[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oropharyngeal-squamous-cell-carcinoma-opscc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oropharyngeal-squamous-cell-carcinoma-opscc":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100632415","phase-2-omission-of-postoperative-radiation-in-hpv-associated-oropharyngeal-cancer-using-cthpvdna-surveillance-operation-100632415",false,"NCT07513389","Omission of Postoperative Radiation in HPV-Associated Oropharyngeal Cancer Using ctHPVDNA Surveillance (OPERATION)","Omission of Immediate Postoperative Radiation in Patients With Intermediate Pathological Risk Features and Negative Two-Week Post-Operative ctHPVDNA (OPERATION Trial)","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form.\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Male or female, ≥ 18 years of age (no upper age limit).\n* Biopsy proven squamous cell carcinoma.\n* p16 positive (diffuse ≥ 70% tumor cell expression, with at least moderate (2\u002F3+ staining intensity).\n* NavDx positive, HPV16 TTMV only.\n* AJCC 8th edition cT0-2 N1 M0.\n* Well lateralized tonsil (\\>1 cm from midline, tonsil, base of tongue, glossotonsillar sulcus primary tumors.\n* ≤ 2 lymph nodes, each ≤ 3cm, -OR- 1 lymph node \\>3 but \\\u003C 6 cm.\n* ≤10 pack-years of cigarette smoking or no cigarette smoking for ≥ 5 years (regardless of pack years).\n* Anatomically (e.g. adequate exposure) and physically amenable to TORS per the judgement of the operating surgeon.\n* Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to surgery; at a minimum CT imaging of the chest. PET\u002FCT is acceptable.\n* ECOG Performance Status 0-1.\n* CBC with differential obtained within 8 weeks prior to surgery, with adequate bone marrow function defined as follows:\n\n  * Platelets ≥ 100,000 cells\u002Fmm3\n  * Hemoglobin ≥ 9.0 g\u002Fdl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g\u002Fdl is acceptable. Transfusion must be completed within 2 to 4 weeks prior to enrollment.)\n* Adequate renal and hepatic function within 8 weeks prior to surgery, defined as follows:\n\n  * Serum creatinine \\\u003C 2.0 mg\u002Fdl.\n  * Total bilirubin ≤ 1.5 x the institutional ULN.\n* Negative pregnancy test within 2 weeks prior to surgery for women of childbearing potential.\n* Eligible for platinum chemotherapy. Chemotherapy drugs allowed: cisplatin, carboplatin\u002Fpaclitaxel, carboplatin\u002Fabraxane, per treating physician (cisplatin preferred, 2nd preference carboplatin\u002Fpaclitaxel or carboplatin\u002Fabraxane).\n* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional year after surgery per MD discretion. Acceptable forms of birth control include hormonal contraceptives (such as birth control pills, skin patch, vaginal ring, injection, and\u002For implant), intrauterine devices (IUDs), and barrier devices (such as condoms, diaphragm, cervical cap, and sponge).\n\nExclusion Criteria:\n\n* Prior history of surgery to the head and neck that in the opinion of the investigators would modify prognostic significance of pathology results.\n* Prior history of radiation therapy to the head and neck, with the exception of skin cancer treated with a small (≤ 9cm3) field with 6 - 9 MeV electron beam or 50 - 250 kVp photon beam.\n* Prior history within 5 years of cancer with the exception of:\n\n  * Basal cell carcinoma of the skin\n  * Squamous cell carcinoma of the skin, stage 1-2\n  * Prostate cancer without distant metastases (stage M0)\n  * Thyroid cancer without distant metastases (stage M0)\n* Prior history of squamous cell carcinoma of a mucosal site in the head or neck treated with surgery alone.\n* Currently taking Disease Modifying Rheumatoid Drugs (DMRDs) or immunosuppressive medication, for example as for organ transplant or multiple sclerosis.\n* Current smoker or tobacco user.\n\n  * Severe, active co-morbidity, defined as one or more of the following:\n  * Unstable angina and\u002For congestive heart failure requiring inpatient 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 (COPD) 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.\n\n    \\--- Note, however, coagulation parameters are not required for entry into this protocol.\n  * Evidence of active systemic lupus or scleroderma.\n  * Psoriatic arthritis.\n* 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.\n\n  \\-- Note: HIV testing at the time of enrollment is not required.\n* Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for the immediate post-op period (1-2 weeks). Females will be determined to be not of child-bearing potential with a history of hysterectomy or with postmenopausal status of \\>12 months.\n* Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study, starting one month prior to screening and for one year after surgery per MD discretion.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.","ALL","18 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This single-arm Phase II trial evaluates whether omission of postoperative radiotherapy is feasible and oncologically safe in select patients with HPV-associated oropharyngeal squamous cell carcinoma (HPV-OPSCC). Eligible patients undergo transoral robotic surgery (TORS) and are observed without adjuvant radiation if they demonstrate low or intermediate pathological risk features and have negative circulating tumor HPV DNA (ctHPVDNA) two weeks post-operatively. Patients are followed with standard clinical surveillance combined with serial ctHPVDNA testing (NavDx®) to facilitate early detection of recurrence and prompt salvage therapy as needed.",[26,27,28],"Squamous Cell Carcinoma","Human Papilloma Virus (HPV)","Oropharyngeal Squamous Cell Carcinoma (OPSCC)","RECRUITING","2026-06-29",{"date":32,"type":33},"2026-06-30","ACTUAL",{"date":35,"type":20},"2026-10-01",{"date":37,"type":20},"2030-07-01",{"name":39,"class":40},"Medical University of South Carolina","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":67,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"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":50,"type":20},132,[23],"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.",[54,55,56,57,28,58,59,60,61,62,63,64,65,66],"Head and Neck Cancer","Head and Neck Squamous Cell Cancer","Head and Neck Squamous Cell Carcinoma","Oropharyngeal Carcinoma","Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma (SCC)","Oropharyngeal Squamous Cell Carcinoma (OPSCCA)","Oropharyngeal Cancer","Oropharyngeal Squamous Cell Cancer","HPV Positive Oropharyngeal Squamous Cell Carcinoma","HPV (Human Papillomavirus)-Associated Carcinoma","HPV 16 Positive Oropharyngeal Tumors (OPC)",[68,54,69,70,71,72,73,74,75],"Transoral Robotic Surgery (TORS)","Oropharynx Cancer","HPV p16 Oropharynx Cancer","Proton Therapy","Photon Therapy","Radiation Therapy","ctDNA","P16 positive","NOT_YET_RECRUITING","2026-02-10",{"date":79,"type":33},"2026-02-18",{"date":81,"type":20},"2026-05",{"date":83,"type":20},"2033-05",{"name":85,"class":40},"University of Maryland, Baltimore"]