[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"larynx-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:larynx-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,49,84,117,142,175,207,239],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100570373","phase-3-lymphocyte-sparing-and-radio-immunotherapy-in-head-and-neck-carcinoma-100570373",false,"NCT06706401","Lymphocyte-Sparing And Radio-Immunotherapy in Head and Neck Carcinoma","A Multicenter, Randomised 2*2 Factorial Design Comparing Standard to Reduced-target Volume Radiotherapy With or Without All-trans Retinoic Acid (ATRA) in Patients With Lateralised Oropharyngeal, Laryngeal and Hypopharyngeal Squamous Cell Carcinoma.","LYSARI","Inclusion criteria :\n\nI1. Male or female patients aged ≥ 18 years old at time of inform consent signature.\n\nI2. Patients with primary head and neck tumour up to, but not crossing the midline, previously untreated with histologically-confirmed squamous cell carcinoma of:\n\n* the oropharynx p16-, larynx or hypopharynx : T1\u002FN2a-N2b, T2\u002FN0-N2b, T3\u002FN0-N2b (UICC 8th Ed.), or\n* the oropharynx p16+ : T1\u002FN1 (multiple nodes), T2-T3\u002FN0-N1 (UICC 8th Ed.).\n\nI3. Patients with lymph node staging assessed by an FDG-PET\u002FCT with no contralateral nodal uptake.\n\nI4. Patients amenable to treatment with RT or concomitant chemo-radiotherapy as decided by the treating physician as a function of tumor stage, tumor location, performance of the patients.\n\nI5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.\n\nI6. Adequate hematologic and end-organ function, defined by the following laboratory test results obtained within 7 days prior to randomisation :\n\nHematological (without transfusion within 2 weeks) :\n\n* Neutrophils count \\> 1.5 × 109 \u002FL\n* Platelets count \\> 75 × 109 \u002FL\n* WBC≥ 3.0 × 109 \u002FL\n\nHepatic function :\n\n* Total Bilirubin \\\u003C 1.5 × ULN (except for Gilbert's syndrome which will allow bilirubin ≤ 3 ULN).\n* Alanine aminotransferase (ALT) ≤ 2.5 × ULN.\n* Aspartate aminotransferase (AST) ≤ 2.5 × ULN.\n* Albumin \\>3.0g\u002FdL\n\nRenal function :\n\n* Serum creatinine \\\u003C 1.5 ×ULN.\n\nI7. QTcF ≤450ms for men and 470ms for women, from 3 electrocardiograms on screening ECG, within 7 days prior randomisation.\n\nI8. Women patients of child-bearing potential are eligible, provided they have a negative serum or urine pregnancy test within 7 days prior randomisation, and agrees to use adequate contraception for up to 1 month after the end of study treatments.\n\nI9. Fertile men must agree to use an effective method of contraception during the study and for up to 1 month after the end of study treatments.\n\nI10. Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed and should be able and willing to comply with study visits and procedures as per protocol.\n\nI11. Patients must be covered by a medical insurance in country where applicable.\n\nExclusion criteria :\n\nE1. Patient with primary tumor crossing the midline or patients with bilateral primary tumors.\n\nE2. Patients with T1-N0 (p16-), T1-N1 (p16-), T1-N0 (p16+), T4 (p16- and p16+), bilateral lymph nodes or nodal disease more than 6 cm (p16- and p16+).\n\nE3. Patients with unknown primary tumor size as per TNM i.e. T0-N1 to T0-N3, p16- or p16+.\n\nE4. Patients with contralateral FDG-PET\u002FCT nodal uptake.\n\nE5. Patient with any previous anti-cancer therapy for HNSCC (all prior treatment are forbidden: chemotherapy, radiotherapy, targeted therapy, immunotherapy or any other therapy approved or experimental).\n\nE6. Patient with malignancies other than HNSCC within 3 years prior to randomisation with the exception of adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localised prostate cancer treated surgically with curative intent.\n\nE7. Patient with ongoing or anticipation of need for systemic immunosuppressive medication (including, but not limited to, glucocorticoids, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-alpha agents); with the exceptions of intranasal, inhaled or topical corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid.\n\nE8. Patient with ongoing or anticipation of need for systemic immunostimulatory agents (including, but not limited to, interferons and IL-2).\n\nE9. Patient with concurrent treatment with any other anti-cancer treatment, approved or investigational agent or participation in another clinical trial with therapeutic intent.\n\nE10. Patient with infectious diseases :\n\n* Severe infection within 4 weeks prior to randomisation, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia,\n* Active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test at screening),\n* Active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA at screening,\n* HIV infection,\n* Active tuberculosis.\n\nE11.Patient with any psychological, cognitive, familial, sociological or geographical condition potentially hampering compliance with the study protocol, completion of patient reported measures and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n\nE12. Patient with known hypersensitivity to tretinoin, other retinoids, soya, peanut or to any of the excipients of vesanoid.