[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"head-and-neck-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:head-and-neck-carcinoma":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,101,129,154,176,202,247,265,293,320,348,370,398,426,453,477,501,568,591,612,639,660],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":100},"100464928","collecting-blood-samples-from-patients-with-and-without-cancer-to-evaluate-tests-for-early-cancer-detection-100464928",false,"NCT05334069","Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection","Blinded Reference Set for Multicancer Early Detection Blood Tests","Inclusion Criteria:\n\n* Participants with a cancer diagnosis: Documentation of disease:\n\n  * Histologic documentation: Histologically confirmed diagnosis of invasive cancer\n  * Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma\n\n    * For leukemia: Type (chronic lymphocytic leukemia \\[CLL\\], chronic myeloid leukemia \\[CML\\], acute lymphoblastic lymphoma \\[ALL\\], acute myeloid leukemia \\[AML\\])\n    * For lymphoma: Stage I-IV based on Ann Arbor staging\n    * For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS)\n  * One of the following tumor types:\n\n    * Colorectal\n    * Bladder\n    * Head and neck\n    * Hepatobiliary\n    * Lung\n    * Lymphoma\n    * Leukemia\n    * Ovary \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Pancreas \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Multiple myeloma\n    * Gastric, esophageal or gastroesophageal\n    * Breast\n    * Thyroid\n    * Kidney\n\n      * For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Endometrium\n    * Prostate\n    * Melanoma\n\n      \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Sarcoma\n* Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention\n* Participants with a cancer diagnosis: Age \\>= 40 and =\\\u003C 75\n* Participants with a cancer diagnosis: No known current pregnancy by self-report\n* Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a cancer diagnosis: Willingness to provide blood samples for research use\n* Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a cancer diagnosis: No history of organ transplantation\n* Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants without a cancer diagnosis and without suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report\n* Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers)\n* Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use\n* Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation\n* Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, or melanoma by clinical and\u002For radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw\n\n  \\* Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma\n* Participants with a high suspicion of cancer: Central review of radiology reports and\u002For clinical documentation conducted by study chairs\n* Participants with a high suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants with a high suspicion of cancer: No known current pregnancy by self-report\n* Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a high suspicion of cancer: Willingness to provide blood samples for research use\n* Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a high suspicion of cancer: No history or organ transplantation\n* Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish \\* Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages",true,"ALL","40 Years","75 Years",{"count":21,"type":22},2000,"ESTIMATED","OBSERVATIONAL","This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87],"Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Ann Arbor Stage I Lymphoma","Ann Arbor Stage II Lymphoma","Ann Arbor Stage III Lymphoma","Ann Arbor Stage IV Lymphoma","Chronic Lymphocytic Leukemia","Chronic Myeloid Leukemia","Gastroesophageal Junction Adenocarcinoma","Head and Neck Carcinoma","Hematopoietic and Lymphoid Cell Neoplasm","Invasive Breast Carcinoma","Kidney Carcinoma","Malignant Hepatobiliary Neoplasm","Malignant Solid Neoplasm","Melanoma","Muscle-Invasive Bladder Carcinoma","RISS Stage I Plasma Cell Myeloma","RISS Stage II Plasma Cell Myeloma","RISS Stage III Plasma Cell Myeloma","Sarcoma","Stage I Bladder Cancer AJCC v6 and v7","Stage I Breast Cancer AJCC v7","Stage I Colorectal Cancer AJCC v6 and v7","Stage I Esophageal Cancer AJCC V7","Stage I Gastric Cancer AJCC V7","Stage I Lung Cancer AJCC v7","Stage I Ovarian Cancer AJCC v6 and v7","Stage I Pancreatic Cancer AJCC v6 and v7","Stage I Prostate Cancer AJCC v7","Stage I Uterine Corpus Cancer AJCC v7","Stage II Bladder Cancer AJCC v6 and v7","Stage II Breast Cancer AJCC v6 and v7","Stage II Colorectal Cancer AJCC v7","Stage II Esophageal Cancer AJCC v7","Stage II Gastric Cancer AJCC v7","Stage II Lung Cancer AJCC v7","Stage II Ovarian Cancer AJCC v6 and v7","Stage II Pancreatic Cancer AJCC v6 and v7","Stage II Prostate Cancer AJCC v7","Stage II Uterine Corpus Cancer AJCC v7","Stage III Bladder Cancer AJCC v6 and v7","Stage III Breast Cancer AJCC v7","Stage III Colorectal Cancer AJCC v7","Stage III Esophageal Cancer AJCC v7","Stage III Gastric Cancer AJCC v7","Stage III Lung Cancer AJCC v7","Stage III Ovarian Cancer AJCC v6 and v7","Stage III Pancreatic Cancer AJCC v6 and v7","Stage III Prostate Cancer AJCC v7","Stage III Uterine Corpus Cancer AJCC v7","Stage IV Bladder Cancer AJCC v7","Stage IV Breast Cancer AJCC v6 and v7","Stage IV Colorectal Cancer AJCC v7","Stage IV Esophageal Cancer AJCC v7","Stage IV Gastric Cancer AJCC v7","Stage IV Lung Cancer AJCC v7","Stage IV Ovarian Cancer AJCC v6 and v7","Stage IV Pancreatic Cancer AJCC v6 and v7","Stage IV Prostate Cancer AJCC v7","Stage IV Uterine Corpus Cancer AJCC v7","Thyroid Gland Carcinoma","RECRUITING","2026-07-01",{"date":91,"type":92},"2026-07-02","ACTUAL",{"date":94,"type":92},"2022-08-18",{"date":96,"type":22},"2027-02-28",{"name":98,"class":99},"Alliance for Clinical Trials in Oncology","OTHER",745,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":111,"phases":112,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"100374101","phase-1-high-dose-steroid-therapy-prednisone-or-methylprednisolone-for-the-improvement-of-symptoms-of-late-radiation-associated-lower-cranial-neuropathy-in-oropharyngeal-cancer-survivors-100374101","NCT04151082","High Dose Steroid Therapy (Prednisone or Methylprednisolone) for the Improvement of Symptoms of Late Radiation-Associated Lower Cranial Neuropathy in Oropharyngeal Cancer Survivors","Stop LCNP: High Dose Steroid Therapy for Late Radiation-Associated Lower Cranial Neuropathy: A Phase I\u002FII Dose Finding Trial and Data Registry","Inclusion Criteria:\n\n* INCLUSION CRITERIA FOR CLINICAL TRIAL: Disease free adult survivors of oropharyngeal cancer\n* INCLUSION CRITERIA FOR CLINICAL TRIAL: Treated with radiotherapy \\>= 2 years post treatment (disease status per surveillance imaging and clinical surveillance)\n* INCLUSION CRITERIA FOR CLINICAL TRIAL: Late radiation-associated lower cranial neuropathy of XII with or without X nerve (LCNP cases will be considered therapy-related when imaging, physical examination, and\u002For biopsy fail to demonstrate structural or malignant source)\n* INCLUSION CRITERIA FOR CLINICAL TRIAL: Willing and able to return for assessment post-steroid therapy\n* INCLUSION CRITERIA FOR CLINICAL TRIAL: Able to complete symptom survey (MD Anderson Symptom Inventory - Head and Neck \\[MDASI-HN\\]) in validated languages: English, simplified Chinese, Filipino, Greek, Japanese, Korean, Russian, Spanish, Taiwanese\n* INCLUSION CRITERIA FOR REGISTRY: Disease-free adult survivors of head and neck cancer\n* INCLUSION CRITERIA FOR REGISTRY: \\>= 2 years post treatment (disease status per surveillance imaging and clinical surveillance)\n* INCLUSION CRITERIA FOR REGISTRY: Late lower cranial neuropathy of XII with or without X nerve (LCNP cases will be considered therapy-related when imaging, physical examination, and\u002For biopsy fail to demonstrate structural or malignant source)\n* INCLUSION CRITERIA FOR REGISTRY: Able to complete symptom survey (MDASI-HN) in validated languages: English, simplified Chinese, Filipino, Greek, Japanese, Korean, Russian, Spanish, Taiwanese\n\nExclusion Criteria:\n\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Uncontrolled