[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oral-cavity-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oral-cavity-cancer":55},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,100,129,165,185,217,251,275,299,324,351,381,406,429],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":77,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100210159","integrated-cancer-repository-for-cancer-research-100210159",false,"NCT02012699","Integrated Cancer Repository for Cancer Research","iCaRe2","Inclusion Criteria\n\n* Diagnosis\u002Fhistory of cancer\n* Risk for developing cancer or suspicious clinical findings\n* No history of cancer (normal control registry)\n* Able to provide informed consent\n* 19 years of age or older\n* English or Spanish speaking individuals\n\nExclusion Criteria\n\n* Unable to provide informed consent because of cognitive impairment\n* Non-English or non-Spanish speaking individuals",true,"ALL","19 Years","110 Years",{"count":21,"type":22},999999,"ESTIMATED","80 Years","OBSERVATIONAL","The iCaRe2 is a multi-institutional resource created and maintained by the Fred \\& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76],"Pancreatic Cancer","Thyroid Cancer","Lung Cancer","Esophageal Cancer","Thymus Cancer","Colon Cancer","Rectal Cancer","Gastrointestinal Stromal Tumors","Anal Cancer","Bile Duct Cancer","Duodenal Cancer","Gallbladder Cancer","Gastric Cancer","Liver Cancer","Small Intestine Cancer","Peritoneal Surface Malignancies","Familial Adenomatous Polyposis","Lynch Syndrome","Bladder Cancer","Kidney Cancer","Penile Cancer","Prostate Cancer","Testicular Cancer","Ureter Cancer","Urethral Cancer","Hypopharyngeal Cancer","Laryngeal Cancer","Lip Cancer","Oral Cavity Cancer","Nasopharyngeal Cancer","Oropharyngeal Cancer","Paranasal Sinus Cancer","Nasal Cavity Cancer","Salivary Gland Cancer","Skin Cancer","Central Nervous System Tumor","Central Nervous System Cancer","Mesothelioma","Breast Cancer","Leukemia","Melanoma","Sarcoma","Unknown Primary Tumor","Multiple Myeloma","Ovarian Cancer","Endometrial Cancer","Vaginal Cancer","Neuroendocrine Tumors","Plasma Cell Dyscrasia","Healthy Control",[27,28,78,79,80,81,82,83,84,85,65,86,75,76],"Esophageal cancer","Thymus cancer","Pancreatic tumor","Esophageal tumor","Thymus tumor","Thyroid Tumor","Thyroid Nodule","Lung Tumor","Neuroendocrine tumor","RECRUITING","2026-06-25",{"date":90,"type":91},"2026-06-29","ACTUAL",{"date":93,"type":91},"2013-11-01",{"date":95,"type":22},"2099-12",{"name":97,"class":98},"University of Nebraska","OTHER",42,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"100472224","mandibular-reconstruction-preplanning-vipmr-100472224","NCT05429099","Mandibular Reconstruction Preplanning (ViPMR)","Virtual Preplanning of Mandibular Reconstruction (ViPMR): a Phase III Randomized Controlled Clinical Trial","ViPMR","Inclusion Criteria:\n\n* primary diagnosis requiring mandibulectomy and fibular or scapular free flap reconstructive surgery\n* are over the age of 18\n* cognitive ability and language skills that allow participation in the trial\n* provide informed consent\n\nExclusion Criteria:\n\n* severe comorbidities including metastatic disease\n* do not have a recent (within 30 days) CT scan and are unable\u002Funwilling to receive a head CT scan at the latest 6 days prior to surgery\n* prior history of head or neck cancer within last 5 years\n* prior history of head or neck radiation treatment at any time\n* pregnant of lactating women","18 Years",{"count":110,"type":22},420,"INTERVENTIONAL",[113],"NA","Virtual Surgical Planning (VSP), where 3D modeling is used to create 3D-printed surgical guides, has been shown to improve outcomes for patients who undergo mandibular reconstruction surgery, usually due to invasion of cancer from the oral cavity to the jaw. This trial will directly compare the outcomes of patients who receive VSP versus patients who receive the current standard of care, which is Free-Hand Surgery (FHS). They will be randomized into either treatment at a 1:1 ratio and bony union rates will be compared between 12-month postoperative CT scans for each treatment group. Secondary objectives include comparing other short and long-term complication rates, reconstruction accuracy, quality of life, and functional outcomes of VSP and FHS. An economic analysis of VSP will also be performed.",[55,116],"Oral Cancer",[55,116,118],"Mandibular Reconstruction","2026-05-28",{"date":121,"type":91},"2026-06-01",{"date":123,"type":91},"2022-10-15",{"date":125,"type":22},"2028-10-15",{"name":127,"class":98},"University of British Columbia",1,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":111,"phases":139,"briefSummary":141,"conditions":142,"keywords":149,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":128},"100609025","phase-2-neoadjuvant-chemotherapy-and-programmed-cell-death-protein-1pd-1-inhibition-for-head-and-neck-cancer-treatment-de-escalation-neoscorch-hn-100609025","NCT07209189","Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-escalation (NeoScorch HN)","Neoadjuvant Chemotherapy and PD-1 Inhibition for Head and Neck Cancer Treatment De-escalation (NeoScorch HN)","(NeoScorch HN)","Inclusion:\n\n* Eligible subjects must have histologically confirmed, locoregionally advanced head and neck or sinonasal, nasolacrimal, or skull base tumors and meet HPV testing requirements as outlined.