[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clinical-stage-i-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clinical-stage-i-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc-v8":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,80,102,125,147,180,201,223],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"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",false,"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.","ALL","18 Years",{"count":19,"type":20},98,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","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.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66],"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","Head and Neck Squamous Cell Carcinoma","Hypopharyngeal Squamous Cell Carcinoma","Laryngeal Squamous Cell Carcinoma","Nasopharyngeal Squamous Cell Carcinoma","Oral Cavity Squamous Cell Carcinoma","Oropharyngeal 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","RECRUITING","2026-06-22",{"date":70,"type":71},"2026-06-25","ACTUAL",{"date":73,"type":71},"2025-06-23",{"date":75,"type":20},"2027-01-01",{"name":77,"class":78},"NRG Oncology","OTHER",153,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100606649","phase-2-evaluating-a-decreased-dose-of-radiation-therapy-to-the-elective-neck-for-the-treatment-of-hpv-related-oropharyngeal-cancer-enlight-trial-100606649","NCT07178301","Evaluating a Decreased Dose of Radiation Therapy to the Elective Neck for the Treatment of HPV-Related Oropharyngeal Cancer, ENLIGHT Trial","Elective Neck Dosing in Low Risk Oropharyngeal Human Papillomavirus-Related Cancer Treatment (ENLIGHT): A Single Arm Prospective Phase II Assessing 30 Gy Elective Neck Dose","Inclusion Criteria:\n\n* 3.1.1 Patients must have a histologically confirmed HPV-related OPSCC, confirmed by HPV insitu hybridization.\n* 3.1.2 Patients must not have received prior treatment (i.e., no induction chemotherapy).\n* 3.1.3 Patients must have evaluable disease (per RECIST v1.1 response criteria). See Section 6.\n* 3.3 for the evaluation of measurable disease.\n* 3.1.4 Patients must be age ≥ 18 years.\n* 3.1.5 Patients must have AJCC 8 th edition Stage I-II disease, as defined by a T-classification of T1-3, and N-classification of N1-2, without metastases (M0), as defined by physical examination (including nasopharyngolaryngoscopy) and positron emission tomography (PET)\n* 3.1.6 Patient must receive a staging PET scan prior to registration on study.\n* 3.1.7 Patients must exhibit an ECOG performance status of 0-1. Please refer to Appendix A ECOG Performance Status Scale.\n* 3.1.8 Patients may be planned to undergo RT alone or RT with concurrent chemotherapy, with chemotherapy managed at the discretion of the treating medical oncologist per standard of care.\n* 3.1.9 RT is known to be teratogenic to a developing human fetus. For this reason, patients of child-bearing potential (POCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from time of informed consent, for the duration of study participation (while actively receiving RT. Should a patient become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. NOTE: A POCBP is any patient (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: • Has not undergone a hysterectomy or bilateral oophorectomy • Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months)\n* 3.1.10 POCBP must have a negative pregnancy test prior to CT simulation or sign the Department of Radiation Oncology's pregnancy testing declination form. Note: the timing of the pregnancy test\u002Fdeclination form will follow the policy of the Department of Radiology and Oncology, which requires completion of pregnancy testing or signed pregnancy declination prior to CT simulation.\n* 3.1.11 Patients must have the ability to understand and the willingness to sign a written informed consent document prior to registration.\n\nExclusion Criteria:\n\n* 3.2.1 Patients with cT4, cN3, or cM1 disease by AJCC 8 th edition.\n* 3.2.2 Patients who have had prior RT to the head\u002Fneck region that would result in overlap of RT fields. 3.2.3 Patients who have had prior major surgery to the head\u002Fneck region that could disrupt lymphatic flow.