\n\nE13. Patient with known malabsorption syndrome and\u002For unable to swallow oral medication.\n\nE14.Patient with ongoing or expected need for concomitant treatment with vitamin A, tetracyclines, other retinoids, anti-fibrinolytic agent, and strong inducers or inhibitors of CYP3A4.\n\nE15.Pregnant or lactating woman.","ALL","18 Years",{"count":20,"type":21},460,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The aim of this study is to investigate the effect of ATRA (Vesanoid) and the effect of tailored radiotherapy in patients with squamous cell carcinoma of the oropharynx, larynx or hypopharynx.",[27,28,29,30],"Oropharynx Cancer","Larynx Cancer","Hypopharynx Cancer","Primary Head and Neck Tumor",[32,33,34,35,36],"Localised squamous cell carcinoma of head and neck","Previously untreated","Standard radiotherapy","Tailored radiotherapy","Vesanoid","RECRUITING","2026-04-21",{"date":40,"type":41},"2026-04-24","ACTUAL",{"date":43,"type":41},"2025-02-20",{"date":45,"type":21},"2029-01",{"name":47,"class":48},"Centre Leon Berard","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":71,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100597801","phase-2-a-study-of-sacituzumab-govitecan-in-combination-with-cetuximab-in-people-with-head-and-neck-squamous-cell-cancer-hnscc-100597801","NCT07063212","A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC)","A Phase II Study of Sacituzumab Govitecan in Combination With Cetuximab in Patients With Recurrent Metastatic HNSCC That Has Progressed After First-Line Therapy","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck arising from the sinuses, nasal cavity, oral cavity, oropharynx, hypopharynx, and larynx. Other sites not listed will be subject to PI discretion.\n\n  * Advanced disease (Stage IV or M1 disease) not amenable to curative local therapy with surgery and\u002For radiation based approaches\n  * Progression on first line anti-PD(L)1 therapy with or without chemotherapy or as part of a combination in a clinical trial\n  * HPV status for oropharynx primary must be previously confirmed or can be performed on available archival or fresh biopsy via p16 immunohistochemistry or HPV specific testing via PCR or RNA ISH. Patients are able to enroll and initiate treatment so long as this is in progress. Exceptions may be made after discussion and review with P.I.\n  * Have measurable disease per RECIST v1.1 criteria. Tumor lesions situated in previously radiated area may be utilized if they are measurable and progression has been demonstrated in these lesions.\n* Male or female patients 18 years of age or older on the day of consent.\n* ECOG Performance Status of 0 to 1.\n* Adequate hematologic function within 30 days prior to registration, defined as follows:\n\n  * Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3\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\n* Adequate renal function within 30 days prior to registration, defined as follows:\n\n  o Serum creatinine \\\u003C 2.0 x upper limit of normal (ULN) or creatinine clearance (CCr)\n\n  ≥ 30 ml\u002Fmin determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = \\[(140 - age) x (wt in kg)\\] \\[(Serum Cr mg\u002Fdl) x (72)\\] CCr female = 0.85 x (CrCl male)\n* Adequate hepatic function within 30 days prior to registration, defined as follows:\n\n  * Total bilirubin ≤ 1.5 × ULN (except for unconjugated hyperbilirubinemia or Gilbert's syndrome). Direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 × ULN.\n  * AST and ALT \\\u003C 2.5 x the upper limit of normal\n  * Albumin ≥ 3 g\u002FdL\n* International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants.\n* Activated Partial Thromboplastin Time (aPTT) or Partial Thromboplastin Time (PTT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.\n* Female patients are eligible to participate if they are not pregnant, not breastfeeding and at least one of the following conditions applies:\n\n  * Not a woman of childbearing potential\n  * A woman of childbearing potential who agrees to use highly effective contraception from signing of the ICF through six months after the last study treatment administration.\n\nNotes:\n\ni. Female of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\>1 year. ii. Highly effective contraception methods include:\n\n* Total abstinence\n* Male or female sterilization\n* Combination of any 2 of the following categories (Categories 1+2, 1+3, or 2+3):\n\n  * Category 1: Use of oral, injected, or implanted hormonal methods of contraception.\n  * Category 2: Placement of an intrauterine device or intrauterine system.\n  * Category 3: Category 3: Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository.\n  * A female participant who is of childbearing potential must have a negative serum β-human chorionic gonadotrophin (β-hCG) pregnancy test within 72 hours prior to the first administration of study treatment or be surgically\u002Fbiologically sterile (hysterectomy or bilateral oophorectomy) or postmenopausal. Note: Postmenopausal females are defined as those who are:\n* Age \\> 50 years with amenorrhea for ≥ 12 months.