\u003C 100,000\u002FμL without transfusion\n   3. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) \\> 2.5 × ULN, with the following exception:\n\n      Participants with documented liver metastases: AST and\u002For ALT \\> 5 × ULN\n   4. Serum bilirubin ≤ 3 × ULN\n   5. Creatinine clearance ≤ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n   6. Serum albumin \\\u003C 3.0 g\u002FdL.\n6. Significant cardiovascular disease (such as New York Heart Association cardiac disease class II or greater), myocardial infarction within 3 months prior to baseline, unstable arrhythmias, or unstable angina.\n7. Severe infections at the time of enrollment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.\n8. History of human immunodeficiency virus (HIV) with current CD4+ T-cell count \\\u003C 350 cells\u002FμL and\u002For a detectable HIV viral load.\n9. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk for treatment complications.\n10. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.\n11. Participation in an investigational drug study or history of receiving any investigational treatment within 30 days prior to the start of treatment on this study.\n12. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.\n13. Pregnant and nursing women.",{"count":251,"type":22},70,[26],"This Phase 2a\u002F2 study evaluates the safety, tolerability, and efficacy of neoadjuvant and adjuvant NAI, hAd5-HPV vaccine (IBRX-042), and nab-paclitaxel in participants with locally advanced HPV-positive oropharyngeal squamous cell carcinoma (OPSCC). The study includes a Phase 2a safety lead-in followed by a randomized Phase 2 comparison of a de-intensified experimental chemoradiation approach versus standard-of-care chemoradiation.",[255,33,29],"HPV-Positive Oropharyngeal Squamous Cell Carcinoma",[257,258,259,260,261,262,263,264,265,266,267,268,269,270,30],"Locally Advanced HPV-Positive OPSCC","Human Papillomavirus-Associated Oropharyngeal Cancer","HPV-16","Squamous Cell Carcinoma of the Oropharynx","Chemoradiation","Cisplatin","Intensity-Modulated Radiation Therapy","De-Intensification Strategy","Neoadjuvant Therapy","Adjuvant Immunotherapy","hAd5 HPV Vaccine","ANKTIVA","Phase 2","NavDx","2026-06-01",{"date":273,"type":53},"2026-06-04",{"date":275,"type":22},"2026-07-22",{"date":277,"type":22},"2031-06-27",{"name":279,"class":280},"ImmunityBio, Inc.","INDUSTRY",{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":23,"phases":290,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":308},"100591408","phase-2-testing-whether-cemiplimab-regn2810-plus-cdx-1140-given-prior-to-surgery-are-better-than-cemiplimab-regn2810-alone-in-patients-with-stage-iii-iv-head-and-neck-cancer-100591408","NCT06980038","Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer","A Phase 2 Window of Opportunity Trial of Neoadjuvant Agonistic Anti-CD40 Antibody CDX-1140 and Cemiplimab (REGN2810) in AJCC Stage III-IV Head and Neck Cancer Patients Prior to Surgery","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed American Joint Committee on Cancer (AJCC) stage III-IV T0-4, N0-3b, M0 mucosal head and neck squamous cell carcinoma (HNSCC) (oral cavity, oropharynx, larynx, hypopharynx, and nasal cavity) that is appropriate for surgical resection. Both previously untreated (primary) and recurrent (salvage) settings will be eligible. Tumors must be accessible to biopsy in clinic (patients with laryngeal, hypopharyngeal, nasal cavity and base of tongue tumors will have endoscopic biopsies)\n* For patients with oropharyngeal cancer, only p16-negative (non-human papillomavirus \\[HPV\\] related) patients will be eligible\n* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) by chest x-ray or as ≥ 10 mm (≥ 1 cm) with CT scan, MRI, or calipers by clinical exam\n* Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of cemiplimab (REGN2810) alone or in combination with CDX-1140 in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Hemoglobin (Hb) ≥ 7 g\u002FdL (transfusion allowed to bring Hb to this level)\n* Absolute neutrophil count ≥ 1,000\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) \u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 × institutional ULN\n* Creatinine ≤ 1.5 × institutional ULN OR glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Based on its mechanism of action, cemiplimab (REGN2810) can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated that inhibition of the PD-1\u002FPD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Women of childbearing potential and men should use effective contraception during treatment with cemiplimab (REGN2810) and for 4 months after the last dose. The reproductive and developmental toxicity of CDX-1140 has not been evaluated. Women of childbearing potential and their partners who receive CDX-1140 must therefore take adequate contraceptive measures\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Active or documented history of autoimmune disease within 2 years before screening\n* Prior or planned allogeneic hematopoietic stem cell transplantation (HSCT)\n* History of organ transplant that requires use of immunosuppressive medications\n* Current or prior use of immunosuppressive medication within 14 days prior to the start of study drug administration. Immunosuppressants may interfere with study drug efficacy\n* Any previous treatment with a PD-1 or PD-L1 inhibitor, including cemiplimab (REGN2810). It is unclear how prior exposure to immunotherapy would impact future use of checkpoint inhibitors\n* Concurrent use of prednisone (10 mg or more)\n* Patients with new pulmonary infiltrates indicative of pneumonitis, history of (non-infectious) pneumonitis\u002Finterstitial lung disease, or current pneumonitis\u002Finterstitial lung disease, including grade 1 pneumonitis (i.e., asymptomatic, clinical or diagnostic observation only, intervention not indicated)\n* Another active malignancy for which the natural history or treatment has potential to interfere with the safety or efficacy assessment of the investigational regimen on this trial\n* Patients who have not recovered from AE due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents, such as concurrent chemotherapy, biologic, immunologic or hormonal therapy for cancer treatment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to CDX-1140 or cemiplimab (REGN2810)\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because of the increased risk of immune-mediated rejection of the developing fetus with cemiplimab (REGN2810). Because of the potential for serious adverse reactions in breastfed children, women should not breastfeed during treatment with cemiplimab (REGN2810) and for at least 4 months after the last dose. These risks may also apply to CDX-1140",{"count":289,"type":22},44,[26],"This phase II trial compares the effectiveness of cemiplimab with CDX-1140 to cemiplimab without CDX-1140 prior to surgery in treating patients with stage III-IV head and neck cancer. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. CDX-1140 is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving cemiplimab with CDX-1140 versus cemiplimab alone before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed for patients with stage III-IV head and neck cancer.",[30,147,148,293,120,33,294,295,296,297,298,299,168,169,170,171,300,173,174,175,178,179],"Nasal Cavity Squamous Cell Carcinoma","Recurrent Head and Neck Squamous Cell Carcinoma","Recurrent Hypopharyngeal Squamous Cell Carcinoma","Recurrent Laryngeal Squamous Cell Carcinoma","Recurrent Nasal Cavity Squamous Cell Carcinoma","Recurrent Oral Cavity Squamous Cell Carcinoma","Recurrent Oropharyngeal Squamous Cell Carcinoma","Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8","2026-05-29",{"date":271,"type":53},{"date":304,"type":53},"2026-05-27",{"date":306,"type":22},"2027-11-24",{"name":59,"class":60},6,{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":23,"phases":319,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":327,"leadSponsor":329,"locationsCount":61},"100631202","phase-2-reduced-elective-nodal-and-ctv-dose-for-hpv-oropharyngeal-squamous-cell-carcinoma-100631202","NCT07497607","Reduced Elective Nodal and CTV Dose for HPV+ Oropharyngeal Squamous Cell Carcinoma","Reduced Elective Nodal and CTV Dose for HPV+ Oropharyngeal Squamous Cell Carcinoma (REDUCE-30)","REDUCE-30","Inclusion Criteria:\n\n1. Patients must have histologically or cytologically confirmed history of squamous cell carcinoma of the oropharynx (OPSCC) planned for definitive chemoradiation.\n2. Squamous cell carcinoma of the oropharynx (OPSCC) must be confirmed to be p16 positive based on immunohistochemical staining.\n3. OPSCC must be clinical stage T1-4N1-3M0 or T3-T4N0M0 as per AJCC volume 8.\n4. Patients must have measurable disease based on PET\u002FCT imaging completed within 45 days +\u002F- 1 week from date of eligibility confirmation.\n5. Age ≥18 years.\n6. ECOG performance status ≤2.\n7. Patients must be deemed eligible for planned SOC cisplatin per treating investigators and\u002For treating medical oncologist.\n8. Women of child-bearing potential and men must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.\n9. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* 1\\. Patients with metastatic or recurrent disease.\n\n  2\\. Carcinoma of the neck of unknown primary site origin (T0 is ineligible even if p16 is positive).\n\n  3\\. Prior radiotherapy resulting in overlap of radiation therapy fields.\n\n  4\\. Patients who are pregnant, nursing or intended to conceive or father children during the course of the study.\n\n  5\\. Patients with active autoimmune or connective tissue disease that require systemic treatment in the opinion of the Investigator.\n\n  6\\. Patients who are receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the Investigator.\n\n  7\\. Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous or not preferable, in the opinion of the Investigator.",{"count":318,"type":22},31,[26],"This is a single-arm, phase II study that is designed to investigate nodal and primary tumor CTV dose de-escalation (30 Gy) in HPV positive oropharyngeal cancer.",[33,322],"HPV Positive Oropharyngeal Squamous Cell Carcinoma","2026-05-13",{"date":325,"type":53},"2026-05-18",{"date":323,"type":53},{"date":328,"type":22},"2036-05-13",{"name":330,"class":100},"Sara Medek",{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":339,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":61},"100427923","phase-2-three-schedules-of-cue-101-administered-before-surgery-or-definitive-chemoradiation-therapy-in-hla-a0201-positive-patients-with-locally-advanced-hpv16-positive-oropharyngeal-squamous-cell-carcinoma-100427923","NCT04852328","Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma","Non-Randomized Phase 2 Trial of Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of squamous-cell carcinoma of the oropharynx or of an upper (levels 2-3) neck mass without a known primary site, but is suspected to be oropharynx based on clinical factors.