\n* 3.2.4 Patients who have an uncontrolled intercurrent illness that would interfere with the receipt of RT including, but not limited to any of the following, are not eligible: • Uncontrolled connective tissue disorders (e.g. lupus, scleroderma) given potential for this to interfere with RT • Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements • Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints",{"count":88,"type":20},100,[23],"This clinical trial evaluates how decreasing the dose of radiation to the elective neck (areas of lymph nodes not directly involved in the cancer) impacts treatment outcomes in patients with human papillomavirus (HPV)-related oropharyngeal cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Radiation therapy plays an important role in the treatment of HPV-related oropharyngeal cancer, but it also causes significant toxicities. Given the significant toxicities associated with treatment, and the excellent outcomes of HPV-related oropharyngeal cancer, researchers are attempting to identify methods to de-escalate treatment for HPV-related oropharyngeal cancer in an effort to maintain excellent treatment outcomes while reducing the risk of toxicities. Reducing the dose of radiation therapy to the lymph nodes in the neck that aren't directly involved in the cancer may improve patient quality of life while still maintaining excellent rates of cure of disease.",[26,27],"2026-06-04",{"date":94,"type":71},"2026-06-08",{"date":96,"type":71},"2025-12-05",{"date":98,"type":20},"2031-03-20",{"name":100,"class":78},"Northwestern University",2,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100480825","phase-2-de-escalated-adjuvant-and-definitive-radiation-therapy-informed-by-dart-20-cthpv-dna-100480825","NCT05541016","De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA","DART 2.0: ctHPV-DNA Informed De-Escalated Adjuvant and Definitive Radiation Therapy","Inclusion Criteria:\n\n* PRE-REGISTRATION (optional): Provide written informed consent\n* Age \\>= 18 years\n* Histological confirmation of squamous cell carcinoma originating from or suspected to be originating from the oropharynx\n* Plan for gross total surgical resection via trans oral surgery with curative intent and at least unilateral neck dissection OR chemoradiotherapy with cisplatin. Note: The patient must be cisplatin eligible even if an alternate is used due to drug shortage\n* Absence of distant metastases on standard diagnostic work-up =\\\u003C 16 weeks prior to registration. (Chest CT or PET\u002FCT)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\\\u003C 1\n* Negative pregnancy test done =\\\u003C 7 days prior to registration, for women of childbearing potential only\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Provide written informed consent\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* Willing to provide blood samples for correlative research purposes, including anonymous shipment of samples to for NavDx testing\n\nExclusion Criteria:\n\n* Any of the following:\n\n  * Pregnant women\n  * Nursing women\n  * Men or women of childbearing potential who are unwilling to employ adequate contraception\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Immunocompromised patients and patients known to be human immunodeficiency virus (HIV)+\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* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Other active malignancy =\\\u003C 5 years prior to registration. EXCEPTIONS: Nonmelanotic skin cancer or carcinoma-in-situ of the cervix, or prostate or localized endometrioid endometrial cancer. NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer\n* Prior history of radiation therapy to the affected site\n* Prior systemic chemotherapy in the last 5 years\n* Contraindication to radiation therapy as determined by the treating team\n* History of allergic reaction to docetaxel\n* Receiving any medications or substances which in the opinion of the investigators would interfere with treatment. Examples could include strong inhibitors of cytochrome P450 3A4 (CYP3A4) at oncologist discretion\n* Severe pre-existing ototoxicity or neuropathy that would, in the opinion of the investigator, preclude the use of cisplatin chemotherapy\n* cT4 primary tumor\n\n  * NOTE: Patients with no intermediate risk factors after surgery, low risk patients, as defined by T1, T2, tumors with lymph node less than 3cm, no intermediate or high-risk factors such as lymphatic invasion (LVSI), extranodal extension (ENE), perineural invasion (PNI), positive margin, will be withdrawn from study and be observed per current clinical standard of care. Patients found to be both HPV negative and p16 negative will be withdrawn from study.