diabetes\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Uncontrolled hypertension (systolic \\> 160; diastolic \\> 90)\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Known gastrointestinal ulcer\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: History of psychosis\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Pregnant women\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Untreated or treatment refractory obstructive pharyngoesophageal stricture\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Known history or diagnosis of bipolar disorder\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: History of surgery near hypoglossal nerve path\n* EXCLUSION CRITERIA FOR REGISTRY: Uncontrolled diabetes\n* EXCLUSION CRITERIA FOR REGISTRY: Uncontrolled hypertension (systolic \\> 160; diastolic \\> 90)\n* EXCLUSION CRITERIA FOR REGISTRY: Known gastrointestinal ulcer\n* EXCLUSION CRITERIA FOR REGISTRY: History of psychosis\n* EXCLUSION CRITERIA FOR REGISTRY: Pregnant women\n* EXCLUSION CRITERIA FOR REGISTRY: Untreated or treatment refractory obstructive pharyngoesophageal stricture\n* EXCLUSION CRITERIA FOR REGISTRY: Known history or diagnosis of bipolar disorder","18 Years",{"count":110,"type":22},35,"INTERVENTIONAL",[113,114],"PHASE1","PHASE2","This phase I\u002FII trial studies the side effect and best dose of steroid therapy (prednisone or methylprednisolone) in improving symptoms of late radiation-associated lower cranial neuropathy in oropharyngeal cancer survivors. Steroid therapy with prednisone or methylprednisolone may help to improve symptoms associated with late radiation-associated lower cranial neuropathy.",[117,35,118],"Cranial Nerve Disorder","Oropharyngeal Carcinoma","2026-06-24",{"date":121,"type":92},"2026-06-26",{"date":123,"type":92},"2019-10-16",{"date":125,"type":22},"2027-07-31",{"name":127,"class":99},"M.D. Anderson Cancer Center",1,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":128},"100132279","data-collection-for-the-assessment-of-acute-and-late-normal-tissue-in-patients-treated-with-proton-therapy-100132279","NCT00991094","Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy","Data Collection to Assess Acute and Late Normal Tissue Sequelae in Proton Therapy for Adults","Inclusion Criteria:\n\n* All patients scheduled for radiation treatment with protons at UTMDACC are eligible for this protocol\n* Patients must sign a study-specific consent form prior to study entry\n\nExclusion Criteria:\n\n* Patients who are unable or unwilling to attend the required periodic follow-ups either at M.D. Anderson or at a different site",{"count":137,"type":22},5000,"This study collects information on the side effects of proton therapy and detailed information on the proton therapy treatment plan itself. This may help researchers develop methods to predict the risk of side effects for future patients and learn the long-term benefit of proton therapy.",[140,141,142,35,36,143,144,145,40],"Breast Carcinoma","Esophageal Carcinoma","Genitourinary System Carcinoma","Lung Carcinoma","Malignant Central Nervous System Neoplasm","Malignant Digestive System Neoplasm","2026-06-10",{"date":148,"type":92},"2026-06-12",{"date":150,"type":92},"2005-05-27",{"date":152,"type":22},"2027-12-31",{"name":127,"class":99},{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":111,"phases":163,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":128},"100585002","a-financial-intervention-financial-compass-to-identify-and-address-financial-hardship-among-head-and-neck-cancer-patients-financial-compass-trial-100585002","NCT06896695","A Financial Intervention (Financial Compass) to Identify and Address Financial Hardship Among Head and Neck Cancer Patients, Financial Compass Trial","Financial Compass: A Pilot Feasibility Study of a Novel Intervention to Identify and Address Financial Hardship Among Cancer Patients","Inclusion Criteria:\n\n* They have been diagnosed with head and neck cancer\n* Screen positive for financial hardship on the validated Comprehensive Score for Financial Toxicity (COST) measure\n* Are able to participate in English or Spanish\n\nExclusion Criteria:\n\n* Adults unable to complete the process of informed consent\n* Adults whose primary language is not English or Spanish\n* Individuals who are not yet adults (i.e., infants, children, teenagers)\n* Unwilling or unable to follow protocol requirements",{"count":162,"type":22},50,[164],"NA","This clinical trial compares the effect a financial intervention, called Financial Compass, to usual care in identifying and addressing financial hardship in patients with head and neck cancer. Previous research has shown that head and neck cancer patients experiencing financial hardship have decreased overall and cancer specific survival. Using a financial intervention, Financial Compass, may be more effective than usual care in identifying and addressing financial hardship in patients with head and neck cancer.",[35],"2026-06-04",{"date":169,"type":92},"2026-06-08",{"date":171,"type":92},"2025-09-23",{"date":173,"type":22},"2027-02-25",{"name":175,"class":99},"Roswell Park Cancer Institute",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":111,"phases":185,"briefSummary":186,"conditions":187,"keywords":191,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":128},"100564291","phase-2-antibiotic-treatment-effects-on-intratumoral-bacteria-modulation-in-surgical-patients-with-oral-cancer-100564291","NCT06627270","Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer","A Phase II Single-arm Cohort Study Establishing the Effect of Antibiotic Treatment on Intratumoral Bacteria in Surgical Patients With Oral Cancer","Inclusion Criteria:\n\n* Pathologically confirmed squamous cell carcinoma of the oral cavity\n* Must have planned surgery for curative intent\n* Participants ≥ 18 years of age\n* Participants must have the ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Known allergy to metronidazole and\u002For chlorhexidine\n* Severe liver or kidney disease as determined by history of laboratory tests\n* Participants actively drinking alcohol (unable to abstain for the 10 day antibiotic period)\n* Recurrent oral cancer after prior radiation or chemoradiation\n* Participants with unresectable oral cancer\n* Participants unable to tolerate oral rinse or unable to have metronidazole administered by mouth or by feeding tube\n* Participants currently or have taken other antibiotics within the prior 30 days\n* Participant is pregnant",{"count":184,"type":22},30,[114],"The goal of this phase II single arm clinical study is to evaluate the effect of antibiotics (metronidazole) and oral chlorhexidine (CHX) in reducing the bacteria load within tumors of patients undergoing surgery for oral cancer.",[188,189,190,35],"Oral Squamous Cell Carcinoma","Oral Cancer","Head and Neck Cancer",[192,193],"Metronidazole","Chlorhexidine","2026-06-03",{"date":167,"type":92},{"date":197,"type":92},"2025-03-11",{"date":199,"type":22},"2027-10-01",{"name":201,"class":99},"Case Comprehensive Cancer Center",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":111,"phases":211,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":128},"100614857","phase-2-the-cancer-connected-access-and-remote-expertise-beyond-walls-program-to-provide-in-home-cancer-treatment-and-improve-treatment-satisfaction-in-cancer-patients-living-in-the-florida-panhandle-and-surrounding-areas-100614857","NCT07285044","The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas","Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas","Inclusion Criteria:\n\n* Patient has had adequate tolerability of their clinical standard of care treatment, in the opinion of their treating physician, and no clinically significant drug-related reactions occurred prior to consent\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) Food and Drug Administration (FDA)-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. National Comprehensive Cancer Network \\[NCCN\\], American Society of Clinical Oncology \\[ASCO\\], American Society of Hematology \\[ASH\\], etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines\n* A social stability screener, used per standard of care, indicates patient is appropriate to participate in the CCBW program\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3 at the discretion of the treating physician\n* Female or male patients age \\>= 18 years at the time of consent\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Patients with histologically confirmed malignancy who are currently receiving treatment with one of the eligible treatment regimens. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis alone: histologic confirmation is not required.\n\n  * Note: patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving hormonal or immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Co-administration with hormonal agents such as anti-androgens, poly(ADP-ribose) polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, selective estrogen receptor modulators (SERMs), or aromatase inhibitors are allowed, however combinations of oral regimens only are not permitted. Patients may receive any combination of any listed medications or regimens\n  * Eligible disease cancer types:\n\n    * Amyloidosis\n    * Basal cell carcinoma\n    * Biliary\n    * Bladder\n    * Breast\n    * Cervical\n    * Colorectal\n    * Endometrial\n    * Fallopian tube\n    * Gastroesophageal\n    * Glioblastoma\n    * Head and neck\n    * Hepatocellular\n    * Hodgkin lymphoma\n    * Lung\n    * Mantle cell lymphoma\n    * Merkle cell carcinoma\n    * Multiple myeloma\n    * Melanoma\n    * Myelodysplastic syndrome\n    * Ovarian\n    * Pancreatic\n    * Peritoneal\n    * Prostate\n    * Renal cell carcinoma\n    * Squamous cell carcinoma\n    * Urothelial carcinoma\n  * Eligible regimens\n\n    * Atezolizumab +\u002F- bevacizumab\n    * Avelumab\n    * Bevacizumab\n    * Bortezomib\n    * Cemiplimab\n    * Daratumumab +\u002F- bortezomib\n    * Darbepoetin alpha\n    * Degarelix\n    * Denosumab (Xgeva)\n    * Durvalumab\n    * Fluorouracil +\u002F- bevacizumab\n    * Fulvestrant\n    * Goserelin\n    * Ipilimumab +\u002F- Nivolumab\n    * Lanreotide\n    * Leuprolide\n    * Nivolumab\n    * Nivolumab + relatlimab\n    * Octreotide\n    * Pembrolizumab\n    * Pertuzumab +\u002F- trastuzumab\n    * Trastuzumab +\u002F- pertuzumab\n    * Zoledronic acid (Zometa)\n* Willingness to follow birth control requirements for females and males of reproductive potential\n* Resides within the Florida Panhandle and surrounding area serviced by the at-home healthcare supplier utilized for the study and a paramedic network\n* Patient's residence has an existing Wi-Fi connection or can be connected using using a mobile Wi-Fi device provided as part of the program so as to enable a reliable connection with the remote CCBW Command Center at Mayo Clinic\n* Patients who, according to documentation from their treating provider, plan to continue the eligible treatment regimen they are currently prescribed for \\>= 12 weeks from the time of registration\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nExclusion Criteria:\n\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Receiving any investigational agent which would be considered as a treatment for the primary neoplasm.\n\n  * Note: oral concomitant medications for oncologic indications will be maintained per standard of care treatment and not considered part of the trial. Any nononcologic medication, regardless of route of administration will be maintained per standard of care treatment and also not considered part of the trial; therefore, patients receiving oral anti-cancer or other medications per standard of care treatment in addition to any of the medications listed are considered eligible for this trial\n* Individuals who require continuous (24\u002F7) assistance with daily living and are unable to independently manage the technology required for study participation, unless a caregiver is available and willing to provide consistent support throughout the study\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)",{"count":210,"type":22},27,[114],"This phase II trial studies whether providing cancer treatment in the home is preferred over the traditional clinic setting and if it improves treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas. Typically, drug-related cancer care is provided at a medical center which causes patients to have to spend considerable time away from their family, friends, and familiar surroundings. This may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. The Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) program uses a specialized care team trained to provide cancer treatment in the patient's home setting. It is designed to support remote connection between the home health team and providers and Mayo clinic. This may be preferred over the traditional clinic setting which may improve treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas.",[214,215,216,217,140,218,219,220,221,222,223,35,224,225,226,143,40,227,41,228,229,230,231,232,233,234,235,236,237],"Amyloidosis","Basal Cell Carcinoma","Biliary Tract Carcinoma","Bladder Carcinoma","Cervical Carcinoma","Colorectal Carcinoma","Endometrial Carcinoma","Fallopian Tube Carcinoma","Gastroesophageal Junction Carcinoma","Glioblastoma","Hematopoietic and Lymphatic System Neoplasm","Hepatocellular Carcinoma","Hodgkin Lymphoma","Mantle Cell Lymphoma","Merkel Cell Carcinoma","Multiple Myeloma","Myelodysplastic Syndrome","Ovarian Carcinoma","Pancreatic Carcinoma","Primary Peritoneal Carcinoma","Prostate Carcinoma","Renal Cell Carcinoma","Squamous Cell Carcinoma","Urothelial Carcinoma","2026-05-15",{"date":240,"type":92},"2026-05-18",{"date":242,"type":92},"2025-12-18",{"date":244,"type":22},"2026-12-18",{"name":246,"class":99},"Mayo Clinic",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":254,"conditions":255,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":128},"100548378","an-integrative-multi-omic-characterization-of-head-and-neck-carcinogenesis-progression-and-recurrence-100548378","NCT06420219","An Integrative Multi-Omic Characterization of Head and Neck Carcinogenesis, Progression and Recurrence","Inclusion Criteria:\n\n* Diagnosis\u002Fdisease status: New diagnosis of head and neck cancer\n* Allowable type and amount of prior therapy: No prior treatment\n* Age ≥ 18 years.\n* Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Patients who have had treatment of head and neck cancer",{"count":162,"type":22},"This study evaluates the cell and biomarkers associated with the aggressive behavior of cancer.",[35],"2026-04-24",{"date":258,"type":92},"2026-04-28",{"date":260,"type":92},"2024-03-25",{"date":262,"type":22},"2029-03-25",{"name":264,"class":99},"University of Southern California",{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":128},"100543469","oropharynx-opx-biomarker-trial-100543469","NCT06356272","Oropharynx (OPX) Biomarker Trial","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Able to provide written consent\n* Groups 1-3:\n\n  * Must undergo p16 staining on biopsy for enrollment\n  * Patients with \\\u003C 70% of tumor cells positive for p16 will be considered p16 negative\n  * Must undergo HPV16 family in situ hybridization (ISH) and\u002For RNA on biopsy or surgical specimen, unless amount of tissue is too small to have conclusive HPV ISH testing done on it\n  * Willingness and intent to return in person to enrolling institution for follow-up (during the Active Monitoring Phase of the study) for at least 2 of the standard follow-up time points for a total of 3 time-points including pre-treatment. A participant who does not return in person to Mayo Clinic Rochester for every standard of care post-treatment follow up will not be considered deviating from the protocol\n* Group 4:\n\n  * Clinical suspicion or histopathologic diagnosis of head and neck cancer or neoplasm\n\n    * Primary salivary neoplasm\n    * Primary thyroid neoplasm\n    * Primary head and neck neoplasm\n    * Multi-cancer early detection (MCED) testing concerning for cancer\n* Patient has given permission to give his\u002Fher tumor\u002Ftissue\u002Fblood\u002Fsaliva sample for research testing\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Primary language: English, Spanish, Arabic\n\nExclusion Criteria:\n\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.