[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"larynx-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:larynx-squamous-cell-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100588919","immune-biomarker-study-for-cisplatin-ineligible-patients-receiving-chemoradiotherapy-with-docetaxel-100588919",false,"NCT06947668","Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel","DoIT_Neck","Inclusion Criteria:\n\n* Patients with squamous cell carcinomas of the oropharynx, larynx and oral cavity for whom definitive or postoperative chemoradiation is indicated\n* Patients who are cisplatin-unfit for chemotherapy, defined as:\n\n  * ECOG 2\n  * Organ dysfunction ≥ 2 according to National Cancer Institute Common Toxicity Criteria (NCI CTC) Version 4.0, such as hearing loss or tinnitus or neurological diseases\n  * Calculated creatinine clearance of ≤50ml\u002Fmin\n  * Impaired organ function or comorbidities that preclude the use of cisplatin, e.g.: left ventricular ejection fraction \\\u003C 50%, uncorrectable renal insufficiency with elevated creatinine despite creatinine clearance of 50ml\u002Fmin due to increased body weight, uncontrolled hypertension\n  * Poor nutritional status BMI \\\u003C 16kg\u002Fm²\n  * Concomitant use of nephrotoxic drugs that cannot be discontinued or converted due to other illnesses.\n  * Willingness of patients to provide blood, saliva and stool samples and consent to the preservation of all samples for study purposes\n  * Age ≥ 18 years\n  * Sufficient cognitive abilities of the patients to understand the purpose of the study and to consent to it\n\nExclusion Criteria:\n\n* Distant metastases at the time of diagnosis and simultaneous second cancers, i.e. at the time of study inclusion\n* Malignancies in the last 5 years regardless of location (except basal cell carcinoma or cervical uteri)\n* Carcinomas in which no sample collection is possible or likely without compromising the pathological assessment\n* Persistent drug or medication abuse\n* Patients who are unwilling or unable to comply with the protocol and receive treatment\n* Patients who are unsuitable for participation in the study due to a language barrier","ALL","18 Years",{"count":19,"type":20},250,"ESTIMATED","OBSERVATIONAL","Analysis of tumor tissue (which is already available in pathology) and collection of saliva\u002Fstool and blood samples, which are obtained as part of a routine collection. These will be evaluated together with the patients' clinical data to identify possible predictors for treatment feasibility, survival, tumor control and potentially increased tumor immunogenicity by docetaxel.",[24,25,26,27],"Squamous Cell Carcinoma of Oropharynx","Squamous Cell Carcinoma of the Hypopharynx","Larynx Squamous Cell Carcinoma","Oral Cavity Squamous Cell Carcinoma","RECRUITING","2026-03-11",{"date":31,"type":32},"2026-03-12","ACTUAL",{"date":34,"type":32},"2025-05-01",{"date":36,"type":20},"2030-12-31",{"name":38,"class":39},"University of Erlangen-Nürnberg Medical School","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":66,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"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":49,"type":20},40,"INTERVENTIONAL",[52],"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).",[55,56,57,58,59,60,61,62,63,64,26,65],"Squamous Cell Carcinoma of Head and Neck","Sinus Cancer","Nasal Cavity Cancer","Oral Cavity Cancer","Oropharynx Cancer","Hypopharynx Cancer","Larynx Cancer","Oral Squamous Cell Carcinoma","Oropharynx Squamous Cell Carcinoma","Hypopharynx Squamous Cell Carcinoma","HPV Positive Oropharyngeal Squamous Cell Carcinoma",[55,56,57,58,59,60,61,62,63,64,26,65,67,68,69],"Sacituzumab Govitecan","25-094","Memorial Sloan Kettering Cancer Center","2026-02-17",{"date":72,"type":32},"2026-02-19",{"date":74,"type":32},"2025-07-02",{"date":76,"type":20},"2028-01-02",{"name":69,"class":39},7,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":50,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":40},"100606849","proactive-risk-based-optimization--notifications-for-treatment--outcomes-in-head--neck-cancer-100606849","NCT07180901","Proactive Risk-based Optimization & Notifications for Treatment & Outcomes in Head & Neck Cancer","Proactive Risk-based Optimization & Notifications for Treatment & Outcomes (PRONTO) in Head & Neck Cancer: A Strategy to Reduce Delays From Surgery to Post-Operative Adjuvant Therapy in Head and Neck Cancer","PRONTO-HN","Inclusion Criteria:\n\n* All adult patients (age 18 or older).\n* Pathologically confirmed oral cavity or laryngeal squamous cell carcinoma.\n* Diagnosed from July 2024 to September 2026.\n* With planned primary intention surgical resection.\n* With or without adjuvant therapy.\n* Treated at the Centre Hospitalier de l'Université de Montréal.\n\nExclusion Criteria:\n\n* Patients who do not end up receiving surgery.\n* S-PORT \\> 180 days",{"count":88,"type":20},85,[90],"NA","Delays between surgery and the initiation of post-operative radiotherapy (S-PORT) in head and neck cancer (HNC) patients are prevalent and associated with worse oncologic outcomes. This pilot study evaluates whether a proactive, automated care coordination system (PRONTO-HN) can improve adherence to recommended S-PORT intervals of ≤42 days at the Centre hospitalier de l'Université de Montréal (CHUM).\n\nThe study is a single-center, quasi-experimental, interrupted time-series design with two phases. Group A (control) includes patients treated before the intervention (using a prospectively maintained database from August 2024 to August 2025). Group B (intervention) includes patients treated with the new coordination system from September 2025 to September 2026.\n\nThe intervention includes automated alerts, multidisciplinary task coordination, and risk stratification based on a predictive model developed and published by our team. This model uses only pre-operative data to estimate the likelihood that a patient will require adjuvant therapy after surgery, stratifying patients into high- and low-risk categories. High-risk patients receive intensified coordination protocols, including early oncology and dental consultations and shorter target times for pathology results.\n\nPrimary objective: Reduce the proportion of patients with S-PORT \\> 42 days. Secondary\u002Ftertiary objectives: Reduce mean S-PORT time. Evaluate impacts on overall, locoregional, and disease-free survival in a 2- and 3-year follow up study.\n\nPatients are identified at the time the operating room request is submitted. Demographic, clinical, and oncologic data are collected and stored securely in REDCap. As the intervention is administrative in nature and does not modify patient care, consent is waived.\n\nStatistical analysis will evaluate the intervention's effect and identify predictors of delays. A sample of 38 patients per group provides adequate power to detect a drop in S-PORT \\> 42 days from 80% to 50%.",[93,94,26],"Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer","Head &Amp;Amp; Neck Squamous Cell Carcinoma",[96,97,98],"Surgery to post-operative radiation therapy interval","Treatment delays","Oral cavity cancer","2025-09-11",{"date":101,"type":32},"2025-09-18",{"date":103,"type":32},"2025-08-21",{"date":105,"type":20},"2029-10-21",{"name":107,"class":39},"Centre hospitalier de l'Université de Montréal (CHUM)"]