\n* HPV-independent HNSCC (cT2-cT4, N0-N3) with potential for organ preservation using response-adapted surgery.\n* HPV-associated HNSCC with radiographic extranodal extension (cT1-cT3 tonsil or lateralized base of tongue, N0-N1, up to 4 nodes with rENE).\n* Sinonasal\u002Fskull base tumors, including: sinonasal carcinomas, HPV-associated sinonasal cancer, sinonasal undifferentiated carcinoma (e.g., Isocitrate dehydrogenase 2 (IDH2) mutant), or neuroendocrine sinonasal tumors (e.g., olfactory neuroblastoma) (cT2-cT4, N0-N3).\n* HPV16 type only. Patients with non-HPV16 cancers are not eligible. If p16 immunohistohemistry (IHC) positivity is the only result available at enrollment, neoadjuvant therapy may start while HPV nucleic acid testing is pending. Patients found to be HPV non-16 must discontinue study participation.\n* At least 8 unstained 5-µm slides must be available. If unavailable, a new biopsy is required unless waived by the PI.\n* Appropriate candidates for curative-intent therapy.\n* American Joint Committee on Cancer (AJCC) 7th edition: Stage III-IV, excluding N2c or bulky N2b\u002Fc (N3 equivalent) and bulky T4 (≥30cc).\n* AJCC 8th edition: Stage I with N1, Stage II, or Stage III, excluding N2 disease, bulky nodal disease (N3 equivalent), or bulky T4 (≥30cc).\n* Surgical arm: Candidates must be operable based on upfront imaging\u002Fexam. Patients with Grade 1 rENE may proceed to surgery; Grade 2\u002F3 rENE are excluded.\n* Measurable disease per RECIST 1.1.\n* No prior systemic therapy, radiotherapy, or investigational agents for the current cancer.\n* No complete surgical resection within 8 weeks of enrollment (biopsy or excision with residual disease acceptable).\n* Eastern Cooperative Oncology Group (ECOG) 0-1 or Karnofsky ≥70%.\n* Platelets ≥100,000\u002FµL.\n* Absolute Neutrophil Count (ANC) ≥1,500\u002FµL.\n* Hemoglobin ≥9 g\u002FdL (without recent transfusion\u002FEPO).\n* Aspartate Aminotransferase (AST)\u002F Alanine Aminotransferase (ALT) \\\u003C2.5 × ULN.\n* Albumin ≥2.5 mg\u002FdL.\n* Total bilirubin ≤1.5 × ULN or direct bilirubin ≤ULN if total \\>1.5 × ULN (Upper Limit of Normal).\n* Creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault or measured GFR).\n* International Normalized Ratio (INR)\u002F Prothrombin Time (PT) ≤1.5 × ULN (unless on anticoagulants; must be within therapeutic range).\n* Activated Partial Thromboplastin Time (aPTT) ≤1.5 × ULN (unless on anticoagulants; must be within therapeutic range).\n* Must sign and understand a study-specific informed consent form.\n* Women of childbearing potential (WOCBP): Negative pregnancy test within 72 hours prior to first dose.\n* WOCBP must not be breastfeeding and must agree to use highly effective contraception during therapy and for 120 days after last dose.\n* Men: Must use adequate contraception during treatment and for 120 days after last dose; condom use required in addition to highly effective methods.\n* Azoospermic men and WOCBP not heterosexually active are exempt from contraception but must still undergo pregnancy testing.\n* Counseling on pregnancy prevention is mandatory.\n* Highly effective methods (\\\u003C1% failure rate with consistent use) must be used\n\nExclusion:\n\n* WOCBP with a positive urine pregnancy test within 72 hours before treatment allocation; if positive or inconclusive, a confirmatory serum pregnancy test is required.\n* Pregnant or breastfeeding, or planning to conceive or father a child during the study and for 120 days after the last dose.\n* Prior treatment with PD-1, PD-L1, PD-L2 inhibitors, or other agents targeting T-cell receptors (e.g., Cytotoxic T-lymphocyte antigen 4 (CTLA-4), OX40 (Tumor Necrosis Factor Receptor Superfamily Member 4), CD137).\n* Prior systemic anti-cancer therapy or radiotherapy for the current cancer. Surgery is allowed if adequately recovered from complications.\n* Radiotherapy within 2 weeks of study start. A 1-week washout is permitted for palliative, non-stereotactic radiation (≤2 weeks) to non-Central Nervous System (CNS), non-head and neck disease, provided there are no residual toxicities, no steroid requirement, and no history of radiation pneumonitis.\n* Live or live-attenuated vaccines within 30 days of first study dose (including live Corona Virus Disease (COVID-19) vaccines). Inactivated, Messenger ribonucleic acid (mRNA), and peptide vaccines are allowed.\n* Concurrent treatment with other investigational agents.\n* Participation in another investigational drug or device study within 4 weeks before first study dose, unless in follow-up phase only.\n* Diagnosis of immunodeficiency, or receiving chronic systemic steroids at doses \\>10 mg prednisone equivalent daily, or other immunosuppressive therapy within 7 days before study drug.