\n* Stage I-III (AJCC 8th Edition) \\[except clinical stages T1N0 and T2N0, which are excluded from enrollment\\].\n* A candidate for standard of care therapy (either surgery followed by adjuvant therapy OR def-CRT), based on treating physician decision.\n* HLA-A\\*0201 genotype as determined by genomic testing on blood sample performed at a CLIA-certified clinical or central laboratory.\n* Tumors must test positive for HPV16 by PCR (performed on tumor) or ISH (performed in tumor) and p16INK4A expression (\\>70% staining in tumor cells) by IHC performed at a CLIA-certified clinical or central laboratory.\n* Have archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion of sufficient size and quality for eligibility determination.\n* At least 18 years of age.\n* ECOG performance status ≤ 1.\n* Normal bone marrow and organ function as defined below:\n\n  * Platelets ≥ 100,000\u002Fmcl\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Absolute neutrophil count ≥ 1,500\u002Fmcl\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN\n  * Total bilirubin ≤ 1.5 x IULN, except patients with Gilbert's syndrome, who may enroll if the conjugated bilirubin (total and direct) is within normal limits\n  * Creatinine \\\u003C 1.5 mg\u002FdL, or calculated or measured creatinine clearance \\>30 mL\u002Fmin by Cockcroft-Gault\n  * Note: Screening laboratory tests may be repeated once within 7 days.\n* The effects of CUE-101 on the developing human fetus are unknown. For this reason and because novel Fc Fusion Protein agents are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 30 days after completion of the study.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* History of prior allogeneic bone marrow, stem-cell or solid organ transplantation\n* Distant metastases.\n* Treatment with radiation therapy or systemic anti-cancer therapy prior to the initiation of study drug administration.\n* Treatment with corticosteroids (\\>10 mg per day prednisone or equivalent) or other immune suppressive drugs within the 14 days prior to the initiation of study drug administration. Corticosteroids for topical, ophthalmic, inhaled, or nasal administration are allowed. Physiological replacement with hydrocortisone up to a maximum dose of 40 mg per day is allowed.\n* History of clinically significant cardiovascular disease including:\n\n  * Myocardial infarction or unstable angina within the 16 weeks prior to the initiation of study drug\n  * Clinically significant cardiac arrhythmias\n  * Uncontrolled hypertension: systolic blood pressure \\>180 mmHg, diastolic blood pressure \\>100 mmHg\n  * Deep vein thrombosis, pulmonary embolism, stroke, or transient ischemic attack within the 16 weeks prior to the initiation of study drug\n  * QTc prolongation \\> 480 msec\n  * Congestive heart failure (New York Heart Association class III- IV)\n  * Pericarditis\u002Fclinically significant pericardial effusion\n  * Myocarditis\n* Clinically significant pulmonary compromise (eg, requirement for supplemental oxygen).\n* Clinically significant gastrointestinal (GI) disorders including history of:\n\n  * GI perforation within 1 year prior to study drug administration;\n  * GI bleeding within 3 months prior to the initiation of study drug;\n  * Acute pancreatitis within 3 months prior to the initiation of study drug;\n  * Diverticulitis that is clinically significant in the opinion of the investigator based on the extent or severity of known disease and\u002For the occurrence of clinically significant disease flares within 4 weeks prior to the initiation of study drug administration; and\u002For\n  * Cirrhosis.\n* Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. Patients requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than 1 week prior to the initiation of study drug.\n* Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction. However, patients with treated hepatitis C in complete remission and off therapy for \\> 1 year are eligible.\n* Second primary invasive malignancy that has not been in remission for greater than 2 years. Exceptions include: non-melanoma skin cancer; cervical carcinoma in situ; squamous intraepithelial lesion on Pap smear; localized prostate cancer (Gleason score \\\u003C 6); resected melanoma in situ; or favourable prognosis (\\\u003C10% relapse risk) thyroid cancer.\n* Prior treatment of the head and neck region with radiation therapy.\n* History of major surgery within 4 weeks prior to the initiation of study drug administration. A diagnostic needle or excisional biopsy is not considered major surgery.\n* Any serious underlying medical condition that would impair the ability of the patient to receive or tolerate the planned treatment at the investigational site.\n* Known hypersensitivity to recombinant proteins, polysorbate 80 or any excipient contained in the drug formulation for CUE-101.\n* Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed. Vaccination for COVID-19 is allowed within one week prior to initiation of study drug administration.\n* Active or recent history of uncontrolled alcohol or other substance abuse within 3 months prior to the initiation of study drug administration.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 72 hours of study entry.",{"count":5,"type":22},[26],"This is a phase 2 trial to assess the safety and tolerability of three schedules of CUE-101 administered in the neoadjuvant phase before standard of care (SOC) therapy to treatment naïve, HLA-A\\*0201 positive patients with newly diagnosed, locally advanced HPV16+ oropharyngeal squamous-cell carcinoma (OPSCC). This is an exploratory trial of a limited sample size to confirm safety and to assess for pharmacodynamic signals of efficacy in each of three schedules of CUE-101. Safety assessments will be performed at baseline and after CUE-101 administration. To assess for efficacy, peripheral blood and tumor samples will be collected at baseline and after CUE-101 administration. Following CUE-101, patients will proceed with SOC therapy, as prescribed by the treating physician.",[33],"2026-04-30",{"date":344,"type":53},"2026-05-05",{"date":346,"type":53},"2021-12-06",{"date":348,"type":22},"2027-10-31",{"name":350,"class":100},"Washington University School of Medicine",{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":23,"phases":360,"briefSummary":361,"conditions":362,"keywords":363,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":384},"100597462","phase-2-compartmentalized-postoperative-radiotherapy-in-head-and-neck-cancer-100597462","NCT07058805","Compartmentalized Postoperative Radiotherapy in Head and Neck Cancer","COMPORT: Compartmentalization in Postoperative Radiotherapy for Head and Neck Squamous Cell Carcinoma - A Phase II Clinical Trial","COMPORT","Inclusion criteria\n\n1. ECOG performance status 0-2 at the time of registration\n2. ≥18 years of age\n3. Baseline assessments and documentation of toxicity using CTCAE v.5 and QoL using EORTC C30 and HN43 questionnaires.\n4. Histopathologically confirmed, surgically treated squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx\n5. No previous neoadjuvant systemic therapy or previous neoadjuvant systemic therapy (chemotherapy, immunotherapy or combinations) is permitted only if its neoadjuvant use for locally advanced HNSCC is approved by Swissmedic and routinely reimbursed at the time it was administered or if it was administered as part of routine institutional treatment decisions, outside of a clinical trial or other investigational framework.\n6. Standard indication for PORT via external beam radiotherapy (with or without concomitant systemic treatment) defined by a multidisciplinary head and neck tumor board (MDT).\n7. History and physical examination by treating radiation oncologist within 28 days prior to registration.\n8. MRI of the head and neck (or computerized tomography as substitute) with i.v. contrast, if not contraindicated. CT of the chest with i.v. contrast, if not contraindicated. 18FDG-PET\u002FCT can be used instead of CT of the chest. The baseline imaging examinations include the preoperative diagnostic phase and do not have to be repeated if performed within 60 days prior to the enrollment.\n9. The multidisciplinary team (MDT) must determine that the patient can safely undergo the standard treatment, which may include PORT with or without additional systemic treatment.\n10. Post-menopausal women, or women of child-bearing potential who use or agree to use effective contraception, are not pregnant and agree not to become pregnant during and within 30 days after PORT. A negative pregnancy test before inclusion (within 28 days) into the trial is required for all women with child-bearing potential. Men agree not to father a child during and within three months after PORT.\n11. Written informed consent, signed by the patient and the investigator.\n\nExclusion criteria\n\n1. Synchronous or previous malignancies. Exceptions are curatively treated basal cell carcinoma or SCC of the skin, or in situ carcinoma of the cervix uteri, low- or intermediate- risk prostate cancer, or breast with a progression-free follow-up time of at least 3 years without any remaining disease burden, or other previous malignancy with a progression-free interval of at least 5 years without any remaining active\u002Fprogressive disease burden regardless whether the treatment is completed or ongoing as a maintenance treatment (e.g. androgen deprivation therapy for prostate cancer).\n2. Presence of distant metastases c\u002FpM1.\n3. Neoadjuvant systemic therapy administered under a clinical trial protocol or as part of any structured investigational framework not considered standard institutional practice at the time of administration.\n4. Previous radiation dose applied to the anatomical sites overlapping with the standard PORT target volumes which may have a potential impact on the delivered dose and\u002For toxicity profile of the standard PORT.\n5. R2 resection of the primary tumor or any involved lymph node.\n6. Last oncologic surgery for the index HNSCC performed more than 6 weeks ago.\n7. Inadequate reporting of the pathology not conformal with COMPORT algorithm and no possibility of an adequate post-hoc acquisition of the necessary information (see the section 8)\n8. Co-existing disease prejudicing survival (expected survival less than 6 months).\n9. Active bacterial or fungal infection requiring intravenous antibiotics at the time of registration.\n10. Illness expected to preclude PORT within 7 days of registration.\n11. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n12. Ongoing participation in another interventional clinical trial which are not exempted by the sponsor. Exceptions may apply depending on the trial methodology (Please contact sponsor for clarification).",{"count":111,"type":22},[26],"COMPORT is a multicenter phase II clinical trial evaluating a personalized approach to postoperative radiotherapy in patients with head and neck squamous cell carcinoma (HNSCC). The study investigates whether a risk-adapted, compartmentalized radiotherapy strategy can safely reduce the treatment volume, and thus the side effects, without increasing the risk of tumor recurrence. Eligible patients are those with surgically treated cancers of the oral cavity, oropharynx, larynx, or hypopharynx who have a standard indication for postoperative radiotherapy. The primary outcome is the rate of recurrence in anatomical compartments that would normally be irradiated but are intentionally omitted in this study. COMPORT aims to generate high-level evidence to support a more personalized and less toxic standard of care in postoperative head and neck cancer management.",[29,30,120,33,148,147],[29,364,365,366,367,368,369,370,371,372,373,374],"radiotherapy","Postoperative Radiotherapy","De-escalation","Compartmentalization","Phase II","Quality of life","Bayesian Analysis","TAME","EORTC QLQ-C30","EORTC QLQ-HN43","adjuvant treatment","2026-04-29",{"date":377,"type":53},"2026-05-06",{"date":379,"type":53},"2026-01-15",{"date":381,"type":22},"2029-04",{"name":383,"class":100},"Olgun Elicin",3,{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":392,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":394,"conditions":395,"keywords":398,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":384},"100405868","prospective-observational-study-to-validate-circulating-hpvdna-and-prognostic-genomic-biomarkers-in-hpv-associated-opscc-100405868","NCT04564989","Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC","LCCC 2044: Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC","Inclusion Criteria:\n\n* ≥ 18 years of age\n* T0-T2 N2a-N3 M0 or T3-T4 N0-N3 M0 (AJCC 7th edition)\n* Biopsy proven squamous cell carcinoma of the oropharynx or unknown primary\n* No prior therapy\n* No evidence of distant metastatic disease\n* p16 positive = diffuse ≥ 70% tumor cell expression, with at least moderate (2\u002F3+) staining intensity\n* Planned for receipt of definitive cancer treatment\n* ECOG Performance Status 0-1\n* Patients must be deemed able to comply with the treatment plan and follow-up schedule.\n* Patients must provide study specific informed consent prior to study entry\n\nExclusion Criteria: All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation:\n\n* Prior history of radiation therapy to the head and neck\n* Prior history of head and neck cancer.\n* Inadequate pre-treatment tissue sample for tumor genomic analyses",{"count":393,"type":22},220,"The primary goal of this study is to examine whether recurrence of HPV-associated OPSCC can be predicted by two factors: 1) mutations in genes called TRAF3 and CYLD, and 2) measurements of circulating HPV DNA in blood plasma. The study will also investigate whether HPV integration is associated with TRAF3 and CYLD mutations, and whether recurrence prediction improves when looking at HPV integration along with TRAF3 and CYLD mutations.",[33,396,30,397],"Carcinoma, Squamous Cell","Oropharynx Squamous Cell Carcinoma",[399,400,401,402,403],"Human Papillomavirus","HPV","p16","Oropharynx","OPSCC","2026-04-27",{"date":406,"type":53},"2026-04-28",{"date":408,"type":53},"2020-11-19",{"date":410,"type":22},"2033-11",{"name":412,"class":100},"UNC Lineberger Comprehensive Cancer Center",{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":23,"phases":422,"briefSummary":423,"conditions":424,"keywords":425,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":384},"100459899","phase-2-risk-adapted-de-intensification-of-radio-chemotherapy-for-oropharyngeal-squamous-cell-carcinoma-100459899","NCT05268614","Risk Adapted De-Intensification of Radio-Chemotherapy for Oropharyngeal Squamous Cell Carcinoma","Risk Adapted De-Intensification of Radio-Chemotherapy for Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma Based on HPV Subtype and Plasma Circulating Free HPV DNA Level and Clearance Rate","Inclusion Criteria:\n\n1. ≥ 18 years of age (no upper age limit)\n2. T0-3, N0 to N2, M0 squamous cell carcinoma of the oropharynx by AJCC 8th Edition staging. If T0 the adenopathy must be predominantly in Level 2.\n3. Tissue diagnosis of HPV and\u002For p16 positivity from the primary site or an associated lymph node.\n4. Radiologic confirmation of the absence of lung metastasis within 12 weeks prior to treatment; at a minimum, CT of the chest is required. PET-CT is acceptable.\n5. ECOG Performance Status 0-2\n6. ≤10 pack-years of smoking or no smoking for ≥ 10 years\n7. Eligible for chemotherapy\n8. CBC\u002Fdifferential obtained within 12 weeks prior to treatment, with adequate bone marrow function defined as follows:\n\n   * Platelets ≥ 100,000 cells\u002Fmm3\n   * Hemoglobin ≥ 8.0 g\u002Fdl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002Fdl is acceptable.)\n9. Adequate renal and hepatic function within 12 weeks prior to treatment, defined as follows:\n\n   * Serum creatinine \\\u003C 2.0 mg\u002Fdl\n   * Total bilirubin \\\u003C 2 x the institutional ULN (upper limit of normal)\n   * AST or ALT \\\u003C 3 x the institutional ULN\n   * Note that physician attestation of patient having no known history of liver disease can take the place of bilirubin and AST\u002FALT labs.\n10. Negative pregnancy test within 3 weeks prior to treatment for women of childbearing potential.\n11. People of childbearing potential (POCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 14 months after the last dose of study drug to minimize the risk of pregnancy. Prior to study enrollment, people of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.\n\n    POCBP includes any person who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal. Post-menopause is defined as:\n    * Amenorrhea that has lasted for ≥ 12 consecutive months without another cause, or\n    * For people with irregular menstrual periods who are taking hormone replacement therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of greater than 35 mIU\u002FmL.\n12. Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 14 months following the last dose of study drug.\n13. Patients must provide study specific informed consent prior to study entry.\n\nExclusion Criteria:\n\n1. Prior radiotherapy for oropharyngeal squamous cell carcinoma (OPSCC) OR to the head and neck that, if combined with the protocol therapy, is deemed likely to compromise critical organs at risk in the opinion of the investigator.\n2. Prior cancer within the last 10 years.\n\n   •This exclusion does not apply to the history or presence of any non-oropharynx cancer when the treating physician (or PI) deems that it is resolved or expected to have an indolent growth rate such that evaluation of the efficacy of the study treatment is unlikely to be compromised.\n3. Prior surgery with curative intent for this OPSCC.\n4. Patients who have undergone tonsillectomy for diagnosis or excisional biopsy of a neck node for diagnosis are eligible provided there is \"gross\" cancer present at the primary site or in the neck at the start of radiation therapy on this protocol with \"gross\" defined as visible on an imaging study.\n5. Inhalation smoking of tobacco within the last 10 years with \\> 10 pack-year equivalent history.\n6. Currently taking Disease Modifying Rheumatoid Drugs (DMRDs) or immunosuppressive medication, for example as for organ transplant or multiple sclerosis.\n7. Severe, active co-morbidity, defined as follows:\n\n   * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months\n   * Transmural myocardial infarction within the last 6 months\n   * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\n   * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration\n   * Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects; Note, however, coagulation parameters are not required for entry into this protocol.\n   * Evidence of ACTIVE systemic lupus or scleroderma\n   * Psoriatic arthritis\n8. Known HIV positivity. HIV positive patients are known to have worse clinical outcomes especially for local, regional, and distant cancer control. This poorer prognosis is thought to be secondary to a compromised immune system. Thus, de-intensification of radiation and chemotherapy is not justifiable in this population. HIV testing at the time of enrollment is not required.\n9. Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 14 months after the last dose of study drug.\n10. People who are pregnant or breastfeeding.\n11. Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.",{"count":421,"type":22},250,[26],"This study builds on the results of several prior studies that we have been involved with to test the hypothesis that Risk-Adapted De-Intensification of Radiation Therapy and chemotherapy based on HPV subtype, plasma circulating free HPV DNA (cfHPV DNA) level, and cfHPV DNA clearance rate produces Local-Regional Control rates that are similar to what has been achieved with more aggressive therapy in patients with Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma (OPSCC).",[33],[33,426,427],"chemo-radiotherapy","cfHPV DNA","2026-04-23",{"date":430,"type":53},"2026-04-24",{"date":432,"type":53},"2022-05-16",{"date":434,"type":22},"2032-06",{"name":436,"class":100},"University of Florida",{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":23,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":61},"100566967","remote-audiometry-to-monitor-for-treatment-related-hearing-loss-in-patients-with-hn-scc-receiving-cisplatin-andor-radiation-100566967","NCT06662058","Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and\u002For Radiation","Ototoxicity Monitoring and Remote Audiometry","Inclusion Criteria:\n\n* Adult patients, male or female, aged ≥ 18, able to provide informed consent\n* Subjects with pathologically proven HNSCC involving the oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, skin, or paranasal sinuses; patients with unknown primary HNSCC involving the cervical lymph nodes can also be included. Patients can have previously untreated or recurrent\u002Fmetastatic disease\n* Subjects who will be treated with cisplatin chemotherapy and\u002For radiation. For radiation alone, patients should have tumors near the inner ear, including the nasopharynx, temporal bone, and\u002For parotid salivary gland\n* Life expectancy of more than 3 months, as determined by the investigator\n\nExclusion Criteria:\n\n* Patients with profound hearing loss in both ears, which precludes an accurate hearing test. This can be determined based on patient report\u002Fhistory or audiogram done before or after informed consent\n* Patients who are unable to participate in a hearing test (per the investigator's judgment)",{"count":445,"type":22},118,[113],"This clinical trial tests