\n* Age ≤ 50 years with six months of spontaneous amenorrhea and follicle stimulating hormone level within postmenopausal range (\\> 40 mIU\u002FmL).\n\n  * Male patients must agree to use contraception and refrain from sperm and egg donation from the time period between signing of the ICF and through five months after the last dose of study drug\n  * The subject must provide voluntary study-specific informed consent prior to study entry.\n\nExclusion Criteria:\n\n* Patients must not have received more than 2 prior line of systemic treatment (i.e. in the second or third line of treatment) in the recurrent\u002Fmetastatic setting.\n\n  o Ambiguity regarding lines of treatment a patient has received will be subject to PI review and approval.\n* Patients with previous severe infusion or allergic reactions to EGFR antibody based therapy that is deemed unsafe for re-challenge based on assessment by PI and\u002For consultation with allergy\u002Fimmunology.\n* Patients who have previously received topoisomerase I inhibitors for HNSCC\n* Patients who have a confirmed or suspected diagnosis (subject to P.I. discretion) of Gilbert's Syndrome\n* Have had a prior anti-cancer biologic agent, chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1.\n* Have not recovered (ie, ≤ Grade 1) from AEs due to a previously administered agent.\n\n  * Note: Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are exceptions to this criterion and may qualify for the study.\n  * Note: If subjects underwent major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study drug.\n  * Note: Subjects with Grade ≤ 2 immune-mediated toxicities (except colitis which must be recovered, \\\u003C Grade 1) related to immunotherapy and\u002For radiation treatment that are long lasting, but stable on treatment and not requiring agents that are excluded by this protocol may qualify for the study.\n* Patients with simultaneous primary cancers aside from HNSCC will be excluded unless otherwise approved by PI.\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate for the malignancy treated at 5 years is estimated to be 90% or greater, unless otherwise approved by PI\n* Severe, active co-morbidity defined as the following:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months\n  * Transmural myocardial infarction within the last 6 months\n  * Acute infection requiring intravenous therapy at the time of registration\n  * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration\n  * Hepatic Insufficiency resulting in clinical jaundice and\u002For coagulation defect\n* Have known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, no evidence of new or enlarging brain metastases and are taking ≤ 20 mg\u002Fday of prednisone or its equivalent. All subjects with carcinomatous meningitis are excluded regardless of clinical stability.\n* Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease), immune-mediated colitis, or gastrointestinal (GI) perforation within 6 months of C1D1.\n* Known acquired immunodeficiency syndrome due to untreated\u002Fpoorly controlled human immunodeficiency virus. Other diagnosed immunodeficiency syndromes or disorders will require the review and approval of the site PI.\n* Positive test for hepatitis B surface antigen (HBsAG) or hepatitis C virus antibody (anti-HCV), indicating acute or chronic infection. Patients who test positive for anti-HCV but negative for HCV ribonucleic acid (RNA) are permitted to enroll.\n* Herbal remedies known to potentially interfere with major organ function within 28 days prior to the first dose of study treatment, unless agreed otherwise between the PI and treating investigator.\n* Female patients who are pregnant, breastfeeding, or plan on becoming pregnant during the study.",{"count":57,"type":21},40,[59],"PHASE2","The purpose of this study to find out whether sacituzumab govitecan in combination with cetuximab is an effective and safe treatment approach for people with recurrent and\u002For metastatic head and neck squamous cell cancer (HNSCC).",[62,63,64,65,27,29,28,66,67,68,69,70],"Squamous Cell Carcinoma of Head and Neck","Sinus Cancer","Nasal Cavity Cancer","Oral Cavity Cancer","Oral Squamous Cell Carcinoma","Oropharynx Squamous Cell Carcinoma","Hypopharynx Squamous Cell Carcinoma","Larynx Squamous Cell Carcinoma","HPV Positive Oropharyngeal Squamous Cell Carcinoma",[62,63,64,65,27,29,28,66,67,68,69,70,72,73,74],"Sacituzumab Govitecan","25-094","Memorial Sloan Kettering Cancer Center","2026-02-17",{"date":77,"type":41},"2026-02-19",{"date":79,"type":41},"2025-07-02",{"date":81,"type":21},"2028-01-02",{"name":74,"class":48},7,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":96,"conditions":97,"keywords":103,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"100390804","confirm-magnetic-resonance-guided-radiation-therapy-100390804","NCT04368702","CONFIRM: Magnetic Resonance Guided Radiation Therapy","Clinical Onboard Utilization of Image Guided Radiation Therapy With Magnetic Resonance (CONFIRM): A Master Protocol","CONFIRM","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed malignancy requiring radiation\n* Age 18 years of older\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)\n* Ability to understand and the willingness to sign a written informed consent document.