\n  * Patients found to have HPV non 16 type, or HPV detectability in blood less than \\\u003C20tumor tissue modified viral (TTMV) will not be candidates for de-escalation in Groups 1 and 2 and will be treated in Group 3 unless otherwise meeting criteria for low risk. They will receive 60 Gy +\u002F- cisplatin or acceptable alternate regimen when drug shortages of cisplatin exist. If treated primarily with chemoradiation (chemoRT) (Group 4), these patients will not be candidates for de-escalation if TTMV is \\\u003C 50 TTMV but can remain on study receiving 70 Gy with all corresponding correlative studies applying\n  * Patients with unknown (radiologic\u002Fclinically occult) primaries but neck adenopathy suspected to be HPV associated oropharyngeal carcinoma can be registered to go on study for Groups 1-3. Should after primary resection, no primary tumor be identified, the patient will be withdrawn from study and be treated per institutional standard of care. Group 4 patients must have an identifiable (clinically or radiologically apparent) primary tumor\n  * All treatment primarily, including surgery and chemotherapy will be performed at the enrolling institution",{"count":110,"type":20},455,[23],"This phase II trial examines the use of blood-based biomarkers is to help inform decision making for treatment and radiation therapy for patients with human papillomavirus (HPV) positive oropharyngeal squamous cell cancers. The standard treatments for head and neck cancers are radiation therapy with chemotherapy or surgery potentially followed by radiation therapy with or without chemotherapy. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving chemotherapy along with radiation may kill more tumor cells. However, the cancer can recur or can spread to other parts of the body and all treatments can be associated with side effects. The purpose of this study is to evaluate a blood-based biomarker, using the NavDx testing device, for head and neck cancers in order to see if it can help improve selection of the intensity of treatment in order to best balance the side effects of treatment with the goal of decreasing cancer recurrence. This test could aid in early detection of recurrence and salvage therapy.",[26,27,28,114,44,50,56],"Human Papillomavirus-Related Oropharyngeal Squamous Cell Carcinoma","2026-05-08",{"date":117,"type":71},"2026-05-12",{"date":119,"type":71},"2023-02-21",{"date":121,"type":20},"2029-08-01",{"name":123,"class":78},"Mayo Clinic",3,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":21,"phases":134,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":4},"100626903","phase-3-comparing-radiation-plus-cetuximab-to-radiation-plus-chemotherapy-in-people-with-head-and-neck-cancer-who-cannot-receive-cisplatin-100626903","NCT07441681","Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Head and Neck Cancer Who Cannot Receive Cisplatin","Radiotherapy With Concurrent Cetuximab vs. Carboplatin and Paclitaxel in Patients With Stage III-IVB Head and Neck Cancer With a Contraindication to Cisplatin: A Pragmatic Phase III Randomized Trial","Inclusion Criteria:\n\n* Patients must have pathologically confirmed, previously untreated, unresected squamous cell carcinoma of the larynx, hypopharynx, oropharynx, or oral cavity\n* Local evaluation of p16 status is required for all oropharynx patients prior to registration\n* Local evaluation of p16 status is recommended for non-oropharynx patients prior to registration\n* Locoregionally advanced head and neck squamous cell carcinoma (HNSCC) defined as:\n\n  * Non-oropharynx and p16-negative oropharynx cancer: American Joint Commission on Cancer (AJCC) 8th edition stage III-IVB\n\n    * Laryngeal, Hypopharyngeal, Oral Cavity, and p16-Negative Oropharyngeal Primaries:\n\n      * AJCC 8th Edition TNM: T3-4b N0 M0 AJCC 8th Edition Stage: III-IVB\n      * AJCC 8th Edition TNM: T1-4b N1-3 M0 