the impact of offering hearing tests (audiometry) close to home and remotely on participation in monitoring for treatment-related hearing loss in patients with head and neck squamous cell cancer receiving cisplatin and\u002For radiation. Cisplatin, a chemotherapy often used to treat head and neck cancers, and radiation given near the ear can cause hearing loss in some patients. Hearing loss can have a major negative impact on quality of life, contributing to social isolation and frustration. Identifying hearing changes may allow treatment changes to prevent further loss. Audiometry measures hearing loss using a graphic record of the softest sounds that a person can hear at various frequencies. It is recommended patients have a hearing test before, during and after treatment to monitor for any hearing loss. This is usually done in the office and performed on the same day as other visits whenever possible, however, patients who live far away or have stage IV cancer, may have more difficulty coming back for hearing tests. Offering close to home and remote audiometry may improve monitoring for hearing loss in patients with head and neck squamous cell cancer receiving cisplatin and\u002For radiation.",[449,450,451,30,147,148,452,453,454,455,456,457,458,459,149,120,33,460,461,294,295,296,462,298,299,463,464,465,466,467,468,300,469],"Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Cutaneous Squamous Cell Carcinoma of the Head and Neck","Head and Neck Carcinoma of Unknown Primary","Metastatic Cutaneous Squamous Cell Carcinoma of the Head and Neck","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Hypopharyngeal Squamous Cell Carcinoma","Metastatic Laryngeal Squamous Cell Carcinoma","Metastatic Nasopharyngeal Squamous Cell Carcinoma","Metastatic Oral Cavity Squamous Cell Carcinoma","Metastatic Oropharyngeal Squamous Cell Carcinoma","Metastatic Paranasal Sinus Squamous Cell Carcinoma","Paranasal Sinus Squamous Cell Carcinoma","Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck","Recurrent Nasopharyngeal Squamous Cell Carcinoma","Recurrent Paranasal Sinus Squamous Cell Carcinoma","Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8","Stage IV Hypopharyngeal Carcinoma AJCC v8","Stage IV Laryngeal Cancer AJCC v8","Stage IV Lip and Oral Cavity Cancer AJCC v8","Stage IV Nasopharyngeal Carcinoma AJCC v8","Stage IV Sinonasal Cancer AJCC v8","2026-04-20",{"date":428,"type":53},{"date":473,"type":53},"2025-03-12",{"date":475,"type":22},"2029-10-31",{"name":477,"class":100},"Emory University",{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":498,"locationsCount":61},"100543469","oropharynx-opx-biomarker-trial-100543469","NCT06356272","Oropharynx (OPX) Biomarker Trial","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Able to provide written consent\n* Groups 1-3:\n\n  * Must undergo p16 staining on biopsy for enrollment\n  * Patients with \\\u003C 70% of tumor cells positive for p16 will be considered p16 negative\n  * Must undergo HPV16 family in situ hybridization (ISH) and\u002For RNA on biopsy or surgical specimen, unless amount of tissue is too small to have conclusive HPV ISH testing done on it\n  * Willingness and intent to return in person to enrolling institution for follow-up (during the Active Monitoring Phase of the study) for at least 2 of the standard follow-up time points for a total of 3 time-points including pre-treatment. A participant who does not return in person to Mayo Clinic Rochester for every standard of care post-treatment follow up will not be considered deviating from the protocol\n* Group 4:\n\n  * Clinical suspicion or histopathologic diagnosis of head and neck cancer or neoplasm\n\n    * Primary salivary neoplasm\n    * Primary thyroid neoplasm\n    * Primary head and neck neoplasm\n    * Multi-cancer early detection (MCED) testing concerning for cancer\n* Patient has given permission to give his\u002Fher tumor\u002Ftissue\u002Fblood\u002Fsaliva sample for research testing\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Primary language: English, Spanish, Arabic\n\nExclusion Criteria:\n\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.\n* Groups 1-3:\n\n  * Other active malignancy ≤ 5 years prior to registration\n\n    * EXCEPTIONS: Non-melanotic skin cancer, non-metastatic thyroid cancer, non-metastatic prostate cancer, carcinoma-in-situ of the cervix, HPV+ oropharyngeal squamous cell carcinoma (SCC) (which can be enrolled in group 3)\n    * NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer\n  * History of any head and neck malignancy, other than the tumor for which they are being treated\n* Group 4, Cohort A, B, C:\n\n  * Other active malignancy ≤ 5 years prior to registration\n\n    * EXCEPTIONS: Non-metastatic prostate cancer, carcinoma-in-situ of the cervix, non metastatic cutaneous basal cell carcinoma\n    * NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer\n  * History of any head and neck malignancy, other than the present neoplasm\n  * Note these are clarifications of inclusion into Group 4, Cohorts D and E:\n\n    * Presence of other active malignancy or recurrent head and neck neoplasms are allowed in this arm\n    * Receipt of cancer specific therapy for other malignancy is allowed in this arm",{"count":485,"type":22},560,"The purpose of this research is to identify a biomarker that is exists when human papillomavirus (HPV) mediated oropharyngeal squamous cell carcinoma is present and does not exist when HPV mediated oropharyngeal squamous cell carcinoma is absent.",[146,449,458,33,299,171,300,488,489,490,491],"Head and Neck Carcinoma","Head and Neck Neoplasm","Salivary Gland Neoplasms","Thyroid Gland Neoplasm","2026-04-17",{"date":494,"type":53},"2026-04-22",{"date":496,"type":53},"2019-11-15",{"date":216,"type":22},{"name":499,"class":100},"Mayo Clinic",{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":23,"phases":510,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":525},"100611491","spect-ct-guided-elective-contralateral-neck-treatment-in-lateralized-oropharyngeal-cancer-100611491","NCT07241273","SPECT-CT Guided ELEctive Contralateral Neck Treatment in Lateralized Oropharyngeal Cancer","SPECT-CT Guided ELEctive Contralateral Neck Treatment in Lateralized Oropharyngeal Cancer: A Phase II Trial","SELECT-FR","Inclusion Criteria:\n\n1. Patients must have signed a written informed consent form prior to any trial specific procedures.\n2. Patients with histologically confirmed T1-T3 M0 lateralized OPC (tonsil, soft palate, pharyngeal wall or base of tongue) not involving or crossing midline. Nodal disease may include no node or single or multiple ipsilateral lymph nodes (largest should be equal or less than 6 cm in maximum diameter) without contralateral nodes involved. For HPV-positive patients, this includes N0-N1. For HPV-negative patients, this includes N0-N2b. Patients with radiologic extranodal extension without clinical signs of extranodal extension (skin invasion, deep nodal fixation, and\u002For clinical signs of cranial nerve or brachial plexus invasion) will be eligible for participation.\n3. HPV-positive or -negative (by p16 immunohistochemistry). Tumours will be classified as p16 at local sites based on greater than 70% strong diffuse nuclear or nuclear and cytoplasmic staining.\n4. Planned definitive bilateral neck radiotherapy with or without concurrent chemotherapy.\n5. Patients ≥ 18 years old.\n6. ECOG Performance Status 0-1.\n7. The following radiological investigations must have been done within 8 weeks before randomization:\n\n   * CT or MRI of the neck (with head imaging as indicated);\n   * PET-CT scan;\n   * Chest CT scan.\n8. Patients who receive a concomitant chemoradiotherapy (cCRT) should have adequate organ and bone marrow function including the following:\n\n   * Hematological function (absolute neutrophil count ≥ 1.5 x10⁹\u002FL, platelets ≥ 100 x10⁹\u002FL, hemoglobin ≥ 9 g\u002FdL) measured before cCRT.\n   * Renal function (creatinine clearance ≥ 50 mL\u002Fmin per Cockcroft and Gault formula) measured before cCRT.\n   * Hepatic function (total bilirubin \\\u003C 1.5 ULN, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \\\u003C 2.5 ULN, Alkaline phosphatase \\\u003C 2.5 ULN) measured before cCRT.\n9. Women\u002Fmen of childbearing potential must have agreed to use a highly effective contraceptive method up to 90 days after completing radiotherapy.\n\n   Women of childbearing potential must have a negative pregnancy test before the beginning of the trial.\n10. Treating surgeon must confirm that the patient is a candidate to undergo injection procedure for lymphatic mapping in either the nuclear medicine, ambulatory clinic, or operating room setting.\n11. Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.\n12. Patients affiliated to (or beneficiary from) the French social security system.\n13. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\nExclusion Criteria:\n\n1. Patients with T1-T2 cancers isolated to the tonsil fossa (i.e., without any soft palate, tongue base, posterior pharyngeal wall or posterior tonsil pillar involvement) with no involved lymph nodes or with a single ipsilateral node \\\u003C 3 cm without extranodal extension.\n2. Patients with tonsil or tongue base primary squamous cell carcinoma who have previously undergone diagnostic palatine or lingual tonsillectomy with either complete excision or with no clinically apparent residual disease are excluded. However, patients who have had previous deep biopsies or partial excisions with clinically evaluable disease are still eligible.\n3. Previous head and neck cancer or multiple synchronous primary head and neck cancers.\n4. Previous induction or neo-adjuvant chemotherapy.\n5. Previous radiation therapy to the head and neck or comprehensive neck dissection of at least 3 levels on either side (due to potential for disrupted lymphatic channels and drainage pathways). Patients who have had excisional biopsies of involved lymph nodes are, however, still eligible.\n6. Previous radiotracer allergy. Contraindication in patients with history of hypersensitivity to human albumin-containing products.\n7. Patients with severe, active co-morbidity including any of the following:\n\n   * Chronic Obstructive Pulmonary Disease or other pulmonary illness requiring hospitalization within 30 days of registration.\n   * Unstable angina and\u002For congestive heart failure requiring hospitalization within the 30 days of registration.\n   * Acute myocardial infarction within 30 days of study registration.\n   * Diseases precluding RT (e.g., scleroderma).\n8. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, as assessed by the investigator.\n9. Pregnant or breastfeeding women.\n10. Patient enrolled in another therapeutic trial within 30 days of registration.