\n* Any further criteria listed in the specific disease site cohort\n\nExclusion Criteria\n\n* History of allergic reactions attributed to gadolinium-based IV contrast\n\n  \\-- Note: If patient will not receive contrast, this is not applicable and kidney function will not affect eligibility\n* Severe claustrophobia or anxiety\n* Participants who cannot undergo an MRI\n* Any other exclusion criteria listed in the specific disease site cohort",{"count":93,"type":21},70,[95],"NA","This research is being done to determine the safety and feasibility of using a type of radiation guided by magnetic resonance imaging (MRI) and chemotherapy to treat patients with gastric and breast cancer. The name of the radiation machine involved in this study is the MRIdian Linear Accelerator.",[98,99,100,101,28,102],"Gastric Cancer","Invasive Breast Cancer","in Situ Breast Cancer","Mantle Cell Lymphoma","Bladder Cancer",[98,99,100,104,105,106],"Lymphoma","Larynx","Bladder","2026-02-05",{"date":109,"type":41},"2026-02-09",{"date":111,"type":41},"2021-05-01",{"date":113,"type":21},"2029-06-18",{"name":115,"class":48},"Brigham and Women's Hospital",2,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":141},"100500199","multi-site-trial-of-navigation-vs-treatment-as-usual-to-improve-initiation-of-timely-adjuvant-therapy-100500199","NCT05793151","Multi-Site Trial of Navigation vs Treatment as Usual to Improve Initiation of Timely Adjuvant Therapy","A Stepped Wedge Cluster Randomized Trial Comparing a Navigation-Based Multilevel Intervention With Treatment as Usual to Improve Initiation of Timely Postoperative Radiation Therapy in Adults With Head and Neck Cancer","ENDURE","Inclusion Criteria:\n\n1. Age \\>\u002F= 18 years\n2. Squamous cell carcinoma (SCC) (or histologic variant) of the oral cavity, oropharynx, hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity\n3. American Joint Committee on Cancer (AJCC) 8th edition clinical T3-4 or \\>N1 SCC of the oral cavity, oropharynx, hypopharynx, larynx, paranasal sinuses, nasal cavity, or unknown primary.\n4. No history of radiation therapy for treatment of HNSCC in the definitive or adjuvant settings that would, at the discretion of the enrolling clinician, affect the patient's need for adjuvant RT.\n5. Plan for curative intent surgery at one of the participating centers\n6. Plan for PORT (regardless of whether it is at the surgical center) with or without concurrent chemotherapy following curative intent surgery based on the expectation of at least one of the following adverse features on final pathologic evaluation: pT3 or pT4 primary, N1 or greater nodal disease, perineural invasion (PNI), or lymphovascular invasion (LVI).\n\nExclusion Criteria:\n\n1. Inability to speak or read English or Spanish.\n2. Severe mental illness that would prevent trial participation.\n3. HPV-positive OPC or unknown primary SCC staged as cT1-2N1 with a single ipsilateral LN \\\u003C 3 cm\n4. Synchronous untreated malignancy expected to impact life expectancy",{"count":126,"type":21},532,[95],"The goal of this clinical trial is to compare the effectiveness of a navigation-based multilevel intervention (ENDURE) with treatment as usual (TAU) to improve the initiation of guideline-adherent postoperative radiation therapy among patients with head and neck cancer. The main questions the trial aims to answer are:\n\n1. Does ENDURE improve initiation of timely PORT relative to treatment as usual?\n2. What are the mechanisms through which ENDURE improves timeliness to treatment?\n3. What are the barriers and facilitators to the implementation of ENDURE into routine clinical care?",[130,131,27,65,28],"Head and Neck Cancer","Head and Neck Squamous Cell Carcinoma","2025-12-04",{"date":134,"type":41},"2025-12-11",{"date":136,"type":41},"2023-10-30",{"date":138,"type":21},"2028-03-30",{"name":140,"class":48},"Medical University of South Carolina",4,{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":158,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":4},"100612544","phase-2-capecitabine-prior-to-tumor-resection-in-ent-oncology-capture-100612544","NCT07254962","CApecitabine Prior to TUmor Resection in Ent Oncology (CAPTURE)","CAPTURE","Inclusion Criteria:\n\n* • Previously untreated, histologically confirmed non-HPV related HNSCC and radiologically or histologically confirmed stage I or IVA (AJCC 8th edition).\n\n  * No evidence of distant metastatic disease.\n  * Able to undergo protocol therapy, including necessary imaging and surgery.\n  * If female: may participate if not actively pregnancy nor breastfeeding.\n  * If male: must agree to refrain from donating sperm and must either be abstinent or agree to use contraception.\n  * Performance status (ECOG) of 0, 1 or 2.\n\nExclusion Criteria:\n\n* History of immunodeficiency, HBV, HCV, HIV. No HBV, HCV or HIV testing is required unless mandated by local health authority.\n* Active infection requiring systemic therapy.\n* Previous allogenic tissue\u002Fsolid organ transplant.