\n* Groups 1-3:\n\n  * Other active malignancy ≤ 5 years prior to registration\n\n    * EXCEPTIONS: Non-melanotic skin cancer, non-metastatic thyroid cancer, non-metastatic prostate cancer, carcinoma-in-situ of the cervix, HPV+ oropharyngeal squamous cell carcinoma (SCC) (which can be enrolled in group 3)\n    * NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer\n  * History of any head and neck malignancy, other than the tumor for which they are being treated\n* Group 4, Cohort A, B, C:\n\n  * Other active malignancy ≤ 5 years prior to registration\n\n    * EXCEPTIONS: Non-metastatic prostate cancer, carcinoma-in-situ of the cervix, non metastatic cutaneous basal cell carcinoma\n    * NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer\n  * History of any head and neck malignancy, other than the present neoplasm\n  * Note these are clarifications of inclusion into Group 4, Cohorts D and E:\n\n    * Presence of other active malignancy or recurrent head and neck neoplasms are allowed in this arm\n    * Receipt of cancer specific therapy for other malignancy is allowed in this arm",{"count":272,"type":22},560,"The purpose of this research is to identify a biomarker that is exists when human papillomavirus (HPV) mediated oropharyngeal squamous cell carcinoma is present and does not exist when HPV mediated oropharyngeal squamous cell carcinoma is absent.",[275,276,277,278,279,280,281,35,282,283,284],"Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Metastatic Oropharyngeal Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Recurrent Oropharyngeal Squamous Cell Carcinoma","Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Head and Neck Neoplasm","Salivary Gland Neoplasms","Thyroid Gland Neoplasm","2026-04-17",{"date":287,"type":92},"2026-04-22",{"date":289,"type":92},"2019-11-15",{"date":291,"type":22},"2029-11-30",{"name":246,"class":99},{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":111,"phases":302,"briefSummary":303,"conditions":304,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":319},"100429337","phase-2-customized-3d-printed-oral-stents-during-head-and-neck-radiotherapy-100429337","NCT04870762","Customized 3D Printed Oral Stents During Head and Neck Radiotherapy","A Randomized Study of Head and Neck Radiotherapy With or Without Customized 3D Printed Oral Stents","Inclusion Criteria:\n\n* Participant is dispositioned to receive 5-7 weeks of definitive or adjuvant radiotherapy for treatment of a diagnosed head and neck malignancy\n* Age 18 or older\n* ECOG PS 0-2\n* The participant will receive either (a) radiation alone or (b) radiation with concurrent chemotherapy of any kind(s)\n* Signed study-specific consent form\n\nExclusion Criteria:\n\n* Prior head and neck radiotherapy\n* Participants is unable to fit a tongue-lateralizing or tongue-depressing stent\n* Severe trismus with an incisal opening of \\\u003C10 mm\n* Inability to comply with the study procedures\n* Participants younger than 18 years of age\n* Participants must not be pregnant\n* Cognitively impaired subjects",{"count":301,"type":22},119,[114],"This clinical trial studies the effect of customized 3 dimensional (3D) printed oral tents on patients with head and neck cancer who are receiving radiotherapy. Oral stents are made from the impression of patients' mouth and cover patients' teeth and gums during radiation therapy. A customized, 3D-printed oral stent may help to reduce mouth blisters and\u002For sores that may develop in patients while receiving head and neck radiation therapy.",[35,305,306,307,308,309,310],"Malignant Parotid Gland Neoplasm","Maxillary Sinus Carcinoma","Nasal Cavity Carcinoma","Oral Cavity Carcinoma","Tongue Carcinoma","Tonsillar Carcinoma","2026-04-10",{"date":313,"type":92},"2026-04-15",{"date":315,"type":92},"2021-05-26",{"date":317,"type":22},"2026-12-31",{"name":127,"class":99},7,{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":111,"phases":329,"briefSummary":330,"conditions":331,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":347},"100399013","cancer-genetic-testing-in-ethnic-populations-100399013","NCT04475640","Cancer Genetic Testing in Ethnic Populations","GEMINI - Cancer Genetic Testing in Ethnic Populations","Inclusion Criteria:\n\n* Patients at least 18 years of age\n* Individuals diagnosed with any solid tumor cancer including, but not limited to, gastrointestinal, breast, gynecological, genitourinary, skin, central nervous system (CNS)\u002Fbrain, head\u002Fneck, musculoskeletal or cancer of unknown primary; and presenting to Mayo Clinic (MC Arizona or MC Florida) for clinical management\u002Ftreatment; and patients receive genetic testing as described above\n* Self-identified as being from various ethnic populations including Hispanic\u002FLatino, Native American\u002FAlaskan, African American (including of African descent), Asian and other European populations\n* Blood collection is feasible (health, access and\u002For tolerability) for requested blood sample(s)\n* Individuals have agreed to participate and signed the study informed consent form\n\nExclusion Criteria:\n\n* Patients who have had prior germline genetic testing involving a 40+ gene panel within the last 24 months at Mayo Clinic and available for review by the research coordinator at time of consent\n* Past or current history of hematological cancer (including leukemias, multiple myeloma)\n* All bone marrow transplants",{"count":328,"type":22},1800,[164],"This clinical trial examines the integration of cancer genetic testing in various ethnic populations. Studying individuals and families at risk of cancer may help identify cancer genes and other persons at risk. The information from this study may provide an opportunity for cancer risk stratification and individualized screening in these ethnic populations.",[140,332,333,334,142,35,335,336,337,40,338],"Carcinoma of Unknown Primary","Central Nervous System Carcinoma","Digestive System Carcinoma","Malignant Brain Neoplasm","Malignant Female Reproductive System Neoplasm","Malignant Musculoskeletal Neoplasm","Skin Carcinoma","2026-04-01",{"date":341,"type":92},"2026-04-02",{"date":343,"type":92},"2020-01-13",{"date":345,"type":22},"2028-10-15",{"name":246,"class":99},2,{"id":349,"slug":350,"hasResults":11,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":16,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":111,"phases":358,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":361,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":366,"leadSponsor":368,"locationsCount":128},"100614657","a-new-way-to-share-radiation-therapy-plans-between-doctors-correct-trial-100614657","NCT07282444","A New Way to Share Radiation Therapy Plans Between Doctors, CORRECT Trial","Collaborative Oncology Between Radiologists and Radiation Oncologists for the Evaluation of Contoured Targets (CORRECT)","CORRECT","Inclusion Criteria:\n\n* PRACTICE: Must provide radiation therapy for ≥ 3 patients per month with lung cancer or head \\& neck cancer\n* PRACTICE: At least one radiation oncologist and one radiologist (in house, contracted, etc.) at the practice willing to participate, but may have multiple participants at the practice\n* PRACTICE: Radiation oncologist\u002Fradiologist team must use Picture Archiving and Communication System (PACS) software at this practice\n* RADIATION ONCOLOGIST (NON-PATIENT): Must have been in independent practice (i.e., performing duties without preceptor oversight) for a minimum of six months\n* RADIATION ONCOLOGIST (NON-PATIENT): Must treat lung and\u002For head \\& neck cancer patients with curative intent radiation therapy\n* RADIATION ONCOLOGIST (NON-PATIENT): Willing and able to participate in 15 minutes of mandatory virtual CORRECT training\n* RADIATION ONCOLOGIST (NON-PATIENT): Willing to participate in a 30-minute interview, if selected at the end of the study\n* RADIOLOGIST (NON-PATIENT): Must have been in independent practice (i.e., performing duties without preceptor oversight) for a minimum of six months\n* RADIOLOGIST (NON-PATIENT): Agree to review pre-treatment radiation therapy targets during the course of the study duration (approximately 12 months). Willing and able to participate in 15 minutes of mandatory virtual CORRECT training\n* RADIOLOGIST (NON-PATIENT): Willing to participate in a 30-minute interview, if selected at the end of the study\n* PATIENT: Must have any stage of clinically diagnosed lung or head \\& neck (HN) cancer\n* PATIENT: Planned treatment with curative intent definitive RT (with or without other treatments). Curative intent RT must be documented in the electronic medical record (EMR) by the treating radiation oncologist\n* PATIENT: Must be expected to be treated by a radiation oncologist participating in this study\n* PATIENT: Must be 18 years or older\n\nExclusion Criteria:\n\n* PRACTICE: Participation by the Community Site or Minority\u002FUnderserved Community Site in another National Cancer Institute (NCI) Community Oncology Research Program (NCORP) Cancer Care Delivery Research (CCDR) U34-supported protocol funded in NCI fiscal year 2025 or later. (Note: WF- 2301CD CONNECT is exempt from this policy, as it was funded prior to NCI fiscal year 2025.)