\n11. Persons deprived of their liberty or under protective custody or guardianship.",{"count":509,"type":22},128,[113],"Oropharyngeal cancer (OPC) is the most common type of head and neck cancer. The current standard treatment for this cancer is radiotherapy (RT) of the tumour and lymph nodes of both sides of the neck, combined with concurrent chemotherapy for advanced stages. Even though a small proportion of patients with this cancer have involvement of the lymph nodes of the neck on the opposite side of the tumour (contralateral involvement) or involvement of the lymph nodes on both sides of the neck (bilateral involvement), bilateral radiotherapy is performed due to the risk of contralateral microscopic involvement, which is invisible on imaging and clinical examination. Bilateral radiotherapy causes more adverse events, leading to a decrease in quality of life.\n\nLymphatic mapping using Single Photon Emission Computed Tomography-Computed Tomography (SPECT-CT) imaging is a technique that visualises the lymphatic drainage of the tumour and thus determines whether radiotherapy should be delivered unilaterally or bilaterally to the lymph nodes. This technique would therefore reduce adverse events and improve quality of life, while maintaining the efficacy of radiotherapy.\n\nThe goal of the clinical trial SELECT-FR is to investigate if the efficacy of a lymphatic drainage mapping with a SPECT-CT-guided approach is acceptable in terms of two-year Disease Free Survival (DFS) rate in patients with lateralized OPC.",[33,513,514,46,29,515],"Oropharyngeal Cancers","Oropharyngeal Carcinoma","Head and Neck Cancers","2026-03-23",{"date":518,"type":53},"2026-03-24",{"date":520,"type":22},"2026-04",{"date":522,"type":22},"2031-04",{"name":524,"class":100},"UNICANCER",12,{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":23,"phases":535,"briefSummary":536,"conditions":537,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":61},"100540946","phase-2-adaptive-de-intensified-radiotherapy-using-circulating-tumor-dna-in-hpv--associated-oropharyngeal-cancer-100540946","NCT06323460","Adaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer","A Pilot Study of Adaptive De-Intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer","Inclusion Criteria:\n\n* Pathologically confirmed diagnosis of squamous cell carcinoma of the oropharynx (unknown primary, base of tongue, tonsil, oropharyngeal walls, soft palate). Cytologic or fine needle aspiration (FNA) confirmation is sufficient if a biopsy of the primary tumor is not feasible\n* P16 positive immunohistochemical staining. FNA may be used as the sole diagnostic tissue. If staining was done at an outside hospital, central review by the Ohio State University (OSU) department of pathology must occur prior to trial enrollment\n* Clinical stage T0, N1-N2, T1-2, N1-N2, T3-T4, N0-2 (American Joint Committee on Cancer \\[AJCC\\] 8th edition) including no evidence of distant metastases based on general history, imaging, physical examination, and examination with laryngopharyngoscopy\n* Clinical or radiographic evidence of measurable disease at the primary site or lymph nodes. Simple tonsillectomy or excision of primary without removal of nodal disease is permitted, as is excision of gross nodes but with intact primary site\n* Fludeoxyglucose F-18 (FDG) PET\u002FCT from the base of skull to the mid-thigh is mandatory and patients cannot be enrolled without a pretreatment PET\u002FCT. PET\u002FCT must be completed prior to enrollment\n* Pretreatment tumor tissue modified HPV virus (TTMV-HPV) particles present in plasma cell free DNA value of \\>= 200 copies\u002FmL at baseline\n* Patients must provide their smoking history prior to enrollment. Patients must have =\\\u003C 10 pack years of smoking. The number of pack years will be calculated using the following formula: Frequency of smoking (cigarettes\u002Fday) x duration of cigarette smoking (years)\u002F20\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Age \\>= 18\n* Absolute neutrophil count: ≥ 1500\u002FmcL (within 14 days prior to registration)\n* Platelets: \\>= 100,000\u002FmcL (within 14 days prior to registration)\n* Hemoglobin \\>= 8.0 g\u002FdL (use of transfusion or other intervention to achieve this is acceptable) (within 14 days prior to registration)\n* Total bilirubin \\>= 1.5 x institutional upper limit of normal (within 14 days prior to registration)\n* Aspartate transaminase (AST) or alanine transaminase (ALT) \\>= 3.0 x institutional upper limit of normal (within 14 days prior to registration)\n* Serum creatinine =\\\u003C 1.5 x institutional upper limit of normal or creatinine clearance \\>= 50 mL\u002Fmin (Cockcroft-Gault Formula) (within 14 days prior to registration)\n* Human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible\n* Patients with known positive hepatitis B surface antigen indicating acute or chronic infection would make patient ineligible unless viral load becomes undetectable on suppressive therapy\n* Patients with history of hepatitis C virus must have been treated and cured\n* For women of childbearing potential, negative serum or urine pregnancy test within 14 days of registration\n* Patient or legally authorized representative must provide study specific informed consent prior to study entry\n\nExclusion Criteria:\n\n* Recurrent disease\n* Clinical or radiographic evidence of metastatic disease or adenopathy below the clavicles\n* Cancers from an oral cavity site, even if p16 positive\n* Patients with simultaneous primary cancers or separate bilateral primary tumors will be excluded, except for patients with bilateral tonsil cancers\n* Prior invasive malignancy (except non-melanoma skin cancer) unless disease free for a minimum of 3 years\n* Prior systemic chemotherapy or immunotherapy\n* Prior radiotherapy that would result in overlap of radiation fields\n* Severe active co-morbidity defined as: Unstable angina or congestive heart failure requiring hospitalization in the last 6 months. Condition requiring systemic treatment with steroids or immunosuppressive medications within 14 days of registration\n* Patients with active autoimmune disease requiring systemic treatment (disease modifying agents, corticosteroids, or immunosuppressive drugs\n* Patients who are pregnant, nursing, or expected to conceive or father children\n* Patients who are allergic to cisplatin, carboplatin, or paclitaxel",{"count":534,"type":22},45,[26],"This phase II trial studies how well using circulating tumor deoxyribonucleic acid (DNA) to guide lower dose radiation therapy works in treating patients with human papillomavirus infection (HPV)-associated oropharyngeal cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Recently, a blood test has been developed to detect the human papillomavirus in the blood and determine how many viral particles are present. Researchers want to compare any good and bad effects of using the lower dose radiation therapy with chemotherapy compared to the usual standard of care dose chemotherapy in patients who clear the human papillomavirus particles from their blood.",[144,145,33],"2026-03-20",{"date":518,"type":53},{"date":541,"type":53},"2024-03-21",{"date":543,"type":22},"2026-12-31",{"name":545,"class":100},"Ohio State University Comprehensive Cancer Center",{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":553,"conditions":554,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":565},"100480719","the-role-of-circulating-tumour-dna-in-head-and-neck-cancer-100480719","NCT05539638","The Role of Circulating Tumour DNA in Head and Neck Cancer","Inclusion Criteria:\n\n* Patients with oropharyngeal squamous cell carcinoma\n* Both HPV positive and negative disease\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* Those who lack capacity to consent\n* Patients with non-squamous cell carcinoma\n* Patients with squamous cell carcinoma out with the oropharynx",{"count":421,"type":22},"Cancers of the throat, oropharyngeal squamous cell carcinoma (OPSCC), are highly prevalent across Scotland. Over the past 10 years, both global and Scottish cases of OPSCC have increased, particularly those associated with human papillomavirus (HPV). However there has been little change in techniques for diagnosis and monitoring. Although imaging technologies are improving, results of imaging are often indeterminate and clinicians require additional tools to make informed decisions. With this in mind our research team have established a range of blood- based tests which detect and monitor cancer DNA fragments shed by tumours into the blood stream in OPSCC patients. Our initial studies have shown that such tests, which are minimally invasive compared to surgical biopsy, hold the potential to provide an accurate, \"real-time\" method to monitor patient response to treatment, identify early relapse and assist in clinical decision making. The investigators aim to expand these results to assist clinical decisions for both virally associated and non-viral associated OPSCC. Following this, the investigators will focus on the poorest prognosis OPSCC group (non-HPV tumours) by applying state-of-the-art DNA detection and sequencing technologies to analyse tumour- derived DNA fragments in the bloodstream, to follow treatment response and to develop new methods for detecting relapse and resistance to treatment in OPSCC. Ultimately, the investigators envisage that the implementation of such genetic assays of tumours and the fragments that they release into the bloodstream will provide a transformative shift in the clinical assessment and quality of life of OPSCC patients in Scotland.",[33,555],"Human Papillomavirus (HPV)","2026-03-13",{"date":558,"type":53},"2026-03-17",{"date":560,"type":53},"2022-08-14",{"date":562,"type":22},"2027-08-31",{"name":564,"class":100},"University of Edinburgh",5,{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":572,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":23,"phases":576,"briefSummary":577,"conditions":578,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":61},"100596375","phase-2-shortened-course-of-radiation-therapy-after-trans-oral-robotic-surgery-in-patients-with-hpv-mediated-oropharyngeal-squamous-cell-carcinoma-100596375","NCT07044635","Shortened Course of Radiation Therapy After Trans-oral Robotic Surgery in Patients With HPV-Mediated Oropharyngeal Squamous Cell Carcinoma.","Radiation Therapy in Reduced Dose and Hypofractionated Schedule After Trans-Oral Robotic Surgery in Intermediate Risk HPV-Mediated Oropharyngeal Squamous Cell Carcinoma","RAD RAPTORS","Step 1 Registration: Pre-Operative Eligibility\n\nInclusion Criteria:\n\n* Participant aged ≥ 18 years.\n* Diagnosis of oropharyngeal squamous cell carcinoma.\n* Eligible to receive transoral robotic surgery.\n* If status is known, p16 positivity or HPV positivity by in situ hybridization on pathological sampling of lymph node or primary oropharyngeal tumor. If status not known at the time of step-1 registration, otherwise eligible participants may be enrolled and HPV\u002Fp16 status must be determined prior to step-2 registration.