\n* Active autoimmune disease requiring systemic treatment in the past 2 years. Physiologic replacement therapy (thyroxine, insulin, low-dose steroids for adrenal or pituitary insufficiency) is allowed.\n* History of severe hypersensitivity (≥Grade 3) to Toripalimab, its excipients, or other anti-PD-1 agents.\n* Additional active malignancy requiring treatment within 2 years, except basal\u002Fsquamous cell skin cancers, in situ cancers, low-grade tumors unlikely to affect survival within 3 years, or cancers treated with curative therapy.\n* Active CNS metastases or carcinomatous meningitis. Intracranial extension of the primary tumor is allowed. Patients with previously treated brain metastases may enroll if radiologically stable ≥4 weeks, clinically stable, and off steroids ≥14 days before study drug.\n* History of pneumonitis or interstitial lung disease requiring steroids, or current pneumonitis\u002FInterstitial Lung Disease (ILD).\n* Active infection requiring systemic therapy.\n* Known HIV infection.\n* Known active Hepatitis B (HBsAg positive) or active Hepatitis C (HCV RNA positive). Patients with cleared or eradicated Hepatitis B (HBV) or HCV are eligible.\n* Any condition, therapy, or abnormality that could confound study results, interfere with participation, or be judged by the investigator as not in the participant's best interest.\n* Known psychiatric illness or substance abuse that could interfere with study compliance. Stable chronic managed disorders are acceptable.\n* History of allogeneic tissue or solid organ transplant.\n* Significant cardiovascular disease, including congestive heart failure (NYHA Class III or IV), unstable angina, serious uncontrolled arrhythmia, myocardial infarction within 6 months, or prior myocarditis.",{"count":138,"type":22},75,[140],"PHASE2","The NeoScorch HN study is a single institution multisite phase II trial including 3 cohorts of 25 patients each for patients with newly diagnosed locoregionally advanced, histologically confirmed, head and neck cancer eligible for curative-intent treatment, who will receive neo-adjuvant chemoimmunotherapy-based treatment as well as standard of care adjuvant treatment. The three cohorts include three different aspects of surgical de-escalation in head and neck cancer. The first cohort includes human papillomavirus independent (HPV-) squamous cell carcinoma of the head and neck. The second cohort includes HPV-associated head and neck cancer with radiographic evidence of extranodal extension in neck lymphadenopathy. The third cohort specifically includes malignancies of the sinonasal cavity and skull base which have a propensity for invasion of the orbit, skull base, and maxilla. Surgical treatment of all three of these cohorts has significant morbidity including swallowing, speech, and vision among others.",[143,144,55,57,53,145,146,147,148],"Head and Neck Cancer","Squamous Cell Carcinoma","Sinonasal Squamous Cell Carcinoma","HPV (Human Papillomavirus)-Associated Carcinoma","Skull Base Tumors","HPV 16 Positive Oropharyngeal Tumors (OPC)",[150,151,152,153,154,155],"head and neck cancer","oral cancer","oropharyngeal cancer","laryngeal cancer","HPV associated","squamous cell carcinoma","2026-04-21",{"date":158,"type":91},"2026-04-23",{"date":160,"type":91},"2026-02-18",{"date":162,"type":22},"2030-12-01",{"name":164,"class":98},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":111,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":128},"100619359","study-to-identify-biomarkers-of-oral-cavity-cancer-response-to-neoadjuvant-immunotherapy-prior-to-definitive-surgery-100619359","NCT07343596","Study to Identify Biomarkers of Oral Cavity Cancer Response to Neoadjuvant Immunotherapy Prior to Definitive Surgery","Inclusion Criteria:\n\n* Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately\n* Age 18 years and older at the time of registration consent\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 within 30 days prior to enrollment\n* Suspected clinical American Joint Committee on Cancer (AJCC) 8th edition stage II-IVB (T2-T4b N0-N3) oral cavity cancer (oral tongue, floor of mouth, buccal, gingival, retromolar trigone, lip, hard palate) amenable to surgical resection. Patients will be consented prior to research biopsy.\n* Primary tumor of at least 2 cm which is amenable to a 250 mm3 (e.g.10 mm x 5 mm x 5 mm) research biopsy, equivalent to one-two forceps biopsies.\n* Patients may not have received prior chemotherapy or immunotherapy for the oral cavity malignancy. Patients must have completed other cancer therapies unrelated to their oral cavity cancer greater than 30 days prior to enrollment.\n* Participants of childbearing potential must agree to contraception during and for 100 days after study therapy.\n* Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to treatment. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for \\> 12 consecutive months.