\n* RADIATION ONCOLOGIST (NON-PATIENT): Planning to leave their position at this practice within the next 12 months\n* RADIATION ONCOLOGIST (NON-PATIENT): Providing service on a temporary basis (i.e., locum tenens providers)\n* RADIOLOGIST (NON-PATIENT): Planning to leave their position at this practice within the next 12 months\n* RADIOLOGIST (NON-PATIENT): Providing service on a temporary basis (i.e., locum tenens providers)\n* PATIENT: Unable to understand English or Spanish\n* PATIENT: Early glottic larynx cancer planned for definitive RT alone",{"count":357,"type":22},194,[164],"This clinical trial tests a new way to share radiation therapy plans using the Collaborative Oncology between Radiologists and Radiation oncologists for the Evaluation of Contoured Targets (CORRECT) workflow to improve communication and collaboration between radiation oncologists (ROs) and radiologists when determining cancer targets for radiation treatment. Systemic barriers limit critical communication between radiation oncologists and radiologists and can lead to both under and overdosing of radiation therapy (RT) tumor targets and failures to properly interpret post-treatment imaging. The limited formal diagnostic radiology training of many providers can make differentiating normal from disease imaging findings during target determination difficult, especially in complex disease sites like the lung, head, and neck. Inaccurate target determination may result in cancer return, excess toxicity, or both. Likewise, radiologists who cannot access prior RT plans may mistake expected RT changes for recurrent cancer or overlook true progression. The CORRECT workflow was developed by ROs and radiologists to address RO-radiology communication barriers by facilitating sharing of comprehensive RT target contours during RT planning. The CORRECT workflow begins with the normal process of RO target contouring. Computed tomography (CT) images are then fused with RT targets and pushed to a pre-designated Picture Archiving and Communications System (PACS) software folder accessible by the radiology department. The radiologist can then review the fused images at their chosen time and annotate images to indicate potential deviations (e.g., not avoiding normal tissue or not including all tumor). The RO reviews the annotated images and decides if any changes to treatment targets are needed for the final treatment plan. Through this independent, asynchronous review of high-quality images, CORRECT overcomes many of the limitations of existing communication methods between RO-radiologist, fostering a more collaborative, efficient, and precise approach to cancer treatment planning.",[143,35],"NOT_YET_RECRUITING","2026-03-20",{"date":364,"type":92},"2026-03-23",{"date":89,"type":22},{"date":367,"type":22},"2028-11-01",{"name":369,"class":99},"Wake Forest University Health Sciences",{"id":371,"slug":372,"hasResults":11,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":111,"phases":378,"briefSummary":379,"conditions":380,"keywords":384,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":128},"100479741","phase-1-dosing-study-of-radiation-combined-with-tislelizumab-and-pamiparib-in-patients-with-previously-treated-head-and-neck-cancer-100479741","NCT05526924","Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer","A Phase I Trial of Re-Irradiation With Concurrent Chemotherapy in Combination With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Clinically documented recurrent head and neck cancer requiring regional therapy.\n* Human papillomavirus (HPV) testing for oropharynx primary tumors by p16 immunohistochemistry (IHC) positivity\n* Availability of more than (or equal to) 10 unstained 5 micron slides (to be provided to Human Tissue Resource Center at the University of Chicago). Subjects who cannot fulfill this requirement will need to undergo a new biopsy prior to enrollment on study.\n* Recurrent or second primary, previously irradiated head and neck squamous cell carcinoma without clinically measurably distant metastatic disease, or low volume oligometastatic disease amenable to Stereotactic Body Radiation Therapy (SBRT) or other curative-intent therapy (e.g. surgery, radiation frequency ablation therapy)\n* Prior radiation therapy completed in 4 months (or longer) , and\u002For chemotherapy, immunotherapy, or targeted therapy completed 1 month (or earlier) before study entry, and patient should have recovered from any adverse effects.\n* Prior programmed death-1 (PD-1)\u002F programmed death ligand-1 (PD-L1) inhibition is permitted.\n* Prior chemotherapy is permitted.\n* Patients who undergo surgical salvage therapy with positive margin or extranodal extension or other high-risk patients determined during multidisciplinary tumor board who are eligible for adjuvant re-irradiation therapy are eligible.\n* 18 years of age and older.\n* Eastern Cooperative Oncology Group performance status of one or less.\n* Life expectancy of greater than 12 weeks.\n* Negative serum or urine pregnancy test at screening for patients of childbearing potential.\n* Patients must have normal organ and marrow functions as defined by lab values that will be confirmed by the study doctor.\n* Age, Sex, and Reproductive Status:\n\n  1. Women of childbearing potential (WOCBP=premenopausal woman capable of becoming pregnant) must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug.\n  2. Women must not be breastfeeding.\n  3. WOCBP must agree to follow instructions for highly effective method(s) of contraception for the duration of treatment and for 180 days (6 months) after the last dose of study drug(s).\n  4. Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 180 days (6 months) after the last dose of study drug(s).\n  5. Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. Females must still undergo pregnancy testing as described in this section.\n\nInvestigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of \\\u003C1% when used consistently and correctly.\n\n* At a minimum subjects must agree to the use of one method of highly effective contraception as listed in Appendix D. In addition, male subjects are expected to use a condom as noted in Appendix D. The effects of tislelizumab and pamiparib on the developing human fetus are unknown. For this reason and because monoclonal antibodies and PARP inhibitor agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of pamiparib and tislelizumab administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* • Previously untreated patients with locoregional-only disease are not eligible.\n\n  * Patients who have had chemotherapy within 4 weeks prior to entering the study, or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.\n  * Patients may not be receiving any other investigational agents.\n  * History of allergic reactions attributed to compounds of similar chemical composition or excipients used in the study.\n  * Any condition that required systemic treatment with either corticosteroids (\\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s).\n\n    * Note: Patients who are currently or have recently been on any of the following corticosteroid regimens are not excluded:\n* Adrenal replacement corticosteroid (dose ≤ 10 mg daily of prednisone or equivalent)\n* Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption\n* Short course (≤ 7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a nonautoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact allergen)\n\n  * Has hypersensitivity to tislelizumab, pamiparib, or any other drug used in this protocol.