\n* Known severe hypersensitivity (≥ Grade 3) to capecitabine, its active substance and\u002For any of its excipients.\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Known DYPD mutation.\n* Known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial.\n* Received prior systemic anticancer therapy including investigational agents for the current malignancy prior to allocation.\n* Currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment.\n* Known additional malignancy that is progressing or requires active treatment within the past (5 years), excluding basal cell carcinoma or cutaneous squamous cell carcinoma.",{"count":150,"type":21},75,[59],"head and neck squamous cell carcinoma (HNSCC) is a type of cancer that affects areas such as the mouth, throat, and voice box. Despite medical progress, little has changed in the care for patients with HPV-negative cancer. The standard care involves surgery followed by radiation or chemotherapy if needed. However, delays in starting treatment - especially beyond six weeks - are linked to worse outcomes. Many patients also experience cancer returning within two years, often making it harder to treat. This study aims to improve outcomes by giving patients a short course of capecitabine, a chemotherapy pill, before surgery. Capecitabine is easier to tolerate than traditional intravenous chemotherapy and has shown promising results in shrinking tumors. Researchers believe that starting this oral treatment early could reduce delays, shrink tumors, make surgery less complex, and improve survival. The clinical trial will randomly assign patients with newly diagnosed stage III or IVa HPV-negative head and neck cancer to receive either standard care or capecitabine before surgery. Surgery will be performed within six weeks of diagnosis, followed by additional therapy as needed. The study will measure how well the tumor responds under the microscope after surgery, how much it shrinks on scans, the safety of the treatment, and cancer-free survival at two years. It will also explore biological markers linked to treatment response.\n\nIf successful, this approach could offer a simpler, faster, and more effective way to treat head and neck cancer, leading to earlier treatment, less invasive surgery, and improved patient outcomes. The study plans to include about 62 patients to evaluate the benefits of this new treatment strategy",[154,155,156,28,157],"Head Neck Cancer","Mouth Cancer","Throat Cancer","Skin Cancer Face",[159,160,161,162,163,164],"window of opportunity","surgery","neoadjuvant","capecitabine","Head and neck cancer","HPV-negative","NOT_YET_RECRUITING","2025-11-19",{"date":168,"type":41},"2025-11-28",{"date":170,"type":21},"2026-01-01",{"date":172,"type":21},"2031-01-01",{"name":174,"class":48},"Sir Mortimer B. Davis - Jewish General Hospital",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":186,"conditions":187,"keywords":189,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":141},"100366895","voices-voice-quality-after-transoral-co2-laser-surgery-versus-single-vocal-cord-irradiation-for-larynx-cancer-100366895","NCT04057209","VoiceS: Voice Quality After Transoral CO2-Laser Surgery Versus Single Vocal Cord Irradiation for Larynx Cancer","VoiceS: Voice Quality After Transoral CO2-Laser Surgery Versus Single Vocal Cord Irradiation for Unilateral Stage 0 & I Glottic Larynx Cancer - A Randomized Phase III Trial","VoiceS","Inclusion Criteria\n\n1. ECOG performance status 0-1 at the time of registration\n2. ≥18 years of age\n3. Baseline assessments and documentation of voice quality by means of VHI, JS, RBH, GNE, SPR\n4. Histopathologically confirmed, previously untreated unilateral (cT1a or unilateral cTis) stage 0 or I glottic larynx cancer based on the UICC staging system (8th edition)\n5. History and physical examination by treating physician (head and neck surgeon and radiation oncologist) within 28 days prior registration\n6. The patient must be expected to withstand both study interventions\n7. The patient must have undergone panendoscopy with assessment for the feasibility of transoral exposure for resection. Patients without feasible exposure are not eligible\n8. Localization of the tumor should allow resection with a minimum of 2 mm macroscopical margin without extension to the contralateral vocal fold, without partial resection of the arytenoid cartilage and without resection of parts of thyroid cartilage (Cordectomy Type I-IV according the classification of the European Laryngological Society)13\n9. Hemoglobin ≥10 g\u002FdL or 6.2 mmol\u002FL (Note: The use of transfusion to achieve Hgb ≥10 g\u002FdL is acceptable) within the 28 days prior to accrual\n10. Women with child-bearing potential and using effective contraception, and not pregnant and agree not to become pregnant (see section 8.6) during participation in the trial and 30 days after radiotherapy. A negative pregnancy test before inclusion (within 28 days) into the trial is required for all women with child-bearing potential. Men agree not to father a child during participation in the trial and 30 days after radiotherapy.\n11. Written informed consent, signed by the patient and the investigator.