[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pathologic-stage-iii-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:pathologic-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc-v8":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,68],{"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":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100286553","blood-tests-and-questionnaires-in-studying-adherence-to-preventative-swallowing-exercises-in-participants-with-metastatic-head-and-neck-cancer-100286553",false,"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)","ALL","18 Years",{"count":19,"type":20},471,"ESTIMATED","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.",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54],"Carcinoma of Unknown Primary","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","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 I Hypopharyngeal Carcinoma AJCC v8","Stage I Nasopharyngeal Carcinoma AJCC v8","Stage II Hypopharyngeal Carcinoma AJCC v8","Stage II Laryngeal Cancer AJCC v8","Stage II Nasopharyngeal Carcinoma AJCC v8","Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage III Hypopharyngeal Carcinoma AJCC v8","Stage III Laryngeal Cancer AJCC v8","Stage III Nasopharyngeal Carcinoma AJCC v8","Stage III Oropharyngeal (p16-Negative) 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 IVA Hypopharyngeal Carcinoma AJCC v8","Stage IVA Laryngeal 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 Nasopharyngeal Carcinoma AJCC v8","Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8","RECRUITING","2026-04-10",{"date":58,"type":59},"2026-04-15","ACTUAL",{"date":61,"type":59},"2016-12-29",{"date":63,"type":20},"2028-12-31",{"name":65,"class":66},"M.D. Anderson Cancer Center","OTHER",1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":74,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":88,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":5},"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":76,"type":20},145,"INTERVENTIONAL",[79],"PHASE2","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)",[82,83,84,85,27,32,26,31,25,30,86,87],"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",[82,83,87,86,30,25,31,26,32,27],"2025-07-28",{"date":91,"type":59},"2025-07-30",{"date":93,"type":59},"2021-07-02",{"date":95,"type":20},"2032-06-01",{"name":97,"class":66},"Jonathan Schoenfeld, MD, MPH"]