\n  * Has a known history of active tuberculosis (Bacillus Tuberculosis infection)\n  * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or any tumors that are not likely to influence live expectancy in the subsequent 3 years without active treatment (e.g. low grade prostate cancer in absence of therapy), or prior history of acute myeloid leukemia (AML)\u002Fmyelodysplastic syndrome (MDS).\n  * Has active autoimmune disease that has required systemic treatment in the past year (i.e. with use of steroids or immunosuppressive drugs). Replacement therapy e.g. levothyroxine, insulin, or physiologic corticosteroid doses for adrenal or pituitary insufficiency, etc. are not considered a form of systemic treatment.\n  * Has known history of, or any evidence of active interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, or acute lung diseases.\n  * Has a history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies).\n  * Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected). However, if eradicated subject is eligible.\n  * Has received a live vaccine within 28 days of planned start of study therapy.\n\n    o Note: Vaccines for COVID-19 are allowed except for any live vaccine that may be developed. Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed within 28 days prior to initiation of treatment. Vaccines should not be given during the chemo-radiation phase until marrow function has normalized as vaccines may not be efficacious during periods of marrow suppression.\n  * Uncontrolled intercurrent illness including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n  * Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.\n  * Patients receiving any medications or substances that are known to be strong CYP3A inducers (eg. avasimibe, carbamazepine, mitotane, phenobarbital, phenytoin, rifabutin, rifampin\u002F rifampicin) are ineligible. Patients receiving herbal remedies\u002Fmedicines such as St. John's Wort (Hypericum perforatum) are also ineligible. See Sections 5.5.2 and 5.5.3 for prohibited medications on study.\n\nBecause the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list such as http:\u002F\u002Fmedicine.iupui.edu\u002Fclinpharm\u002Fddis\u002Ftable.aspx; medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.\n\n* Pregnant women are excluded from this study because pamiparib is a PARP inhibitor and tislelizumab is a humanized, immunoglobulin G4 (IgG4)-variant monoclonal antibody agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pamiparib and tislelizumab, breastfeeding should be discontinued if the mother is treated with pamiparib and tislelizumab.\n* HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with pamiparib and tislelizumab. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.\n* Disease\u002Fprocedure significantly affecting gastrointestinal function, such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction, or gastrointestinal perforation or fistulae. Note: Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed (assuming no drug interaction potential).",{"count":184,"type":22},[113],"The purpose of this study is to evaluate the safety, tolerability and maximum tolerated dose of tislelizumab in combination with pamiparib plus chemoradiotherapy (chemotherapy and radiation) in individuals with recurrent head and neck cancer, which means that the person's cancer has come back after treatment.\n\nParticipation in the study should last for about 15 months while participants receive tislelizumab and chemoradiotherapy with pamiparib. Afterwards, they will return to the clinic for follow up every 4 months for 2 years, every 6 month for the next 2 years, and then once a year for the rest of their life.",[190,381,35,382,383],"Head and Neck Squamous Cell Carcinoma","Head and Neck Cancer Stage IV","Head and Neck Cancers - Throat",[385,386,381,387,388],"head and neck cancer","head and neck carcinoma","throat cancer","HNSCC treatment","2026-03-02",{"date":391,"type":92},"2026-03-04",{"date":393,"type":92},"2023-03-07",{"date":395,"type":22},"2028-01-01",{"name":397,"class":99},"University of Chicago",{"id":399,"slug":400,"hasResults":11,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":111,"phases":407,"briefSummary":408,"conditions":409,"keywords":411,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":425},"100481064","phase-2-a-study-of-decreasing-radiation-therapy-and-chemotherapy-in-people-with-head-and-neck-cancer-100481064","NCT05544136","A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer","A Pilot Study of Radiation De-Escalation for p16 Negative Oropharyngeal Cancer and p16-Negative or Positive Laryngeal and Hypopharyngeal Cancers","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of SCC of the head and neck (excluding nasopharynx, nasal cavity\u002Fparanasal sinus, oral cavity, salivary, thyroid, and cutaneous primary malignancies).\n\n  * Any unknown primary SCC of the head and neck with radiographically detectable gross nodes is allowed (core or excisional biopsy acceptable; if excisional biopsy is performed, there must be residual radiographically detectable nodal disease; FNA may be acceptable only with PI and\u002For co-PI approval)\n  * If the primary site is oropharynx or unknown primary, P16 IHC must be negative.\n  * If the primary site is hypopharynx or larynx, any P16 status is acceptable (positive, negative, or unknown). P16 IHC is strongly encouraged when possible.\n* Clinical stage T0-3 N1-2C M0 (AJCC 7th edition) without evidence of distant metastasis based on staging FDG PET\u002FCT.\n* 18 years of age or older.\n* Must not have received prior radiation therapy or chemotherapy for HNC.\n* Patients who have had their primary site tumor removed by surgery but still have residual grossly enlarged, radiographically detectable lymph nodes are eligible for this study.\n* Karnofsky Performance Status (KPS) ≥ 70.\n* CT or MRI of the Neck with and without contrast\n\n  o Note: A CT scan of the Neck and\u002For a PET\u002FCT performed for the purposes of radiation planning may serve as planning tools.\n* Adequate hematologic function within 30 days prior to registration, defined as follows:\n\n  * White Blood Count (WBC) ≥ 2,000 cells\u002FµL\n  * Absolute neutrophil count (ANC) ≥ 1,000 cells\u002Fmm3\n  * Platelets ≥ 100,000 cells\u002Fmm3\n  * Hemoglobin ≥ 8.0 g\u002FdL; Note: The use of transfusion or other interventions to achieve Hgb ≥ 8.0 g\u002FdL is acceptable\n* Adequate renal function within 30 days prior to registration, defined as follows:\n\n  * Serum creatinine \\\u003C 1.5 mg\u002FdL or creatinine clearance (CrCl) ≥ 50 mL\u002Fmin determined by 24-hour collection or estimated by Cockcroft-Gault formula: CrCl male = \\[(140 - age) x (weight in kg)\\] \u002F \\[(Serum Cr mg\u002FdL) x (72)\\] CrCl female = 0.85 x (CrCl male)\n  * Patients with serum creatinine \\> 1.5 mg\u002FdL can be eligible for carboplatin-based chemotherapy with approval of co-PI (Dr. Eric Sherman\n* Adequate hepatic function within 30 days prior to registration, defined as follows:\n\n  * Bilirubin \\\u003C 2 mg\u002FdL\n  * AST or ALT \\\u003C 3 x the upper limit of normal\n* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential.\n* The subject\u002Flegally authorized representative (LAR) must provide study-specific informed consent prior to study entry.\n\nExclusion Criteria:\n\n* All nasopharyngeal, nasal cavity\u002Fparanasal sinus, oral cavity, salivary gland, thyroid, and cutaneous primary malignancies.\n* Any T4 or N3 patients\n* Any prior radiotherapy to the head and neck region.\n* Any prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different non-H\\&N cancer is permissible.\n* Prior chemotherapy or radiotherapy within the last three years.\n* Patients who underwent previous surgical resection for the same disease (except for biopsy or surgery removing primary site tumor but still present with grossly enlarged, radiographically detectable lymph nodes).\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years estimated to be ≥ 90%.\n* Subjects with simultaneous primary cancers outside of the oropharynx\n\n  o Note: Exceptions can be made for patients with simultaneous primaries outside the H\\&N if determined by the PI\u002FCo-PI that the patient can proceed with protocol activities.