\n* Pre-operative TTMV-HPV DNA test collected or is planned to be collected. Pre-operative TTMV-HPV DNA may be collected anytime up until the day of surgery as long as it is prior to surgery.\n\n  * Standard of care tests completed within 60 days of registration may be used for screening.\n  * Tests results are not required to confirm eligibility for step 1 registration.\n* ECOG Performance Status ≤ 2\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n\nExclusion Criteria:\n\n* History of prior mucosal head and neck cancer treated with radiation therapy\n* Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this study\n* Participant has smoked cigarettes within 1 month of registration\n* Prior systemic anti-cancer therapy or any investigational therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter.\n* Known distant metastatic disease.\n* Current evidence of any condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection\u002Finflammation, intestinal obstruction, unable to swallow medication, \\[participants may not receive the drug through a feeding tube\\], social\u002F psychological issues, etc.)\n* Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.\n\nStep 2 Registration - Experimental Arm\n\nInclusion Criteria:\n\n* Completion of trans-oral robotic surgery.\n* Pre- and post-operative TTMV-HPV DNA test results obtained.\n* P16 positivity or HPV positivity by in situ hybridization on pathological sampling of lymph node or primary oropharyngeal tumor\n* For participants of childbearing potential: Negative pregnancy test or evidence of permanent surgical sterilization. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n  * \\\u003C 50 years of age:\n\n    * Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\n    * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution\n  * ≥ 50 years of age:\n\n    * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\n    * Had radiation-induced menopause with last menses \\>1 year ago; or\n    * Had chemotherapy-induced menopause with last menses \\>1 year\n* Participants of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.5.2.\n\nExclusion Criteria:\n\n* Meets ALL of the following criteria for low-risk disease (Note: participants may meet some without being excluded):\n\n  * Pre-operative TTMV-HPV DNA positive\n  * Post-operative TTMV-HPV DNA negative\n  * Disease: pT1 with ≤ 1 lymph nodes OR pT2N0\n  * \\\u003C10 pack year smoking\n  * No extranodal extension\n  * Negative surgical margins\n  * No perineural invasion\n  * No lymphovascular invasion\n* Meets ANY of the following criteria for high-risk:\n\n  * Post-operative TTMV-HPV DNA positive\n  * Surgical margin positive --\\>1 mm extranodal extension --≥ 5 lymph nodes\n* Current evidence of any condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection\u002Finflammation, intestinal obstruction, unable to swallow medication, \\[participants may not receive the drug through a feeding tube\\], social\u002F psychological issues, etc.)\n\nStep 2 Registration - Exploratory Arm Inclusion Criteria\n\n* Completion of trans-oral robotic surgery.\n* Pre- and post-operative TTMV-HPV DNA test results obtained.\n* Meets ANY of the following criteria:\n* Post-operative TTMV-HPV DNA positive or indeterminate\n* Surgical margin positive\n* \\>1 mm extranodal extension\n* ≥5 lymph nodes\n* Pre-operative TTMV-HPV DNA score of ≤ 50\n* For participants of child bearing potential: Negative pregnancy test or evidence of permanent surgical sterilization. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n  * \\\u003C 50 years of age:\n\n    * Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\n    * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution\n  * ≥ 50 years of age:\n\n    * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\n    * Had radiation-induced menopause with last menses \\>1 year ago; or\n    * Had chemotherapy-induced menopause with last menses \\>1 year\n* Participants of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.5.2.\n\nExclusion Criteria\n\n* Pre-operative TTMV-HPV DNA score of \\> 50.\n* Current evidence of any condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection\u002Finflammation, intestinal obstruction, unable to swallow medication, \\[participants may not receive the drug through a feeding tube\\], social\u002F psychological issues, etc.).",{"count":575,"type":22},42,[26],"The goal of this study is to evaluate if a shorter course of therapy can improve the quality of life in patients receiving radiation therapy after trans-oral robotic surgery.",[33,579],"HPV-mediated Oropharyngeal Squamous Cell Carcinoma","2026-02-24",{"date":582,"type":53},"2026-02-27",{"date":584,"type":53},"2025-07-23",{"date":586,"type":22},"2030-08",{"name":588,"class":100},"University of Utah",{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":4,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":596,"targetDuration":4,"studyType":23,"phases":598,"briefSummary":599,"conditions":600,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":61},"100625862","phase-1-lattice-based-radiotherapy-and-chemoimmunotherapy-for-oropharyngeal-squamous-cell-carcinoma-100625862","NCT07428148","Lattice-Based Radiotherapy and Chemoimmunotherapy for Oropharyngeal Squamous Cell Carcinoma","Phase I\u002FII Trial of Induction Lattice-Based Radiotherapy and Chemoimmunotherapy Preceding Response-Adapted Definitive Chemoradiation for Non-Low Risk Oropharyngeal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oropharynx, which includes the sites tonsil, base of tongue, soft palate, or posterior oropharyngeal wall. Histologic variants will be included (papillary squamous cell carcinoma and basaloid squamous cell carcinoma). Cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx.\n* Clinical stage T1-T4, N1-N3, M0\n* If tissue is positive for p16 by immunohistochemical staining (\\>70% staining), patient must have \\>10 pk-year smoking history\n* Zubrod Performance Status of 0-1\n* Primary tumor ≥ 3 cm OR at least one lymph node ≥ 3 cm OR primary tumor and lymph node ≥ 3 cm\n* One of the following combinations of imaging is required within 8 weeks of registration: CT scan of the neck (with contrast) and a whole body PET\u002FCT; or, an MRI of the neck (with contrast) and a whole body PET\u002FCT. Note: A CT scan of the neck and\u002For a PET\u002FCT performed for the purposes of radiation planning may serve as both staging and planning tools.\n* Patients must provide their personal smoking history prior to registration. Patients with HPV positive oropharyngeal carcinoma must have a cumulative personal smoking history that exceeds 10 pack-years. Number of pack-years = \\[Frequency of smoking (number of cigarettes per day) x duration of cigarette smoking (years)\\] \u002F 20. Note: Twenty cigarettes is considered equivalent to one pack. Cigar and pipe tobacco consumption is not included in calculating lifetime pack-years.\n* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential. Female subjects of childbearing potential and male subjects with female partners of childbearing potential must be willing to avoid pregnancy. Female subjects of childbearing potential who are undergoing RT or who are partners to male subjects in the study should avoid sexual activity or use a highly effective method of birth control during sexual intercourse. Acceptable, highly effective methods of birth control include: intrauterine device (IUD)\u002Fintrauterine hormone releasing system (IUS), bilateral tube occlusion, vasectomized partner, combined (estrogen and progesterone containing) or progesterone-only hormonal contraceptives (oral, intravaginal, transdermal, injectable).\n* Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception (abstinence\u002Fprotection) for the duration of treatment\u002Fstudy participation.\n* The patient must provide study-specific informed consent prior to study entry.\n* Adequate renal function within 2 weeks prior to registration, defined as follows:\n* Serum creatinine ≤ 1.5 mg\u002Fdl or creatinine clearance (CC) ≥ 50 ml\u002Fmin determined by 24 hour collection or estimated by Cockcorft-Gault formula.\n* Adequate hematologic function within 2 weeks prior to registration, defined as follows: Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3; Platelets ≥ 100,000 cells\u002Fmm3; and Hemoglobin ≥ 8.0 g\u002Fdl. Note: the use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002Fdl is acceptable\n* Patients who are HIV positive but who have no prior AIDS-defining illness and have CD4 cells of at least 350\u002Fmm3 are eligible. HIV-positive patients must not have multi-drug resistant HIV infection or other concurrent AIDS-defining conditions. Patients must not be sero-positive for Hepatitis B (Hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or sero-positive for Hepatitis C (anti-Hepatitis C antibody positive). However, patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B).\n* The patient must provide study-specific informed consent prior to study entry.\n\nExclusion Criteria:\n\n* Cancers considered to be from an oral cavity site (oral tongue, floor of mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive;\n* Carcinoma of the neck of unknown primary site origin (even if p16 positive)\n* Distant metastasis or adenopathy below the clavicles;\n* Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease.\n* Simultaneous primary cancers or separate bilateral primary tumor sites;\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);\n* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;\n* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;\n* Severe, active co-morbidity defined as follows:\n\n  1. Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months;\n  2. Transmural myocardial infarction within the last 6 months;\n  3. Acute bacterial or fungal infection intravenous antibiotics at the time of registration;\n  4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration;\n  5. Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol other than those listed in 5.1.\n  6. Acquired immune deficiency syndrome (AIDS) based upon the current CDC definition with immune compromise greater than that noted in section 5.1; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immune-compromised patients.\n* Pregnancy; this exclusion is necessary because the treatment in this study may be significantly teratogenic\n* Prior allergic reaction to cisplatin.\n* Exclusion Criteria for MRI: Normal MRI exclusion criteria will apply, including those on the following list. A standard MRI safety form will be used to identify potential conditions warranting exclusion.