\n\nExclusion Criteria\n\n1. Infection hampering the voice quality at the time of voice assessment\n2. Involvement of the anterior commissure by the tumor\n3. Previous oncologic surgery with curative intent (exception: excisional biopsies resulting in unacceptable close R0 or R1\u002FR2 margins may be included) or radiotherapy to larynx\n4. Synchronous or previous malignancies. Exceptions are adequately treated basal cell carcinoma or SCC of the skin, or in situ carcinoma of the cervix uteri, low-risk prostate cancer or breast with a cancer-free follow-up time of at least 3 years, or other previous malignancy with a progression-free interval of at least 5 years\n5. Co-existing disease prejudicing survival (expected survival less than 6 months)\n6. Active bacterial or fungal infection requiring intravenous antibiotics at the time of registration\n7. History of any voice disorders (not related to the SCCGL) lasting longer than 3 weeks\n8. Illness requiring hospitalization or precluding study therapy within 28 days before registration\n9. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial",{"count":184,"type":21},34,[95],"Laser surgery and radiotherapy are well-established standards of care for unilateral stage 0 \\& I carcinoma in situ (Cais) and squamous cell carcinoma of glottic larynx (SCCGL). Based on meta-analyses, functional and oncological outcome after both treatment modalities are comparable1-5. However, no properly conducted randomized trials comparing these treatments exist. The only such trial with the endpoint of voice quality had to be prematurely closed due to low accrual6.\n\nThe traditional radiotherapy involves the treatment of the whole larynx. Recently, a new radiotherapy technique was introduced by a team of researchers from Netherlands, where the treated target volume consists of involved vocal cord and therefore 8 to 10-fold smaller than the target volumes used for traditional whole larynx irradiation. The treatment is reduced to 16 fractions which corresponds to 3 weeks and a day7-12. The results of a prospective cohort (n=30) with single vocal cord irradiation (SVCI) were compared with the results of a historical prospective cohort previously treated with whole larynx radiotherapy (n=131) in the same institute. The median follow-up was 30 months. The voice handicap index (VHI) at all time points beginning from the 6th week after SVCI was significantly superior to the same time points with conventional radiotherapy. Moreover, a comparable local control with SVCI (100%) vs. conventional radiotherapy (92%) was reported at two years, p=0.2412.\n\nBased on this information, the investigators' main aim is to compare SVCI to Transoral CO2-Laser Microsurgical Cordectomy (TLM) with the main focus of patient-reported voice quality.",[188,28],"Glottis Tumor",[190,191,192,193,160,194,195,196,197],"head and neck cancer","squamous cell carcinoma","carcinoma in situ","radiotherapy","transoral laser microsurgery","patient reported outcome","quality of life","voice","2025-10-01",{"date":200,"type":41},"2025-10-07",{"date":202,"type":41},"2019-11-20",{"date":204,"type":21},"2030-11-30",{"name":206,"class":48},"Olgun Elicin",{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":17,"minAge":214,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":217,"phases":4,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":238},"100465202","special-care-patterns-for-elderly-hnscc-patients-undergoing-radiotherapy-100465202","NCT05337631","Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy","SENIOR","Inclusion Criteria:\n\n* definitive (chemo-)radiotherapy of locoregionally advanced (cT3-4 and\u002For cN+) head-and-neck squamous cell carcinomas (HNSCC) of the oral cavity, oropharynx, hypopharynx or larynx\n* primary treatment since 2005\n* age ≥65 years at the time of (chemo-)radiotherapy\n\nExclusion Criteria:\n\n* adjuvant (chemo-)radiotherapy\n* history of previous head-and-neck cancers or radiotherapy in the head-and-neck region\n* distant metastases at (chemo-)radiotherapy initiation (cM1)\n* HNSCCs of the nasopharynx, salivary glands, skin or with unknown primary","65 Years",{"count":216,"type":21},1500,"OBSERVATIONAL","The number of elderly head-and-neck squamous cell carcinoma (HNSCC) patients is increasing; however, the evidence regarding the ideal treatment for this often vulnerable and frail patient cohort is limited. Although the benefit of concomitant chemotherapy has been reported to decrease in elderly HNSCC patients based on the MACH-NC meta-analysis, it remains unknown whether state-of-the art radiotherapy techniques such as intensity-modulated radiotherapy (IMRT), modern supportive treatments and alternative chemotherapy fractionation (e.g., cisplatin weekly) may have altered this observation. The objective of this retrospective multinational multicenter study is to determine the oncological outcomes of elderly patients (≥65 years) with locally advanced HNSCCs undergoing definitive (chemo-)radiation and to investigate the influence of concomitant chemotherapy on overall survival and progression-free survival after adjusting