\n* Pregnant (confirmed by serum b-HCG in women of reproductive age) or breastfeeding.\n* Severe, active co-morbidities defined as follows:\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 bacterial or fungal infection requiring intravenous antibiotics 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 defects.",{"count":406,"type":22},12,[114],"The purpose of this study is to test the treatment approach of de-escalated radiation and chemotherapy followed by a planned neck dissection surgery in people with head and neck cancer. The study will look at how effective the treatment approach is against participants' cancer.",[190,35,410,381],"Head and Neck Neoplasms",[412,190,381,413,414,415,416],"Unknown Primary Squamous Cell Carcinoma","fluoromisonidazole","18F-FMISO","Memorial Sloan Kettering Cancer Center","22-227","2026-02-25",{"date":419,"type":92},"2026-02-27",{"date":421,"type":92},"2022-09-12",{"date":423,"type":22},"2027-03-12",{"name":415,"class":99},6,{"id":427,"slug":428,"hasResults":11,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":432,"eligibilityCriteria":433,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":111,"phases":436,"briefSummary":437,"conditions":438,"keywords":439,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":128},"100538301","phase-2-heavy-strength-training-in-head-and-neck-cancer-survivors-100538301","NCT06289049","Heavy Strength Training in Head and Neck Cancer Survivors","Feasibility and Preliminary Efficacy of Heavy Lifting Strength Training Versus Usual Care in Head and Neck Cancer Survivors: A Randomized Controlled Trial","LIFTING2","Inclusion Criteria:\n\n* males and females, 18 years of age and older\n* any head and neck cancer subtype, stage, and treatment type\n* at least 1-year posttreatment with adequate shoulder range of motion (must meet minimum cutpoints for active flexion and abduction to be eligible)\n* no unmanaged medical conditions, alcohol, or drug abuse\n* approved for exercise by oncologist and a certified exercise physiologist or kinesiologist\n* ability to understand and communicate in English\n\nExclusion Criteria:\n\n* has met the Canadian Physical Activity strength training guidelines within the past one-month: at least two days per week of muscle and bone strength training activities using major muscle groups\n* currently involved in a different exercise trial or clinical drug trial",{"count":435,"type":22},60,[114],"Despite improvements in treatments, head and neck cancer survivors (HNCS) still endure acute and chronic side effects such as loss of muscular strength, limitations in physical functioning, fatigue, and swallowing difficulties that impact quality of life (QoL) and limit return to work. Light-to-moderate intensity strength training (LMST) has been shown to improve some side effects. Heavy lifting strength training (HLST) may further improve outcomes in some populations, however, only one small pilot study has focused on HNCS. The LIFTING 2 trial will be the first to examine the feasibility and effects of a HLST program versus no exercise in HNCS.",[410,190,381,35],[440,441,442,443],"Strength Training","Exercise","Quality of Life","Randomized Controlled Trial","2026-02-04",{"date":446,"type":92},"2026-02-09",{"date":448,"type":92},"2025-02-17",{"date":450,"type":22},"2026-06",{"name":452,"class":99},"University of Alberta",{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":457,"acronym":458,"eligibilityCriteria":459,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":111,"phases":462,"briefSummary":463,"conditions":464,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":128},"100560075","personalized-ultrafractionated-stereotactic-adaptive-radiotherapy-for-palliative-head-and-neck-cancer-treatment-puls-pal-100560075","NCT06572423","Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy for Palliative Head and Neck Cancer Treatment (PULS-Pal)","PULS-Pal","Inclusion Criteria:\n\n* \\>= 18 years old\n* Diagnosis of primary or recurrent, localized or metastatic (American Joint Committee on Cancer (AJCC) 8th Edition stages I-IV) head and neck cancer. In primary diagnosis cases, pathologic confirmation is required. In recurrent and\u002For metastatic diagnosis cases, pathologic confirmation is not required if not beneficial to the patient as standard of care, and diagnosis can be assumed based on clinical and\u002For radiographic evidence\n* Ineligible for or declines standard of care definitive treatment(s), which will be documented in the patient's trial screening progress note in their electronic medical record by the treating physician\n* Measurable disease within the head and\u002For neck clinically and\u002For on imaging studies (CT, PET, MRI) within 30 days from date of enrollment\n* Patient maximum tumor(s) or tumor bed diameter must be less than 10cm\n* In a woman of childbearing potential, a negative serum or urine pregnancy test within 1 week of treatment start must be documented. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study treatment\n* Patients with a tracheostomy and\u002For a percutaneous endoscopic gastrostomy tube are eligible for inclusion\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding\n* More than 1 prior radiation treatment course directed to the treatment area over the patient's lifetime. In patients who have received 1 prior radiation treatment course directed to the treatment area, that prior radiation treatment course must have concluded at least 6 months prior to trial enrollment\n* Any comorbidity or condition which would limit full compliance with the protocol",{"count":461,"type":22},43,[164],"This trial tests how well personalized ultra fractionated stereotactic adaptive radiotherapy (PULSAR) works together with HyperArc© radiation treatment planning technology for palliative (holistic pain and symptom control) tumor control in patients with primary or recurrent, localized or metastatic head and neck cancer (HNC) who are ineligible for or decline standard of care treatment. Researchers want to evaluate if using HyperArc and PULSAR together will deliver higher, possibly more effective doses, resulting in better tumor control with the same or fewer side effects than smaller routine doses. PULSAR is a radiation therapy regimen that uses a limited number of fairly large dose pulses while adjusting to specific anatomic and\u002For biological changes which may occur during the course of the treatment. HyperArc radiation treatment planning technology is a tool that allows for target dose escalation to tumor tissue while maintaining minimal head and neck organs-at-risk doses compared to other radiation treatment planning software. Undergoing PULSAR and HyperArc technology together may be a safe and effective palliative treatment option for patients with HNC.",[35,465,466,467],"Localized Head and Neck Carcinoma","Metastatic Head and Neck Carcinoma","Recurrent Head and Neck Carcinoma","2026-02-03",{"date":470,"type":92},"2026-02-05",{"date":472,"type":92},"2024-10-25",{"date":474,"type":22},"2029-12-16",{"name":476,"class":99},"Jonsson Comprehensive Cancer Center",{"id":478,"slug":479,"hasResults":11,"nctId":480,"briefTitle":481,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":111,"phases":484,"briefSummary":485,"conditions":486,"keywords":487,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":128},"100610454","tongue-out-radiation-therapy-tort-for-the-mitigation-of-radiotherapy-related-toxicities-in-patients-with-head-and-neck-cancer-100610454","NCT07227792","Tongue-out Radiation Therapy (TORT) for the Mitigation of Radiotherapy-related Toxicities in Patients With Head and Neck Cancer","Inclusion Criteria:\n\n1. Must have histologically or cytologically confirmed squamous cell carcinoma of the oropharynx, larynx, or hypopharynx (cT0-4, N0-3, M0-1).\n2. Patients with metastatic disease will be included if the following criteria are met:\n\n   * Definitive RT dose is planned for the primary site\n   * The number of metastatic lesions is ≤5\n   * All metastatic lesions are confined to a single organ (e.g., lung)\n3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2\n4. Female subjects of childbearing potential must not be pregnant or breastfeeding at screening.