[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-head-and-neck-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-head-and-neck-carcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,58,77,105],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100053899","cdna-and-residual-disease-after-chemoradiotherapy-for-locally-advanced-head-and-neck-squamous-cell-carcinomas-100053899",false,"NCT07178847","cDNA and Residual Disease After Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinomas","Evaluation of Circulating DNA as a Biomarker of Residual Disease After Chemoradiotherapy for Locally Advanced Head and Necksquamous Cell Carcinoma","NeckTAR-IN","Selection Criteria:\n\n* Patient included in NeckTAR study\n* Written informed consent signed for NeckTAR-IN study\n* Affiliation to the French social security system","ALL","18 Years","80 Years",{"count":21,"type":22},59,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this ancillary clinical trial is to evaluated circulating DNA as a biomarker of residual disease after chemoradiotherapy for locally advanced head and neck squamous cell carninoma.\n\nThe main question it aims to answer is :\n\n\\- Does circulating DNA (cDNA) be able to detect residual disease 3 months after the end of chemoradiotherapy ? Researchers will compare detection of cDNA at 3-months and objective response (clinical and radiological).\n\nParticipants will :\n\n* be included in the main study (Neck-TAR)\n* have a blood sample 1 and 3-month after the end of treatment",[28],"Locally Advanced Head and Neck Carcinoma",[30,31],"circulating DNA","residual disease","RECRUITING","2026-07-10",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":36},"2025-10-13",{"date":40,"type":22},"2031-07",{"name":42,"class":43},"Centre Jean Perrin","OTHER",4,{"id":46,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":47,"targetDuration":4,"studyType":23,"phases":48,"briefSummary":26,"conditions":49,"keywords":50,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":54,"completionDateStruct":55,"leadSponsor":56,"locationsCount":57},"100606691",{"count":21,"type":22},[25],[28],[30,31],"2026-06-01",{"date":53,"type":36},"2026-06-03",{"date":38,"type":36},{"date":40,"type":22},{"name":42,"class":43},3,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":65,"targetDuration":4,"studyType":23,"phases":67,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":76,"locationsCount":44},"100493862","prediction-of-residual-disease-by-circulating-dna-detection-after-potentiated-radiotherapy-for-locally-advanced-head-and-neck-cancer-100493862","NCT05710679","Prediction of Residual Disease by Circulating DNA Detection After Potentiated Radiotherapy for Locally Advanced Head and Neck Cancer","NeckTAR","Inclusion Criteria:\n\n* Age ≥ 18 years and ≤ 80 years\n* Histologically confirmed, never treated squamous cell carcinoma with lymph node involvement\n* squamous cell carcinoma p16+or p16-, stage III (N1), IVa or IVb (UICC classification 8th edition), N1 minimum, and oropharyngeal sqamous cell carcinomas p16+ stage I or II, N1 minimum, resectable but not operated or unresectable, with indication for concomitant or sequential radiochemotherapy with induction chemotherapy using Docetaxel, Platinum, 5-Fluorouracil (TPF or modified TPF according to the practices of the investigating centers)\n* Oral cavity, oropharynx, hypopharynx or larynx, cervical adenopathies without primary\n* Availability of FFPE samples prior to treatment initiation\n* Detection of circulating DNA in the initial blood sample\n* Obtaining informed consent from the patient\n* Affiliation to the French social security system\n\nExclusion Criteria:\n\n* Tumor of the nasopharynx, sinuses, nasal cavity, salivary glands or thyroid cancer\n* Treatment by exclusive radiotherapy\n* Contraindication to cervical lymph node dissection\n* Metastatic disease (stage IVc)\n* Previous treatment for head and neck cancer\n* History of other cancer in the last 3 years (except carcinoma in situ, basal cell skin carcinoma, localized prostate