\n* Demonstrate adequate organ function\n\nExclusion Criteria:\n\n* Subjects with a diagnosed auto-immune disease (exceptions: subjects with controlled diabetes mellitus type I, thyroid disease, rheumatoid arthritis, vitiligo and alopecia areata not requiring treatment with immunosuppressants are eligible)\n* Pregnant or breastfeeding\n* Known additional invasive malignancy that is active and\u002For progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease free for at least three years prior to enrollment. This excludes the index oral cavity cancer.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor.\n* Has received prior radiotherapy treatment or systemic anti-cancer therapy including investigational agents for the HNC under study prior to randomization\u002Fallocation.\n* Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Has had previous allogeneic tissue\u002Fsolid organ transplant.\n* Subjects who require systemic treatment doses of corticosteroids (prednisone equivalent greater than or equal to 10 mg daily), or other immunosuppressive drugs\n* Has radiographically detectable (even if asymptomatic and\u002For previously treated) central nervous system metastases and\u002For carcinomatous meningitis as assessed by local site investigator and radiology review\n* Has Grade 3-4 bleeding due to the underlying malignancy\n* Subjects with known human immunodeficiency virus (HIV) infection, active or chronic hepatitis B or hepatitis C infection based on medical history. No testing for HIV, Hepatitis B, or Hepatitis C is required for enrollment. Subjects cannot be positive for HBV DNA, HCV RNA, hepatitis B surface antigen, or anti-hepatitis B core antibody. Patients with Hepatitis B surface antigen negative and anti-hepatis B core antibody positive with undetectable HBV DNA by polymerase chain reaction may enroll.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study.\n* Subjects who cannot provide independent, legal, informed consent",{"count":172,"type":22},20,[113],"The goal of this clinical trial is to study whether researchers can create a patient-specific tumor system, called a culture vessel, in a timely manner and determine if it can predict how someone will respond to a specific therapy.\n\nParticipants will:\n\n* Undergo a research biopsy\n* Take pembrolizumab per standard of care prior to surgery",[55],"2026-04-20",{"date":178,"type":91},"2026-04-22",{"date":180,"type":91},"2026-04-15",{"date":182,"type":22},"2027-12",{"name":184,"class":98},"University of Wisconsin, Madison",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":192,"enrollmentInfo":193,"targetDuration":4,"studyType":111,"phases":195,"briefSummary":196,"conditions":197,"keywords":201,"overallStatus":206,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":216},"100583416","phase-2-low-cost-screening-and-image-guided-photodynamic-therapy-pdt-of-premalignant-and-malignant-oral-lesions-100583416","NCT06876038","Low-cost Screening and Image-guided Photodynamic Therapy (PDT) of Premalignant and Malignant Oral Lesions","A Comprehensive Platform for Low-cost Screening and Image-guided Photodynamic Therapy (PDT) Treatment of Pre-malignant and Malignant Oral Lesions in Low-resource Setting","Subject Inclusion Criteria\n\n1. One grossly visible OPML, with histopathologically confirmed diagnosis of moderate, severe, and carcinoma in situ measuring ≥ 10 mm in diameter.\n2. Willing and available for follow-up for at least one year and at prerequisite time intervals.\n3. All patients above the age of 18 years and willing to voluntarily give a signed informed consent.\n4. Karnofsky Performance Score above 80 or ECOG 0 or 1.\n5. The subjects meeting the following laboratory eligibility criteria during a time not older than 2 months before accrual\n\n   * Hemoglobin level above or equal to 10%\n   * WBC \\>3000\u002Fmm3\n   * Platelets count \\>100000\u002Fmm3\n   * Total bilirubin, AST (SGOT), ALT (SGPT) \\\u003C 1.5 times the Upper Limit Normal\n   * eGFR \\> 60 ml\u002Fmin\n   * Serum Creatine less than 2 times the Upper Limit of laboratory normal\n   * INR\u002F PT and PTT within laboratory normal limits\n\nExclusion criteria:\n\n1. Hypersensitivity against active substances and porphyrins.\n2. Known diagnosis of porphyria.\n3. Simultaneous use of other potentially phototoxic substances (eg; tetracyclines, sulphonamides, fluoroquinolones, hypericin extracts).\n4. Uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled cardiac and renal diseases or psychiatric illness.\n5. Subjects with inherited or acquired bleeding and clotting disorders\n6. Women who are breastfeeding\u002F have a positive urine pregnancy test or are planning their family.\n7. Patients who have taken supplements of retinol, beta carotene, vitamin E, Selenium, or other chemo-preventive therapy at least one month prior to the baseline visit.\n8. Patients with histological evidence of no dysplasia, mild dysplasia, invasive carcinoma, and any active malignant disease.\n9. Patients with behavioral and cognitive impairment.\n10. Patients who are concurrently diagnosed and undergoing treatment for other head and neck cancers.\n11. Patients with large lesions, which, in the investigator's opinion, may require reconstructive surgery after excision.