AJCC 8th Edition Stage: III-IVB\n  * p16-positive oropharynx cancer: AJCC 8th edition stage III and selected stage I-II based on smoking status in pack-years\n\n    * Eligible p16-Positive Oropharyngeal Primaries\n\n      * AJCC 8th Edition TNM: T1-2 N1 M0 AJCC 8th Edition Stage: I Pack-Years: \\> 10\n      * AJCC 8th Edition TNM: T1-2 N2 M0 AJCC 8th Edition Stage: II Pack-Years: any\n      * AJCC 8th Edition TNM: T3 N0-1 M0 AJCC 8th Edition Stage: II Pack-Years: \\> 10\n      * AJCC 8th Edition TNM: T3 N2 M0 AJCC 8th Edition Stage: II Pack-Years: any\n      * AJCC 8th Edition TNM: T1-3 N3 M0 AJCC 8th Edition Stage: III Pack-Years: any\n      * AJCC 8th Edition TNM: T4 N0-3 M0 AJCC 8th Edition Stage: III Pack-Years: any\n\n        * Note: Number of pack-years = \\[Frequency of smoking (number of cigarettes per day) × duration of cigarette smoking (years)\\] \u002F 20\n        * Note: Cigar and pipe tobacco consumption is not included in calculating the lifetime pack-years. Marijuana consumption is likewise not considered in this calculation. There is also no clear scientific evidence regarding the role of chewing tobacco-containing products in oropharyngeal cancer, although this is possibly more concerning given the proximity of the oral cavity and oropharynx. In any case, investigators should not count use of non-cigarette tobacco products in the pack-years calculation\n* The following are required prior to registration:\n\n  * Imaging of the head and neck with a neck CT or MRI (with contrast, unless contraindicated) or PET\u002FCT which includes diagnostic-quality CT of the neck (with contrast, unless contraindicated)\n  * Chest imaging: Chest CT (with contrast, unless contraindicated) or PET\u002FCT\n* Age ≥ 18\n* Complete the online tool at www.nrgoncology.org prior to registration and record the (modified) Charleston Comorbidity Index (CCI), Head and Neck Cancer Intergroup (HNCIG) omega, and G-8 scores on the registration form in Oncology Patient Enrollment Network (OPEN)\n* Patients must have a contraindication to cisplatin as defined in the following bullet points:\n\n  * Absolute or relative contraindication to cisplatin, defined as ONE OR MORE of the following prior to registration:\n\n    * Creatinine clearance (CrCl) \\\u003C 60 mL\u002Fmin by the Cockroft-Gault formula\n    * Pre-existing peripheral (sensory or motor) neuropathy grade ≥ 2 (per Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v\\] 5.0)\n    * History of hearing loss, defined as either:\n\n      * Existing need of a hearing aid OR\n      * ≥ 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated OR\n  * age ≥ 70 with Head and Neck Cancer Intergroup (HNCIG) omega score \\\u003C 0.80 prior to registration OR\n  * Age \\\u003C 70 with ALL of the following conditions prior to registration (see Appendix II for calculation instructions):\n\n    * HNCIG omega score \\\u003C 0.80\n    * (Modified) Charlson Comorbidity Index (CCI) ≥ 1\n    * G-8 score ≤ 14\n* Not pregnant and not nursing\n* Participants must be able to safely receive the radiation and drug regimens per current Food and Drug Administration (FDA)-approved package insert(s), treating investigator's discretion, and institutional guidelines\n* No prior systemic therapy for the study cancer; note that prior systemic therapy for a different cancer is allowable\n* No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n* No prior surgery for the study cancer",{"count":133,"type":20},454,[135],"PHASE3","This phase III trial compares cetuxumab to chemotherapy, carboplatin and paclitaxel, with intensity modulated radiation therapy for the treatment of patients with head and neck cancer who are unable to receive cisplatin. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Intensity modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. It is not yet know if cetxiumab or chemotherapy, with intensity modulated radiation therapy works best for the treatment of patients with head and neck cancer who are unable to receive cisplatin.",[26,27,28,29,52,53,54,56,57,58,59,61,62,63,64,65],"NOT_YET_RECRUITING","2026-04-28",{"date":141,"type":71},"2026-05-04",{"date":143,"type":20},"2027-01-06",{"date":145,"type":20},"2035-11-30",{"name":77,"class":78},{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":156,"phases":4,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":179},"100286553","blood-tests-and-questionnaires-in-studying-adherence-to-preventative-swallowing-exercises-in-participants-with-metastatic-head-and-neck-cancer-100286553","NCT03010150","Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastatic Head and Neck Cancer","Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer","Inclusion Criteria:\n\n* Are dispositioned to receive radiation with curative intent for nasopharyngeal, oropharyngeal, hypopharyngeal, laryngeal, or an unknown primary cancer with cervical metastases\n* Are stage II-IVb for non- human papillomavirus (HPV)- related oropharyngeal cancer\n* Have HPV- related oropharynx cancer that is T1, have nodal involvement with no distant metastasis or have HPV- related oropharynx cancer that is at least T2 with no distant metastasis\n* Are stage II-IVb for laryngeal cancer\n* Are stage I-IVb for hypopharyngeal\n* Are stage I-IVb for nasopharyngeal cancer\n* Have stage I-III unknown primary cancer with cervical\n\nExclusion Criteria:\n\n* Have other cancer diagnoses, except non-melanoma skin cancer\n* Had treatment for previous head and neck cancer or radiation to the head and neck\n* Have a history of previous head and neck surgery (excluding biopsy and\u002For tonsillectomy and\u002For tracheotomy)\n* Have a current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g., dysphagia due to underlying neurogenic disorder)",{"count":155,"type":20},471,"OBSERVATIONAL","This trial uses blood tests and questionnaires to study how well participants with head and neck cancer that has spread to other places in the body adhere to swallowing exercises to prevent future disease. Using blood tests to study cytokines (proteins related to the immune system) may help doctors learn if certain levels of cytokines affect whether or not side effects occur and if they put participants at risk for future disease. Questionnaires may help doctors learn about the reasons head and neck cancer participants may or may not follow the swallowing exercises that they are asked to perform after receiving radiation treatments.",[159,26,27,28,160,161,162,163,164,40,43,46,47,49,50,52,53,55,56,165,166,167,168,57,58,60,61,62,63,169,65],"Carcinoma of Unknown Primary","Metastatic Head and Neck Carcinoma","Metastatic Malignant Neoplasm in the Uterine Cervix","Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Stage IV Hypopharyngeal Carcinoma AJCC v8","Stage IV Laryngeal Cancer AJCC v8","Stage IV Nasopharyngeal Carcinoma AJCC v8","Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVB Nasopharyngeal Carcinoma AJCC v8","2026-04-10",{"date":172,"type":71},"2026-04-15",{"date":174,"type":71},"2016-12-29",{"date":176,"type":20},"2028-12-31",{"name":178,"class":78},"M.D. Anderson Cancer Center",1,{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":21,"phases":189,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":179},"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":188,"type":20},45,[23],"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.",[26,27,34],"2026-03-20",{"date":194,"type":71},"2026-03-24",{"date":196,"type":71},"2024-03-21",{"date":198,"type":20},"2026-12-31",{"name":200,"class":78},"Ohio State University Comprehensive Cancer Center",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":21,"phases":210,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":179},"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":209,"type":20},20,[211],"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.",[26,27,28,29,30,31,34,52,53,56,57,58,61,62,63,65],"2025-10-20",{"date":216,"type":71},"2025-10-22",{"date":218,"type":71},"2024-12-03",{"date":220,"type":20},"2027-08-31",{"name":222,"class":78},"Emory University",{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":229,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":21,"phases":232,"briefSummary":233,"conditions":234,"keywords":241,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":101},"100431631","phase-2-risk-adapted-therapy-in-hpv-oropharyngeal-cancer-using-circulating-tumor-cthpv-dna-profile---the-react-study-100431631","NCT04900623","Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study","Inclusion Criteria:\n\n* Participants must meet the following eligibility criteria at the time of screening to be eligible to participate in the study:\n* Subject must have histologically or cytologically confirmed, stage I, II, or III (N3 disease excluded), HPV associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma, as defined by 2017 American Joint Committee on Cancer (AJCC), 8th edition staging.