cancer Gleason 6)\n* Pregnant or breastfeeding woman\n* Patient under guardianship or curators\n* Psychological disorder (cognitive disorders, vigilance disorders, etc.) or social reasons (deprivation of liberty by judicial or administrative decision) or geographical reasons that could compromise the medical follow-up of the trial or compliance with the treatment",{"count":66,"type":22},63,[25],"Sixty percent of newly diagnosed head and neck squamous cell carcinomas (HNSCCs) are at a locally advanced (LA) stage. Depending on tumor site, stage, and resectability, locoregional failure rates can range from 35% to 65%. The persistence of residual disease at the end of treatment is a major prognostic element but is not always reliably assessed by current imaging techniques. Up to 40-50% of patients have residual adenomegaly and only 30% have viable disease when further adenectomy is performed. Sensitive and reproducible detection of residual disease after treatment is a major challenge in this patient category.\n\n18F-fluorodeoxyglucose (18F-FDG) positron emission tomography-computed tomography (PET\u002FCT) guided surveillance, with a negative predictive value of 95-97%, has proven to be non-inferior to cervical curage in HNSCCs with residual adenomegaly. Cervical curage is now indicated only if the response assessed by PET-CT is incomplete. Nevertheless, the ability of PET-CT to predict treatment failure is unsatisfactory due to a high frequency of false positives, because of inflammatory changes, with a positive predictive value of about 20-50%.\n\nCirculating tumor DNA (ctDNA) may provide a more reliable assessment of response to potentiated radiotherapy. Liquid biopsy monitoring of response in patients treated with potentiated radiation therapy for locally advanced HNSCCs a has been shown to be feasible. In 85% of patients, ctDNA is detectable and correlates significantly with tumor volume and response to treatment. In addition, one study showed that post-radiotherapy analysis of circulating HPV16 viral DNA (cvDNA) in patients with HPV16-related HNSCCs complemented PET-CT and helped guide management decisions. HPV16 cvDNA and PET-CT have similar negative predictive values, whereas the positive predictive value is higher for HPV16 cvDNA (100% versus 50%). Nevertheless, current data are insufficient to allow routine use of this marker.\n\nThis is a multicenter, single arm, open study for patients with a locally advanced head and neck cancer for which a potentiated radiotherapy is indicated.",[28],"2026-05-21",{"date":72,"type":36},"2026-05-26",{"date":74,"type":36},"2024-01-17",{"date":40,"type":22},{"name":42,"class":43},{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100535975","phase-3-neoadjuvant-immunochemotherapy-for-laoscc-100535975","NCT06258811","Neoadjuvant Immunochemotherapy for LAOSCC","Neoadjuvant Immunochemotherapy With Tislelizumab, Albumin Paclitaxel and Cisplatin Followed by Standard Therapy Versus Standard Therapy for Locally Advanced Oral Squamous Cell Carcinoma, a Multicenter Randomized Phase 3 Trial","Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1\n2. Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region)\n3. Primary tumor with a clinical stage of III\u002FIVA (T1-2\u002FN1-2\u002FM0 or T3-4a\u002FcN0-2\u002FM0, AJCC 2018)\n4. Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)\n5. Blood routine: white blood cells (WBCs) \\>3,000\u002Fmm3, hemoglobin \\>8 g\u002FL, platelets \\>80,000\u002Fmm3\n6. Liver function: alanine amino transferase\u002Faspartate amino transferase (ALAT\u002FASAT) \\\u003C2.5 times the upper limit of normal and bilirubin \\\u003C1.5 times the upper limit of normal\n7. Renal function: Serum creatinine \\\u003C1.5 times the upper limit of normal\n8. Coagulation function: INR、PT、APTT\\\u003C1.5 times the upper limit of normal\n9. Signed the informed consent form\n\nExclusion Criteria:\n\n1. Unresolved grade 2 \\[(Common Terminology Criteria for Adverse Events (CTCAE 5.0)\\] or higher toxic reactions caused by previous anticancer