\n12. The subjects, in the opinion of the Institutional Principal Investigator, are not an appropriate candidate for study participation due to alcoholism and abstinence.\n13. Patient who was in a clinical trial for 4 weeks before participation in the present trial.","65 Years",{"count":194,"type":22},65,[140],"The primary goal of this study is to see if photodynamic therapy (PDT) is effective for treatment of lesions in the oral cavity which have high risk of becoming oral cancer. PDT treatment uses a drug, called a photosensitizer, which makes the diseased cells become light-sensitive such that they are destroyed when laser light is delivered to the target lesion. In this study a new handheld device, called SITOS (a \"Screen, Image and Treat Optical System), is used. The ability of this device to simultaneously visualize the inside of the mouth and deliver laser light to the target site will be evaluated. The main questions this study seeks to answer are:\n\n* Can this treatment completely cure oral potentially malignant lesions (OPML) without need for surgery?\n* Do lesions recur after PDT treatment?\n* Is the SITOS device easy to use for the doctor and comfortable for the patient, both as an oral imaging device and as a treatment device?",[116,55,198,199,200],"Oral Leukoplakia","Oral Lichen Planus","Oral Squamous Cell Carcinoma",[202,203,204,205],"High grade dysplasia (HGD)","Severe\u002FModerate dysplasia","Carcinoma-in-situ (CIS)","Oral potentially malignant lesion (OPML)","NOT_YET_RECRUITING","2026-03-16",{"date":209,"type":91},"2026-03-19",{"date":211,"type":22},"2026-09",{"date":213,"type":22},"2028-12",{"name":215,"class":98},"University of Massachusetts, Boston",2,{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":111,"phases":226,"briefSummary":227,"conditions":228,"keywords":238,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":250},"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":225,"type":22},40,[140],"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).",[229,230,59,55,231,232,233,200,234,235,236,237],"Squamous Cell Carcinoma of Head and Neck","Sinus Cancer","Oropharynx Cancer","Hypopharynx Cancer","Larynx Cancer","Oropharynx Squamous Cell Carcinoma","Hypopharynx Squamous Cell Carcinoma","Larynx Squamous Cell Carcinoma","HPV Positive Oropharyngeal Squamous Cell Carcinoma",[229,230,59,55,231,232,233,200,234,235,236,237,239,240,241],"Sacituzumab Govitecan","25-094","Memorial Sloan Kettering Cancer Center","2026-02-17",{"date":244,"type":91},"2026-02-19",{"date":246,"type":91},"2025-07-02",{"date":248,"type":22},"2028-01-02",{"name":241,"class":98},7,{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":111,"phases":261,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":274},"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":260,"type":22},532,[113],"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?",[143,264,231,55,233],"Head and Neck Squamous Cell Carcinoma","2025-12-04",{"date":267,"type":91},"2025-12-11",{"date":269,"type":91},"2023-10-30",{"date":271,"type":22},"2028-03-30",{"name":273,"class":98},"Medical University of South Carolina",4,{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":111,"phases":283,"briefSummary":284,"conditions":285,"keywords":286,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":274},"100497482","evaluation-of-the-benefit-of-a-new-surgical-procedure-according-to-ideal-recommendations-for-orl-cancer-patients-the-external-pudendal-flap-used-as-a-new-free-flap-for-oral-cavityoropharyngeal-reconstruction-to-limit-donor-site-sequelae-100497482","NCT05757817","Evaluation of the Benefit of a New Surgical Procedure According to IDEAL Recommendations for ORL Cancer Patients: the External Pudendal Flap Used as a New Free Flap for Oral Cavity\u002FOropharyngeal Reconstruction to Limit Donor Site Sequelae","LAMBEAU STEPA","Inclusion Criteria:\n\n1. Patient with a histologically proven diagnosis of head and neck squamous cell carcinoma (HNSCC) of the oral cavity or oropharynx.\n2. Patient whose disease is classified UICC TNM stade (8th edition) : T0-4a N0\u002FN2c M0 (no distant metastasis M0).\n3. Patient whose oral cavity or oropharynx reconstruction requires a free fasciocutaneous flap according to an experienced oncology surgeon.\n4. Patient OMS 0-1.\n5. Age ≥ 18.\n6. Patient with no contraindication to surgery.\n7. Patient affiliated to a Social Health Insurance in France.\n8. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol.\n\nExclusion Criteria:\n\n1. Patient with history of prior cervical surgery and\u002For radiation to the head and neck.\n2. History of pelvic surgery and\u002For radiation to the pelvic area.\n3. Patients with a contraindication to any form of sedation.\n4. Patient with irreversible coagulopathy.\n5. Patient with a contraindication to a CT scan or an injection of iodinated contrast medium.\n6. Patient with active autoimmune disorders requiring immunosuppressive therapy, defined as receiving steroids (dose \\> 10 mg of prednisone or equivalent) or other immunosuppressive therapy.