\n\n  \\-- Patients with HPV-associated disease of unknown primary (cT0) are eligible\n* HPV status should be confirmed on tissue biopsy or cytologic sample by any of the following:\n\n  * Immunohistochemical staining for p16 with ≥70% expression\n  * Confirmatory DNA testing (PCR or ISH) for high-risk subtype\n* Willing to provide blood and tissue from a diagnostic biopsy and blood samples before, during, and after treatment.\n* Detectable HPV ctDNA blood sample at baseline, prior to treatment, using the NavDx® assay that detects HPV subtype 16\n* Age 22 years or older\n* ECOG performance status ≤ 2\n* Participants should have adequate organ and marrow function if they are to receive chemotherapy (cisplatin, or carboplatin and paclitaxel) with radiation concurrently as determined by standard institutional guidelines and investigator preference (parameters suggested below).\n\n  * absolute neutrophil count (ANC) ≥ 1000\n  * platelet count ≥ 100,000\n  * total bilirubin of 1.5 or less\n  * creatinine of 1.6 or less (or a CrCl ≥50 mL\u002Fmin) per institutional standards.\n* Planning to receive non-surgical management for HPV+ oropharyngeal cancer\n* Ability to understand and the willingness to sign a written informed consent document.\n* Women 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 (chemo)radiation therapy. \"Women of childbearing potential (WOCBP)\" is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level above 40 mIU\u002FmL.\n* Men who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 1 month after treatment. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception.\n\nExclusion Criteria:\n\n* Patients with AJCC 2017 8th edition stage IVC (metastatic) disease; or patients with fixed cervical nodal disease suggesting extranodal extension or N3 disease as suggested by lymph nodes measuring \\>6 cm.\n* Subject who has had prior radiation and\u002For chemotherapy for head and neck cancer.\n* Any history of oncologic surgical resection (transoral robotic surgery, TORS) or oncologic neck dissection prior to undergoing definitive RT or chemoradiation. Note: prior tonsillectomy as part of identification of the primary tumor site or biopsy and excisional nodal biopsy is\u002Fare acceptable provided the patient would be standardly treated to definitive treatment doses of therapy off protocol. Patients with HPV-associated unknown primary should not have undergone a neck dissection to be eligible.\n* Undetectable baseline HPV ctDNA result by NavDx® testing or detectable baseline HPV ctDNA result for subtypes 18, 31, 33, or 35.\n* Pregnant or lactating women.\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 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 chance3 of recurrence is thought to be low.","22 Years",{"count":231,"type":20},145,[23],"This research is being conducted to understand if treatment can be tailored for participants with HPV-related oropharynx cancers using both clinical features (stage of the tumor, smoking status) combined with an investigational HPV blood test.\n\nThe names of the test and treatments involved in this study are:\n\n* NavDx® HPV ctDNA testing (HPV blood test)\n* Radiation therapy\n* Chemotherapy: Cisplatin, or Carboplatin and Paclitaxel (not all participants receive any or all of these agents)",[235,236,237,238,28,164,27,163,26,162,239,240],"HPV-Associated Oropharyngeal Squamous Cell Carcinoma","HPV Positive Oropharyngeal Squamous Cell Carcinoma","HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Stage","HPV-Related Squamous Cell Carcinoma","HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical Stage","HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Pathologic Stage",[235,236,240,239,162,26,163,27,164,28],"2025-07-28",{"date":244,"type":71},"2025-07-30",{"date":246,"type":71},"2021-07-02",{"date":248,"type":20},"2032-06-01",{"name":250,"class":78},"Jonathan Schoenfeld, MD, MPH"]