treatments\n2. Known allergic reaction (grade 3-4) to any ingredients or excipients of the therapy\n3. Known history of malignancy, unless been cured and no recurrence for 5 years\n4. Known history of radiation to head and neck\n5. Active severe clinical infection (\\> National Cancer Institute (NCI)-CTCAE version 5.0 grade 2 infection)\n6. Obvious cardiovascular abnormalities \\[such as myocardial infarction, superior vena cava syndrome, grade 2 or higher heart disease diagnosed according to the New York Heart Association (NYHA) classification 3 months before enrollment\\]\n7. Patients receiving immunology-based treatment for any reason\n8. Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy\n9. Pregnant or lactating women\n10. Known active hepatitis B or C. Active hepatitis B is defined as a known HBsA positive with HBV DNA≥500 IU\u002FmL. Active hepatitis C is defined as a known hepatitis C antibody positive and a known amount of hepatitis C virus HCV RNA results greater than the lower limit of detection. The presence of other serious liver diseases, including chronic autoimmune liver disease, primary biliary cirrhosis or sclerosing cholangitis, alcoholic liver disease, or non-alcoholic steatohepatitis (NASH)\n11. Complicated with severe, uncontrolled infection or known human immunodeficiency virus (HIV) infection, or diagnosed as acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or history of allogeneic tissue\u002Forgan transplantation, stem cell or bone marrow transplantation, or solid organ transplantation\n12. Participation in other clinical trials within 30 days before enrollment\n13. Other situations that the investigator considers unsuitable with respect to participating in the trial","75 Years",{"count":86,"type":22},134,[88],"PHASE3","To evaluate the prognostic efficacy of neoadjuvant immunochemotherapy with tislelizumab, albumin paclitaxel and cisplatin followed by radical surgery and adjuvant therapy compared with standard therapy for patients with locally advanced and resectable oral squamous cell carcinoma.",[91,28],"Oral Squamous Cell Carcinoma",[93,94],"Oral squamous cell carcinoma","Neoadjuvant immunochemotherapy","2025-03-10",{"date":97,"type":36},"2025-03-13",{"date":99,"type":36},"2024-02-20",{"date":101,"type":22},"2028-12-30",{"name":103,"class":43},"Lai-ping Zhong",1,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":112,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":104},"100451250","phase-1-gabapentin--ketamine-for-preventiontreatment-of-acutechronic-pain-in-locally-advanced-head-and-neck-cancer-100451250","NCT05156060","Gabapentin & Ketamine for Prevention\u002FTreatment of Acute\u002FChronic Pain in Locally Advanced Head and Neck Cancer","Phase I\u002FII Trial of Gabapentin Plus Ketamine for Prevention and Treatment of Acute and Chronic Pain in Locally Advanced Head and Neck Cancer Patients Undergoing Primary or Adjuvant Chemoradiation","Inclusion Criteria:\n\n* Histologically proven cancer of the head and neck cancer\n* Locally advanced non-metastatic disease (T3N0M0, T4N0M0, T1-4N1-3M0)\n* Planned primary or adjuvant radiation or chemoradiation therapy\n* Willing and able to provide informed consent\n* ECOG PS 0-2\n* Age ≥ 21 years\n* English speaking\n\nExclusion Criteria:\n\n* Currently on gabapentin or ketamine\n* Prior non-tolerance of gabapentin or ketamine\n* Unable to administer ketamine intranasally due to anatomical restrictions\n* History of seizure disorder\n* History of schizophrenia\n* History of increased intracranial pressure\n* Glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m2","21 Years",{"count":114,"type":22},64,[116,117],"PHASE1","PHASE2","This is a study to establish a safe and feasible dose for prophylactic use of a combination of gabapentin and ketamine in head and neck cancer patients undergoing chemoradiation.",[120,28],"Head and Neck Cancer","2024-10-17",{"date":123,"type":36},"2024-10-21",{"date":125,"type":36},"2022-01-24",{"date":127,"type":22},"2026-12-31",{"name":129,"class":43},"Natalie Lockney"]