\n7. Pregnant or breastfeeding women.\n8. Patient with another co-existing malignancy at the time of inclusion or any other significant medical, psychiatric, or surgical condition currently not controlled by treatment, which may interfere with the conduct of the study.\n9. Patient with diabetes (type 1 or 2).\n10. Patient with a BMI \\> 30kg\u002Fm².\n11. Any psychological, family, geographic or sociological condition that does not allow for compliance with the medical follow-up and\u002For procedures provided for in the study protocol .\n12. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).",{"count":225,"type":22},[113],"This is a phase 1b, multicenter, non-randomized prospective study involving an innovation phase (IDEAL-1) followed by a prospective development phase (IDEAL-2A) designed to evaluate the safety and feasibility of oral\u002Foropharyngeal reconstruction with the external pudendal free flap in two groups of patients.\n\nA maximum of 40 patients (20 patients per group) will be included in this IDEAL-1\u002F2A phase study.\n\nStage IDEAL-1: Innovation phase. The main objective is to evaluate the feasibility in terms of limiting surgical complications of a STEPA flap reconstruction in two groups of patients (Cohort: Male, Female).\n\nStage IDEAL-2A: Prospective development phase. The main objective is to describe the complication profile of the surgical procedure in these two patient populations.\n\nEach patient will be followed during 12 months after the end of complete treatment (surgery ± adjuvant treatment).\n\nA complementary study (observational study) of 250 patients will also be conducted to evaluate the acceptability of the technique (reconstruction by external pudendal flap) by the patients and to describe the factors associated with this acceptability.",[143,55,231],[143,55,231,287,288,289],"STEPA flap","Oropharyngeal or oral cavity reconstruction","IDEAL Recommendations","2025-09-11",{"date":292,"type":91},"2025-09-15",{"date":294,"type":91},"2023-11-08",{"date":296,"type":22},"2027-01",{"name":298,"class":98},"Institut Claudius Regaud",{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":111,"phases":308,"briefSummary":309,"conditions":310,"keywords":312,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":128},"100496116","radial-forearm-donor-site-closure-100496116","NCT05740033","Radial Forearm Donor Site Closure","Functional and Aesthetic Outcomes of Radial Forearm Free Flap Closure Using Split-Thickness Skin Graft vs Primary Closure; a Randomized Control Trial","Inclusion Criteria:\n\n* Adults aged 18 or older\n* Oral cavity disease (malignant or benign) requiring radial forearm free flap reconstruction\n\nExclusion Criteria:\n\n* Serious medical comorbidities including metastatic disease or other contraindications to surgery\n* Any pre-existing condition affecting the use of both hands, including previous major scars\n* Unable or unwilling to complete post-operative questionnaires in English\n* Pregnant or lactating women",{"count":307,"type":22},120,[113],"The radial forearm free flap (RFFF) is widely used in head and neck reconstruction. Its thinness, pliability, pedicle length, and vessel size are particularly suited for oropharyngeal and oral cavity reconstruction. Concerns about aesthetic and functional morbidity at the donor site have given rise to various techniques of closing the donor site, two of which are the split-thickness skin graft (STSG), taken from the thigh, and the hatchet flap, which uses a local flap within the radial forearm. This RCT will determine whether retrospectively reported improvements to aesthetic and functional outcomes for STSG patients are greater compared to hatchet flap patients.",[116,55,311],"Donor Site Complication",[116,55,313,314,315],"Radial Forearm","Donor Site","Surgical Complications","2025-06-09",{"date":318,"type":91},"2025-06-12",{"date":320,"type":91},"2023-02-01",{"date":322,"type":22},"2025-12",{"name":127,"class":98},{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":331,"enrollmentInfo":332,"targetDuration":4,"studyType":111,"phases":334,"briefSummary":335,"conditions":336,"keywords":337,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":350},"100424624","gross-examinations-versus-frozen-section-for-assessment-of-surgical-margins-in-oral-cancers-100424624","NCT04809324","Gross Examinations Versus Frozen Section for Assessment of Surgical Margins in Oral Cancers","Intra-operative Gross Examination Versus Frozen Section for Achievement of Adequate Margin in Patients Undergoing Surgery for Oral Cavity Squamous Cell Carcinoma: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Biopsy proven treatment naïve cases of OCSCC who are planned for curative surgery with en-bloc removal of the tumor with adequate margin\n2. In detail assessment of the primary tumor is possible pre-operatively\n3. Written informed consent\n4. Age more than 18 years\n\nExclusion Criteria:\n\n1. Multifocal disease\n2. Clinically evident field cancerization\n3. Previous treatment for oral cavity cancer - Surgery \u002Fchemo or radiotherapy -","100 Years",{"count":333,"type":22},1206,[113],"Surgical margin is a significant prognostic factor in oral cavity squamous cell carcinoma (OCSCC)\\[1,2,3\\]. Intra-operative frozen section (FS) has been routinely used by the surgeons to achieve adequate surgical margins. However published literature has failed to show a conclusive benefit of FS in improving oncological outcomes(4-7). The overall identification rate of the inadequate margins by FS is variable with figures in the literature ranging from25-34%.