\n* Electrical implants such as cardiac pacemakers or perfusion pumps\n* Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants\n* Ferromagnetic objects such as jewelry or metal clips in clothing\n* Claustrophobia\n* History of seizures\n* Patients with GFR \\\u003C 15 ml\u002Fmin\u002F1.73m2 or who are on dialysis will not have DCE-MRI scan. These patients will have conventional anatomical MRI without contrast and DW-MRI.",{"count":597,"type":22},60,[25,26],"This single-arm Phase I\u002FII trial evaluates induction chemoimmunotherapy combined with lattice radiotherapy (LRT) in patients with non-low risk oropharyngeal squamous cell carcinoma and primary tumor ≥3 cm or primary tumor and pathologic lymph node ≥3 cm in longest dimension. BOIN12 adaptive dose-finding will guide dose across two anatomical cohorts-primary-tumor only (P) and primary + largest involved node (PN)-with a total target accrual of about 60 evaluable patients.\n\nDose-limiting toxicity is monitored separately in each cohort. If both tolerate the same dose, that unified optimal biological dose (OBD) advances to Phase II; if tolerability differs, the PN-specific OBD expands while the P cohort is analyzed descriptively.\n\nAfter induction, imaging determines response: patients achieving ≥50% volumetric tumor shrinkage receive hypofractionated chemoradiation, whereas those with \\\u003C50% shrinkage are treated with conventional fractionation, personalizing definitive therapy according to early safety and efficacy signals.",[33],"2026-02-17",{"date":603,"type":53},"2026-02-23",{"date":605,"type":22},"2026-05",{"date":607,"type":22},"2033-05",{"name":609,"class":100},"NYU Langone Health",{"id":611,"slug":612,"hasResults":12,"nctId":613,"briefTitle":614,"officialTitle":614,"acronym":615,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":617,"targetDuration":4,"studyType":23,"phases":619,"briefSummary":620,"conditions":621,"keywords":631,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":643,"completionDateStruct":644,"leadSponsor":645,"locationsCount":4},"100625084","phase-2-a-single-arm-phase-ii-trial-in-p16-positive-oropharynx-cancer-of-selective-dose-de-escalation-of-nodal-volumes-at-minimal-risk-and-primary-site-disease-saved-100625084","NCT07418034","A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)","SAVED","4.1 Step 1 Registration 4.1.1 Step 1 Inclusion\n\n(Y) 1. Is there pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx or squamous cell carcinoma unknown primary? Note: specimen from cervical lymph nodes with a well-defined primary site documented clinically or radiologically is acceptable; in patients with carcinoma of unknown primary this will be sufficient for pathologic confirmation without a clinically or radiographically defined primary site.\n\n(Y) 2. Is the patient ≥ 18 years of age?\n\n(Y) 3. Did the patient provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required p16 review?\n\n(Y) 4. Clinical TNM staging criteria by cohort (AJCC 8th edition):\n\nTORS candidate patients must be:\n\n• cT0-4 and N0, N1, N3\n\nNon-TORS candidate patients must be either:\n\n* cT1-4 N0, N1, N3\n* cT1-3 N2 with \\\u003C 10 pack years\n\n4.1.2 Step 1 Exclusion\n\n(N) 1. Patient who are clinical N2 and have ≥10 pack years smoking history\n\n(N) 2. Patients who are clinical T4N2\n\n(N) 3. Patients with distant metastasis (M1)\n\n4.2 Step 2 Registration 4.2.1 Step 2 inclusion\n\n(Y) 1. Does the patient have pathologically (histologically or cytologically) proven P16+ status?\n\n(Y) 2. Does the patient have appropriate imaging (PET\u002FCT preferred, CT neck with IV contrast and CT chest without contrast as recommended alternative to PET\u002FCT) completed within 90 days of enrollment?\n\n(Y) 3. Does the patient have clinical or pathological M0 staging? (Y) 4. Patients who have undergone TORS must have pathological stage pT1-4 N0, N1 or N3. TORS patients found to be clinical N2 post TORS or have contralteral neck dissection and positive nodes will be excluded.\n\n(Y) 5. Is the patient a candidate for bilateral radiation based on evaluation by ENT, Rad Onc, or Med Onc and review at multi-disciplinary tumor board?\n\n(Y) 6. Non-TORS patients who are cT1-3 N0, N1, N2 and have \\\u003C10 PY must have completed a ctDNA evaluation prior to Step 2 enrollment.\n\n(Y) 7. Non-TORS patients who are cT1-3 N2 must have a positive ctDNA result prior to Step 2 enrollment.\n\n(Y) 8. Was a general history and physical examination performed by a radiation oncologist, medical oncologist, or head and neck surgeon within 60 days prior to registration?\n\n(Y) 9. Was the patient's Zubrod Performance Status 0-1 within 30 days prior to registration?\n\n(Y) 10. If a woman of child-bearing potential or sexually active male, is the patient willing to use effective contraception throughout their participation in the treatment phase of the study and at least 180 days following the last study treatment.\n\n4.2.2 Step 2 Exclusion\n\n(N) 1. Does the patient have cancer considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), nasopharynx, hypopharynx, or larynx?\n\n(N) 2. Does the patient have distant metastasis?\n\n(N) 3. Does the patient have prior invasive malignancy (except non-melanomatous skin cancer and low\u002Fintermediate risk prostate cancer) unless disease free for a minimum of 3 years?\n\n(N) 4. Did the patient have prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowable)?\n\n(N) 5. Did the patient have prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields?\n\n(N) 6. Did the patient have prior cancer-related surgeries of curative intent of the head and neck excluding superficial removal of cutaneous skin malignancies?\n\n(N) 7. Does the patient have any co-morbid condition or concern that may interfere with follow up per experimental arm?\n\n(N) 8. Does the patient have an active drug or alcohol dependency that in the opinion of the investigator would limit compliance with study requirements?\n\n(N) 9. Is the patient pregnant or nursing (an exception will be made for nursing patients that are not receiving chemotherapy)?",{"count":618,"type":22},132,[26],"Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have very good outcomes. Patients' treatment responses depend more on their individual cancer characteristics and personal risk factors than on the specific type of treatment they receive. However, the different treatments used for this cancer can cause significant side effects. Because outcomes are often favorable regardless of treatment type, reducing treatment-related side effects should be a priority when choosing care.\n\nStudies have reported that lowering radiation doses for some patients can reduce side effects while still effectively controlling the cancer.\n\nPatients with this type of head and neck cancer typically receive either surgery or radiation as their first treatment.\n\nFor patients who receive surgery first, radiation to the surgical area and nearby neck lymph nodes is often recommended afterward. In these patients, the study will test whether lowering the radiation dose to low-risk lymph nodes on the side of the neck opposite the tumor can reduce side effects while still effectively controlling the cancer (Method A).\n\nFor patients who receive radiation as their first treatment, the study will test one or both of two radiation approaches aimed at reducing both short-term and long-term side effects. These approaches include reduced lymph node radiation (Method A, described above) and a tumor dose reduction approach (Method B), which lowers the radiation dose delivered directly to the tumor.\n\nInformation such as tumor size, the number of cancerous or suspicious lymph nodes, and risk factors like smoking history will be used to determine which patients may be eligible for reduced lymph node radiation (Method A), reduced tumor radiation (Method B), or both. Patients who may qualify for tumor dose reduction (Method B), either alone or combined with Method A, will need an additional blood test called a circulating tumor DNA (ctDNA) test to determine eligibility.\n\nThe ctDNA test measures small amounts of tumor-related DNA in the blood, which are often elevated at the time of diagnosis. Studies have shown that cancer is more likely to return when ctDNA levels remain positive after treatment. This study will evaluate whether ctDNA levels measured before and during treatment can help identify patients who can safely receive lower radiation doses to the tumor (Method B).\n\nOverall, this study aims to safely evaluate two radiation de-escalation approaches in order to lessen short- and long-term side effects while maintaining excellent cancer control.",[29,622,30,514,623,624,33,625,626,627,628,322,629,630],"Head and Neck Squamous Cell Cancer","Oropharyngeal Squamous Cell Carcinoma (OPSCC)","Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma (SCC)","Oropharyngeal Squamous Cell Carcinoma (OPSCCA)","Oropharyngeal Cancer","Oropharyngeal Squamous Cell Cancer","HPV (Human Papillomavirus)-Associated Carcinoma","HPV 16 Positive Oropharyngeal Tumors (OPC)",[632,29,633,634,635,636,637,638,639],"Transoral Robotic Surgery (TORS)","Oropharynx Cancer","HPV p16 Oropharynx Cancer","Proton Therapy","Photon Therapy","Radiation Therapy","ctDNA","P16 positive","2026-02-10",{"date":642,"type":53},"2026-02-18",{"date":605,"type":22},{"date":607,"type":22},{"name":646,"class":100},"University of Maryland, Baltimore",{"id":648,"slug":649,"hasResults":12,"nctId":650,"briefTitle":651,"officialTitle":651,"acronym":652,"eligibilityCriteria":653,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":654,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":655,"conditions":656,"keywords":657,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":665,"locationsCount":61},"100619334","dual-energy-ct-vs-mri-in-the-evaluation-of-squamous-cell-carcinomas-of-the-oral-cavity-and-oropharynx-100619334","NCT07343271","Dual-energy CT vs. MRI in the Evaluation of Squamous Cell Carcinomas of the Oral Cavity and Oropharynx","DECT-CEco","Inclusion Criteria:\n\n* Adult patient (≥18 years)\n* presenting with oral or oropharyngeal squamous cell carcinoma proven by histopathological analysis of a biopsy\n* having undergone a clinical examination with nasofibroscopy by an ENT surgeon specializing in cancer surgery\n* a contrast-enhanced cervicofacial MRI\n* and a contrast-enhanced cervicofacial DECT with BOLT maneuver.