for potential confounder variables such as age, performance status and comorbidity burden.",[220,65,27,29,28],"HNSCC",[222,223,224,225,226,227,228],"Elderly","Radiotherapy","Chemotherapy","Chemoradiotherapy","Cisplatin","Cetuximab","Real-world data","2025-03-24",{"date":231,"type":41},"2025-03-25",{"date":233,"type":41},"2021-06-01",{"date":235,"type":21},"2026-12-31",{"name":237,"class":48},"University Hospital Freiburg",18,{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":246,"enrollmentInfo":247,"targetDuration":4,"studyType":22,"phases":249,"briefSummary":250,"conditions":251,"keywords":253,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":269},"100519137","phase-2-neoadjuvant-chemoimmunotherapy-followed-by-radiation-or-organ-preservation-surgery-in-laryngealhypopharyngeal-cancer-100519137","NCT06039631","Neoadjuvant Chemoimmunotherapy Followed By Radiation Or Organ Preservation Surgery In Laryngeal\u002FHypopharyngeal Cancer","Neoadjuvant Immunotherapy And Chemotherapy Followed By Concurrent Chemoradiation Or Organ Preservation Surgery In Locally Advanced Laryngeal Cancer And Hypopharyngeal Cancer","Inclusion Criteria:\n\n1. Signing of the informed consent form and willingness to comply with the study protocol.\n2. Age ≥18 and ≤75 years.\n3. Histologically confirmed laryngeal or hypopharyngeal squamous cell carcinoma.\n4. Locally advanced laryngeal\u002Fhypopharyngeal cancer patients eligible for surgical resection (AJCC 8th edition stage: T2N+M0, T3-T4aN0-3M0).\n5. Presence of at least one measurable lesion before treatment, in accordance with RECIST 1.1 criteria for \"measurable lesions.\"\n6. Patients who have received neoadjuvant immunotherapy combined with chemotherapy and have achieved a partial response (PR) in the primary lesion according to RECIST 1.1 criteria and are suitable candidates for organ preservation surgery.\n7. Expected survival of more than 3 months.\n8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n9. Good organ function, meeting the following criteria:\n\n   1. Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL.\n   2. Platelet count ≥100×10\\^9\u002FL.\n   3. Hemoglobin ≥9 g\u002FdL.\n   4. Serum albumin ≥2.8 g\u002FdL.\n   5. Total bilirubin ≤1.5× upper limit of normal (ULN), ALT, AST, and\u002For ALP ≤3× ULN.\n   6. Serum creatinine ≤1.5× ULN and creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault formula, see Appendix III).\n   7. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5× ULN (patients on stable doses of anticoagulation with agents like low molecular weight heparin or warfarin, and INR within the expected therapeutic range, may be included).\n10. Patients with hepatitis B virus (HBV) infection, inactive\u002Fasymptomatic HBV carriers, or patients with chronic or active HBV infection with HBV DNA \\\u003C500 IU\u002FmL (or 2500 copies\u002FmL) at screening will be allowed to participate. Patients positive for hepatitis C antibodies, if HCV-RNA is negative at screening, will be allowed to participate.\n11. Females of childbearing potential must have a negative pregnancy test result in urine or serum ≤7 days before treatment initiation. They must use a medically accepted contraceptive measure (such as intrauterine device, oral contraceptives, or condoms) during the study treatment period, for at least 3 months after the last dose of toripalimab, and for at least 6 months after the last dose of chemotherapy.\n12. Non-sterilized male participants must be willing to use a medically accepted contraceptive measure (such as intrauterine device, oral contraceptives, or condoms) during the study treatment period, for at least 3 months after the last dose of toripalimab, and for at least 6 months after the last dose of chemotherapy.\n\nExclusion Criteria:\n\n1. History of allergic reactions to any components of toripalimab, paclitaxel, or cisplatin.\n2. Pre-existing tracheostomy due to laryngeal dysfunction before treatment.\n3. History of or concurrent presence of other malignancies (except for those cured and with no cancer-related survival exceeding 5 years, such as basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid cancer). Patients with concurrent hypopharyngeal and esophageal cancers, where the lesions are not anatomically adjacent, will be diagnosed as having dual primary tumors and will not be eligible for inclusion.\n4. Uncontrolled clinical cardiac symptoms or diseases, including:\n\n   1. NYHA Class II or higher heart failure.\n   2. Unstable angina.\n   3. Myocardial infarction within the past year.\n   4. Clinically significant ventricular or supraventricular arrhythmias requiring clinical intervention.\n5. Previous treatment with any of the following:\n\n   1. Use of any investigational drug within 4 weeks prior to the first dose of study treatment.\n   2. Concurrent participation in another clinical trial, unless it is an observational (non-interventional) clinical trial.\n   3. Requiring systemic treatment with corticosteroids (daily dose \\>10 mg prednisone equivalent) or other immunosuppressive medications within 2 weeks prior to the first dose of study treatment, excluding corticosteroids for localized inflammation or prophylaxis against allergies or nausea\u002Fvomiting. Other specific circumstances should be discussed with the investigator. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement therapy with a dose of \\>10 mg\u002Fday prednisone or equivalent are allowed.\n   4. Vaccination with anti-tumor vaccines or administration of live vaccines within 4 weeks prior to the first dose of study treatment (for patients who received COVID-19 vaccine, a 2-week interval is required).\n   5. Major surgery within 4 weeks before the first dose of study treatment or presence of severe trauma.\n6. Failure to recover to ≤ Grade 1 toxicity per CTCAE (except for alopecia and residual neuropathy related to prior platinum therapy) from previous cancer therapy or from any other cause unrelated to study\u002Fenrollment criteria.\n7. Experience of severe infections (CTCAE \\> Grade 2) within 4 weeks before the first dose of study treatment, such as severe pneumonia requiring hospitalization, sepsis, or complicated infections. Baseline chest imaging indicating active pulmonary inflammation, presence of symptoms and signs of infection within 4 weeks before the first dose of study treatment, or requirement for oral or intravenous antibiotics to treat infection are exclusion criteria.\n8. Active autoimmune disease or history of autoimmune disease, such as interstitial lung disease, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes. However, stable dose of thyroid replacement therapy for autoimmune-mediated hypothyroidism is allowed. Stable dose of insulin for type I diabetes is allowed. Patients with vitiligo or childhood-onset asthma\u002Fallergies requiring no intervention as adults are allowed.\n9. History of immune deficiency, including HIV positive test results, other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation.\n10. History of interstitial lung disease (excluding radiation pneumonitis not treated with steroids), non-infectious pneumonitis.\n11. Active tuberculosis infection found through medical history or CT scan, or presence of active tuberculosis infection within the past year prior to enrollment, or history of active tuberculosis infection more than 1 year ago but not formally treated.\n12. Presence of active hepatitis B (HBV DNA ≥500 IU\u002FmL or 2500 copies\u002FmL) or hepatitis C (HCV-RNA positive with HCV-RNA levels above the lower limit of detection of the assay) infection＊.\n13. Known history of substance abuse, alcohol abuse, or drug addiction.\n14. Pregnant or breastfeeding women.\n15. Other factors, as judged by the investigator, that may interfere with the participant's ability to comply with the study requirements or that may jeopardize the safety of the participant or the quality of the study data, including the presence of other severe diseases (including mental illness) requiring concurrent treatment, severe abnormal laboratory values, family or social factors, which might affect participant safety or data collection.\n\n    * For participants who are HBsAg-positive and either HBV DNA-negative or with HBV DNA \\\u003C500 IU\u002FmL or 2500 copies\u002FmL, after receiving stable antiviral treatment, they may be included in this trial (treatment should be ongoing for \\>2 weeks before enrollment, and continued for 6 months after the last dose of study treatment).","75 Years",{"count":248,"type":21},82,[59],"In the global landscape of cancer, head and neck malignancies are highly prevalent, with 878,000 new cases and 444,000 deaths recorded in 2020. Notably, laryngeal and hypopharyngeal cancers contribute to around 30% of these instances. More than 50% of patients are diagnosed with locally advanced disease, necessitating intensive treatments that significantly impact their quality of life. Despite these efforts, the prognosis for laryngeal and hypopharyngeal cancers remains grim, with a 5-year survival rate of 30% to 50%.\n\nPast approaches focused on preserving laryngeal function and patient well-being, including minimally invasive surgery, advanced radiotherapy, and induction chemotherapy. Our prior research highlighted the effectiveness of combining toripalimab-based induction therapy and chemotherapy, followed by concurrent chemoradiotherapy or surgery. Positive short-term outcomes and manageable side effects were observed, with encouraging larynx preservation rates after one year.\n\nAgainst this backdrop, the current study aims to explore neoadjuvant immunotherapy combined with chemotherapy for patients with locally advanced laryngeal and hypopharyngeal cancer. It seeks to compare the therapeutic efficacy and quality of life impacts of concurrent radiochemotherapy and organ-preserving surgery. The ultimate goal is to identify optimal strategies for future interventions.",[28,252],"Hypopharyngeal Cancer",[254,255,256,257,258,259],"organ preservation","PD-1 inhibitor","Immunotherapy","Neoadjuvant chemotherapy","Induction chemotherapy","larynx presrvation surgery","2023-09-09",{"date":262,"type":41},"2023-09-15",{"date":264,"type":41},"2023-08-22",{"date":266,"type":21},"2029-09-01",{"name":268,"class":48},"Fudan University",1]