(8-10)\n\nRevision of margins based on FS is widely practiced in centers where facility for FS is available. However this has not shown to significantly improve local control when compared to cases in which FS was not utilized , in a comparative study done at Tata memorial Hospital(TMH) (5) More-over FS is a costly procedure, and sparsely available in resource- poor countries. In a recently conducted retrospective study of 1237 patients conducted at TMH, the cost benefit ratio of FS for assessment of margin is as low as 12:1(11). In another prospective study performed at the same center , investigators found that gross examination (GE) of margins by the surgeons was as effective as FS, and achievement of gross 7mm margin all around the tumor obviated the need for FS (12). In a recent meta-analysis of 8 studies that looked at the utility of frozen section and had uniformity in frozen section analysis and definition of close margins, they concluded that revision of margins based on FS does not improve oncological outcomes and further prospective studies are needed to explore this contentious issue (13). With this background, a prospective RCT is planned to explore if gross examination by surgeon and subsequent revision of margin (if necessary) is an equally effective alternative to Frozen section based revision in a randomized controlled trial.",[55],[338,339,340],"Oral squamous Cell carcinoma","frozen section","local recurrence","2025-04-08",{"date":343,"type":91},"2025-04-11",{"date":345,"type":91},"2021-11-15",{"date":347,"type":22},"2028-06",{"name":349,"class":98},"Dr.Pankaj Chaturvedi",3,{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":11,"sex":17,"minAge":192,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":360,"conditions":361,"keywords":363,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":380},"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",{"count":359,"type":22},1500,"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.",[362,55,231,232,233],"HNSCC",[364,365,366,367,368,369,370],"Elderly","Radiotherapy","Chemotherapy","Chemoradiotherapy","Cisplatin","Cetuximab","Real-world data","2025-03-24",{"date":373,"type":91},"2025-03-25",{"date":375,"type":91},"2021-06-01",{"date":377,"type":22},"2026-12-31",{"name":379,"class":98},"University Hospital Freiburg",18,{"id":382,"slug":383,"hasResults":11,"nctId":384,"briefTitle":385,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":387,"targetDuration":389,"studyType":24,"phases":4,"briefSummary":390,"conditions":391,"keywords":394,"overallStatus":206,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":128},"100547407","dysphagia-and-quality-of-life-in-patients-with-oral-squamous-cell-carcinoma-before-and-after-treatment-100547407","NCT06407570","Dysphagia and Quality of Life in Patients With Oral Squamous Cell Carcinoma Before and After Treatment","Inclusion Criteria:\n\n* Histologically confirmed squamous cell carcinoma with any location in the oral cavity including recurrences. Patients will only be included once\n* Treatment with curative intent (surgery and\u002For (chemo)radio therapy)\n\nExclusion Criteria:\n\n* Allergy to barium contrast\n* Pregnancy or breastfeeding\n* Inability or unwillingness to complete questionnaires and undergo examinations",{"count":388,"type":22},100,"12 Months","While the group of oral cavity cancer (OCC) survivors continue to increase, surgeons and oncologist intensify their search for improved treatment and rehabilitation methods to reduce the morbidity of management without compromising the oncological safety. The predominant problem after treatment of OCC is dysphagia, which is associated with malnutrition, aspiration pneumonia, hospital re-admission, and reduced quality of life (QoL) and survival.\n\nIn a pilot study, the investigators found that 45% of OCC patients reported significant eating disabilities two years after surgical treatment. However, the international literature is limited on the dysphagia and QoL of OCC survivors.\n\nWith an overall goal to improve the QoL and health status in patients treated for OCC, the present study aims to\n\n1. systematically evaluate the swallowing function before and after treatment,\n2. investigate the impact of swallowing function on QoL,\n3. identify risk factors for dysphagia,\n4. investigate if swallowing function is an independent factor for the number of ´days alive and out of hospital´\n5. evaluate the rehabilitation offered to OCC patients in Danish municipalities and the effect on swallowing outcomes.