\n\nExclusion Criteria:\n\n* A lesion other than oral or oropharyngeal squamous cell carcinoma\n* A labial location\n* A contraindication to performing one or both of the imaging examinations.",{"count":5,"type":22},"The diagnostic and pre-therapeutic assessment of squamous cell carcinomas requires a neck and chest CT scan and a neck and facial MRI, which is the most effective examination, to establish the TNM stage of the tumor. However, obtaining this complete assessment can delay treatment. Confirmation of the non-inferiority of 40keV dual-energy CT in BOLT compared to MRI would spare the patient an additional MRI examination, speed up the pre-treatment assessment, reduce the loss of opportunity due to delayed treatment, and free up MRI imaging slots, which are still insufficient in the region.",[36,33],[36,33,658],"TNM stage of the tumor","2026-01-06",{"date":379,"type":53},{"date":662,"type":53},"2025-07-11",{"date":664,"type":22},"2026-07-11",{"name":666,"class":100},"University Hospital, Strasbourg, France",{"id":668,"slug":669,"hasResults":12,"nctId":670,"briefTitle":671,"officialTitle":672,"acronym":673,"eligibilityCriteria":674,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":675,"targetDuration":4,"studyType":23,"phases":677,"briefSummary":679,"conditions":680,"keywords":682,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":688,"lastUpdatePostDateStruct":689,"startDateStruct":691,"completionDateStruct":693,"leadSponsor":695,"locationsCount":697},"100464886","phase-3-personalized-elective-neck-irradiation-guided-by-sentinel-lymph-node-biopsy-in-larynx-and-pharynx-cancer-the-primo-study-100464886","NCT05333523","Personalized Elective Neck Irradiation Guided by Sentinel Lymph Node Biopsy in Larynx and Pharynx Cancer. The PRIMO Study.","Personalized Elective Neck Irradiation Guided by Sentinel Lymph Node Biopsy in Patients With Squamous Cell Carcinoma of the Oropharynx, Larynx or Hypopharynx With a Clinically Negative Neck: (Chemo)Radiotherapy to the PRIMary Tumor Only. The PRIMO Study.","PRIMO","Inclusion Criteria:\n\n* Adult patients (≥18 years) with newly diagnosed cT1-4N0-2bM0 squamous cell carcinoma of the oropharynx (HPV-), larynx or hypopharynx, or cT1-4N0-1M0 oropharynx (HPV+) (AJCC TNM 8)\n* Histopathological diagnosis of squamous cell carcinoma.\n* Adequate staging of the neck including CT or MRI, and 18F-FDG-PET demonstrating no contralateral lymph node metastases.\n* Recommendation for curative intent external beam (chemo)radiotherapy made by a multidisciplinary head and neck oncology team (in case of chemoradiotherapy, only patients receiving concomitant platinum-based regimen are eligible).\n* Bilateral ENI is indicated according to Dutch consensus guidelines (LPHHRT) (see Appendix 13.1).\n* Procedures for SLNB (i.e. tumor accessible for tracer injection, imaging and surgery under general anesthesia) are deemed feasible by the head and neck surgeon.\n\nExclusion Criteria:\n\n* Recurrent disease or previous anticancer treatment to the head and neck area (e.g. radical attempt or tumor reductive surgery, neck dissection, neo-adjuvant chemotherapy or radiotherapy) except for endoscopic glottic laser micro surgery.\n* Well lateralized oropharyngeal cancers and early stage laryngeal cancers requiring no or unilateral ENI according to Dutch consensus guidelines (LPHHRT)\n* Patients receiving concomitant non-platinum-based systemic agents (e.g. cetuximab).\n* Patients that qualify for proton therapy and want to be treated accordingly.\n* Compromised airway or tracheostomy.\n* Any active invasive malignancy within the last 3 years except for early stage basal\u002Fsquamous cell carcinoma of the skin and incidental finding of stage T1N0M0 prostate cancer.\n* Any somatic, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.",{"count":676,"type":22},242,[678],"PHASE3","Rationale \\| Elective neck irradiation is performed in head and neck cancer patients treated with definitive (chemo)radiotherapy. The aim is to eradicate nodal metastases that are not detectable by pretreatment imaging techniques. It is conceivable that personalized neck irradiation can be performed guided by the results of sentinel lymph node biopsy. It is expected that elective neck irradiation can be omitted to one or both sides of the neck in 9 out of 10 patients with a clinically negative neck (cN0). For patients with clinically positive ipsilateral nodes (cN1-2b), it is expected that elective irradiation of the contralateral neck can be omitted in 7 out of 10 patients. This will enable better sparing of normal tissues from radiation and result in less permanent long-term radiation side effects with better quality of life.\n\nMethods\u002Fdesign \\| This is a multicenter randomized controlled trial aiming to compare safety and efficacy of treatment with sentinel lymph node biopsy guided neck irradiation versus standard bilateral elective neck irradiation in 242 patients with cN0-N2b squamous cell carcinoma of the oropharynx, larynx or hypopharynx for whom bilateral elective neck irradiation is indicated. Patients randomized to the experimental-arm will undergo sentinel lymph node biopsy. Based on the histopathologic status of the sentinel lymph nodes, patients will receive no elective neck irradiation (if no nodal metastases found at both sides of the neck), unilateral neck irradiation only (if no nodal metastases found at contralateral side of the neck only) or bilateral neck irradiation (if nodal metastases found at both sides of the neck). Patients randomized to the control arm will not undergo sentinel lymph node biopsy but will receive standard bilateral elective neck irradiation. The primary safety endpoint is the number of patients with recurrence in regional lymph nodes within 2 years after treatment. The primary efficacy endpoint is patient reported xerostomia-related quality of life at 6 months after treatment.\n\nDiscussion \\| If this trial demonstrates that the experimental treatment is non-inferior to the standard treatment in terms of regional recurrence and is superior in terms of xerostomia-related quality of life, this will become the new standard of care.",[148,681,33],"Hypopharynx Squamous Cell Carcinoma",[683,684,685,686,687],"Head and neck cancer","Squamous cell carcinoma","Sentinel lymph node biopsy","Elective neck irradiation","FDG-PET","2025-11-20",{"date":690,"type":53},"2025-11-24",{"date":692,"type":53},"2023-12-06",{"date":694,"type":22},"2029-12-01",{"name":696,"class":100},"Radboud University Medical Center",9,{"id":699,"slug":700,"hasResults":12,"nctId":701,"briefTitle":702,"officialTitle":703,"acronym":4,"eligibilityCriteria":704,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":705,"targetDuration":4,"studyType":23,"phases":707,"briefSummary":709,"conditions":710,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":711,"lastUpdatePostDateStruct":712,"startDateStruct":714,"completionDateStruct":716,"leadSponsor":717,"locationsCount":61},"100586409","early-phase-1-comparing-an-investigational-scan-f-18-naf-petct-to-standard-of-care-imaging-f-18-fdg-petct-for-evaluating-vascular-complications-in-patients-receiving-radiation-therapy-for-head-and-neck-cancer-100586409","NCT06914999","Comparing an Investigational Scan (F-18 NaF PET\u002FCT) to Standard of Care Imaging (F-18 FDG PET\u002FCT) for Evaluating Vascular Complications in Patients Receiving Radiation Therapy for Head and Neck Cancer","Assessment of Radiation-Induced Vascular Complications in Patients With Head and Neck Cancers With PET\u002FCT Imaging","Inclusion Criteria:\n\n* Males and females 18 years of age and older\n* Diagnosis of clinical stage III-IVb (American Joint Committee on Cancer \\[AJCC\\] 8th edition) squamous cell carcinoma of the oropharynx (human papillomavirus \\[HPV\\]-negative), larynx, or hypopharynx, or clinical stage I-III (AJCC 8th edition) HPV-associated squamous cell carcinoma of the oropharynx receiving curative-intent, organ preservation (non-surgical)\n* Treatment with concurrent chemoradiotherapy per institutional standard of care at the discretion of Medical Oncology. RT is delivered per institutional standard of care at the discretion of Radiation Oncology\n* Patients must give protocol-specific consent on an Institutional Review Board (IRB)-approved consent form prior to completion of protocol-specific testing\u002Fprocedures\n* Women are eligible to participate in the study if they meet one of the following criteria:\n\n  * Females of childbearing potential (FCBP) must have a negative pregnancy test at baseline and follow-up visit. Women of childbearing potential must undergo pregnancy testing during each study visit and agree to use at least one of the following methods of contraception throughout the study duration:\n\n    * Oral contraceptives, transdermal contraceptives, injectable or implantable methods, intrauterine devices, and\u002For vaginal ring\n    * Women who are postmenopausal (for at least one year), sterile, or hysterectomized;\n    * Women who have undergone tubal ligation will be required to undergo pregnancy testing during each study visit\n\nExclusion Criteria:\n\n* Adults who are unable to consent\n* Pregnant women\n* Prisoners\n* Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier (i.e., have residual toxicities \\> grade 1)\n* Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of the F-18 NaF for the pre-RT PET\u002FCT imaging\n* Patients planned to receive any immunotherapy agent during their radiotherapy or in the interval between radiotherapy and post-RT PET\u002FCT imaging\n* History of allergic reactions attributed to compounds of similar chemical or biological composition to F-18 NaF or other agents used in the study\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Significant cardiovascular disease (eg, myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to study entry; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association class 3 or 4 congestive heart failure; or uncontrolled grade \\>= 3 hypertension (diastolic blood pressure \\>= 100 mmHg or systolic blood pressure \\>= 160 mmHg) despite antihypertensive therapy",{"count":706,"type":22},20,[708],"EARLY_PHASE1","This early phase I trial compares sodium fluoride F-18 (F-18 NaF) positron emission tomography (PET)\u002Fcomputed tomography (CT) to the standard of care imaging scan (and fludeoxyglucose F-18 \\[F-18 FDG\\] PET\u002FCT) for assessing the effects radiation therapy has on the blood vessels in the neck in patients with head and neck cancers. For people with cancers in the head and neck, doctors often use radiation to target both the tumor and nearby glands. Radiation therapy to this region can affect the blood vessels in the neck that supply blood to the brain. F-18 NaF and F-18 FDG are contrast agents that can be used together with PET\u002FCT imaging to visualize areas inside the body. A PET scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. A CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET\u002FCT scans are hybrid scanners that combine both modalities into a single scan during the same examination. Imaging with F-18 NaF PET\u002FCT may be as effective or more effective than the standard F-18 FDG PET\u002FCT for assessing the effects radiation therapy has on blood vessels in the neck in patients with head and neck cancers.",[144,145,146,30,147,148,33,167,168,171,172,173,176,177,178,180],"2025-10-20",{"date":713,"type":53},"2025-10-22",{"date":715,"type":53},"2024-12-03",{"date":562,"type":22},{"name":477,"class":100}]