\n\nOne hundred patients treated for OCC will be included prospectively during a 2-year period. Data on type and location of tumour, treatment modality, complications, patient weight, dietary intake, rehabilitation program, hospital admissions, recurrences, and survival will be collected. Questionnaires and Modified Barium Swallow Study (MBSS) will be performed before and 2 and 12 months after treatment.",[55,392,393],"Dysphagia","Quality of Life",[55,392,393,395,396],"Days alive and out of hospital","Rehabilitation","2024-05-07",{"date":399,"type":91},"2024-05-09",{"date":401,"type":22},"2024-06-01",{"date":403,"type":22},"2028-01-01",{"name":405,"class":98},"University of Aarhus",{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":415,"conditions":416,"keywords":417,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":350},"100468091","immune-biomarker-study-for-head-and-neck-cancer-100468091","NCT05375266","Immune Biomarker Study for Head and Neck Cancer","ImmunBio-KHT","Inclusion Criteria:\n\n* Initial diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, paranasal sinuses or larynx in stage UICC II-IVB (study group)\n* Diseases other than malignant diseases (patients with the indication for surgery of the ear, nose nose or maxillofacial surgery) (control group)\n* Absence of a currently existing or previous malignant disease regardless of the anatomical localization (control group)\n* Agreement of the patients for sampling blood, saliva and stool as well as consent to the preservation of all samples for further study purposes\n* Age ≥ 18 years\n* Cognitive ability of the patients to understand the meaning and purpose of the study and agree to it\n\nExclusion Criteria:\n\n* Distant metastases and \u002F or simultaneous secondary carcinoma at the time of diagnosis (= inclusion date)\n* Carcinomas in which it is (likely) impossible to take a sample without interfering with the further pathological assessment\n* Present drug abuse\n* Patients who are unable or unwilling to behave and receive treatment according to protocol\n* Patients who are legally patronized\n* Patients who are not eligible for participation in the study due to language barrier",{"count":414,"type":22},1100,"The aim of this prospective non-interventional multi-center trial is to study the prognostic value of intratumoral and systemic immune biomarkers in newly diagnosed non-metastatic head and neck cancer. Furthermore, the local immunological processes in the tumor will be correlated with the systemic immune status determined in the peripheral blood to identify prognostic immune signatures. In addition, tumor organoids will be generated ex vivo for functional biological analyses. The main objective is to create a prognostic score determined by clusters based on tumor immunologic criteria.",[143,55,57,52,53],[418,419],"Immunologic markers","Immunotherapy","2023-05-16",{"date":422,"type":91},"2023-05-17",{"date":424,"type":91},"2022-05-16",{"date":426,"type":22},"2027-03-31",{"name":428,"class":98},"University of Erlangen-Nürnberg Medical School",{"id":430,"slug":431,"hasResults":11,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":16,"sex":17,"minAge":437,"maxAge":438,"enrollmentInfo":439,"targetDuration":4,"studyType":111,"phases":440,"briefSummary":441,"conditions":442,"keywords":443,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":457,"locationsCount":216},"100206033","screening-for-cancers-in-the-oral-cavity-100206033","NCT01958762","Screening for Cancers in the Oral CAvity","Screening for Cancers in the Oral CAvity Targeting Tobacco Users in Somme, France","IDECAB","Inclusion Criteria:\n\n* Any smoker who buys a pack of cigarettes over a period of two weeks in a tobacco shop located on the territory of the Somme\n* lives in somme departement\n\nExclusion Criteria:\n\n\\-","30 Years","75 Years",{"count":388,"type":22},[113],"In the Somme region of France, cancer registry data showed an increasing incidence of oral cancer. The Incidence Rates in Somme as compared to the national rates for Lip, Oral Cavity and Pharynx Cancer were in 2010: 31,4\u002F100 000 Standard population versus 18,2 \u002F100 000 for male and 8,2\u002F100 000 versus 5,5\u002F100 000 for female, disaster area where action to improve early detection for smokers will be assessed. This target population consults late (as 70% of oral cavity cancers are diagnosed at a late stage (T3 or T4). This project is an innovative incentive strategy for screening among general practitioners based on unusual information vectors (tobacconist, local media).\n\nThe main objective of this study is a screening of oral cavity cancers in tobacco users aged 30-75 years in the Somme region of France.",[55],[444,445,446,447,448,449,450],"Screening","Cancer","Tobacco","General Practitioner","Precancerous Lesion","Dysplasia","Tobacco vendor","2023-02-07",{"date":453,"type":91},"2023-02-08",{"date":455,"type":4},"2013-10",{"date":213,"type":22},{"name":458,"class":98},"Centre Hospitalier Universitaire, Amiens"]