\n\n   * Female subjects are considered to be of childbearing potential unless one of the following criteria is met:\n\n     o Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes. Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.\n   * Female subjects of childbearing potential must utilize an appropriate method of birth control such as hormonal methods (oral, injectable, implant, skin patch, vaginal ring), intrauterine devices, barrier methods (consistent use of male\u002Ffemale condoms, diaphragms, cervical caps), surgical methods (vasectomy, tubal ligation), or true abstinence.\n5. Must be able to comfortably protrude tongue in the treatment position for at least 1 minute.\n6. Must have the ability to understand and the willingness to sign a written informed consent document.\n7. Must be willing to comply with all study procedures.\n8. Must be able to complete patient-reported outcome (PRO) questionnaires in English.\n\nExclusion Criteria:\n\n1. Patients with T1-T2 N0 glottic cancer (i.e., planned to undergo RT to the larynx only)\n2. Posterior pharyngeal wall primary tumor\n3. Widely metastatic disease\n4. Surgical resection of the primary tumor\n5. Induction chemotherapy or immunotherapy prior to planned radiotherapy\n6. Prior head and neck radiotherapy",{"count":110,"type":22},[164],"Our institution recently began incorporating a novel \"tongue-out\" radiation therapy (TORT) technique for patients with head and neck tumors at particular subsites (oropharynx, larynx, hypopharynx). Protruding the tongue, i.e. \"tongue-out\" position, induces anatomical changes that facilitate decreased radiation dose to the oral tongue and PCM. The long-term goal is to determine whether TORT results in reduced severity and faster recovery from acute treatment-related toxicities (particularly mucositis, dysphagia, and dysgeusia) and improved long-term swallowing function and taste compared to traditional \"tongue-in\" RT for patients with HNC.",[35],[488,489,490,491],"Tongue-out radiation therapy (TORT)","human papillomavirus (HPV)-related oropharyngeal cancer","Intensity modulated radiotherapy (IMRT)","volumetric modulated arc therapy (VMAT)","2025-12-15",{"date":494,"type":92},"2025-12-17",{"date":496,"type":92},"2025-11-23",{"date":498,"type":22},"2029-01-31",{"name":500,"class":99},"Yvonne Mowery",{"id":502,"slug":503,"hasResults":11,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":508,"enrollmentInfo":509,"targetDuration":4,"studyType":111,"phases":511,"briefSummary":512,"conditions":513,"keywords":536,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":567},"100328442","phase-1-vmd-928-monotherapy-and-in-combination-with-pembrolizumab-to-treat-trka-overexpression-driven-solid-tumors-or-lymphoma-100328442","NCT03556228","VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma","A Phase 1\u002F2 Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 as Monotherapy and in Combination With Pembrolizumab in Subjects With Solid Tumors or Lymphoma","Key Inclusion Criteria:\n\n#. Histologically or cytologically confirmed diagnosis of any type of solid tumor malignancy or lymphoma:\n\nPhase 1 Dose Escalation only: Subjects with\n\n(A) any advanced solid tumors of\n\n1. Head and Neck Cancers (\"HNC\") (of any types),\n2. Esophageal cancer,\n3. Lung cancers (of any types),\n4. Mesothelioma,\n5. Pancreatic cancers,\n\nOr,\n\n(B) any NTRK1 gene fusion positive (\"NTRK1+\") solid tumors or lymphomas, that is relapsed, refractory or intolerant (R\u002FR\u002FI) to standard of care (SOC) and for which there is no approved or curative therapy. Additionally, patients must not be candidates for or have exhausted regimens known to provide clinical benefit, including hematopoietic stem cell transplantation in lymphoma patients if they are deemed transplant eligible.\n\nPhase 2 Monotherapy and Combination with Pembrolizumab only:\n\nSubjects must have\n\n1. TrkA-driven HNC, Esophageal, Lung, Mesothelioma, Pancreatic cancers; or,\n2. any NTRK1+ solid tumors or lymphoma\\*, that is R\u002FR\u002FI to SOC.\n\nKey Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 or 1.\n* Able to swallow and retain oral medication.\n* Subjects must either have available archival tumor tissue samples, or consent to tumor tissue sampling prior to the first dose.\n* Adequate organ system function as defined as follows:\n\n  1. Absolute neutrophil count ≥1.5x10\\^9\u002FL\n  2. Hemoglobin ≥9g\u002FdL\n  3. Platelets ≥100x10\\^9\u002FL\n  4. PT\u002FINR, PTT ≤1.5xULN\n  5. Total bilirubin ≤1.5x ULN\n  6. AST, ALT ≤2.5xULN\n  7. Creatinine ≤1.2xULN for age, weight\n  8. Calculated creatinine clearance or 24h urine creatinine clearance ≥60mL\u002Fmin\n\nKey Exclusion Criteria:\n\n* Received chemotherapy having delayed toxicity within the last 14 days (six weeks for prior nitrosourea or mitomycin C).\n* Received anticancer therapy with radiation, immunotherapy, and a biologic, surgery and\u002For tumor embolization within the past 2 weeks.\n* Received an investigational anticancer drug within 14 days or 5 half-lives of the investigational agent, whichever is longer, prior to the first dose of VMD-928. Any exceptions to the above must be approved by the Sponsor Medical Monitor.\n* Unresolved toxicity from previous anticancer therapy \\> CTCAE Grade 1 (except alopecia or anemia) unless agreed to by both the Sponsor Medical Monitor and the Investigator.\n* Known active infections including HIV disease.\n* Currently pregnant, nursing, or planning to become pregnant during the course of the study.\n* QTcF interval ≥ 480 msec.\n* Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.\n* Acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks.\n* Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would compromise the patient's safety or interfere with assessment of the drug.\n* Psychological, familial, sociological, geographical, or other concurrent conditions that would interfere with safety evaluation, limit the patient's ability to follow the procedures in the protocol or otherwise jeopardize compliance with the protocol. Patients with uncontrolled major depression, bipolar disorder, or severe anxiety disorder are excluded.\n* Patient has had or is currently having other malignant tumors within 3 years.\n* Patients have multiple factors that affect their oral medication.\n* Patients have long-term unhealed wounds or fractures.\n* Patients have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.\n* Patients are taking the following drugs and can't stop them during the study:\n\n  * Tylenol or medicine containing acetaminophen (paracetamol).\n  * Antacids (e.g. TUMS, calcium carbonate, or magnesium hydroxide), proton pump inhibitors (e.g. omeprazole), H2 blockers (e.g. famotidine), or buffered vitamins.\n* Epstein-Barr virus (EBV) negative nasopharyngeal carcinoma.\n\nFor Phase 2 only:\n\n* Negative result on TrkA immunohistochemistry (IHC) assay.\n* Have visceral crisis, defined as severe organ dysfunction and rapid progression of the cancer. (It is not about presence of visceral metastasis.)\n\nFor combination therapy with Pembrolizumab only:\n\n* Serious adverse immune related adverse events (grade 3 or 4) with previous PD-1(L1) inhibitor therapy, that were symptomatic and required prolong immunosuppression (\\>6 weeks).\n* Any grade Pneumonitis and Myocarditis related to prior PD-1(L1) inhibitor therapy.\n* For subjects that received PD-1(L1) inhibitors before, there should be a washout period of at least 21 days between the last day of PD-1(L1) inhibitor and first day of study medications.\n* Subjects who relapsed after prior treatment with PD-1(L1) inhibitors. Relapsed is defined as patients having best overall response of CR or PR after treatment with a PD-1(L1) inhibitor.","80 Years",{"count":510,"type":22},242,[113,114],"This is a multicenter, open-label, Phase 1\u002F2 study of orally administered VMD-928 monotherapy and in combination with pembrolizumab in adult subjects with advanced solid tumors or lymphoma that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists",[35,514,515,516,517,518,519,520,381,521,522,523,524,383,525,526,527,528,529,530,531,532,533,534,535],"Adenoid Cystic Carcinoma","Lung Cancer","Non-Small Cell Lung Cancer","Pancreatic Cancer","Mesothelioma","Esophageal Cancer","Any Solid Tumors Progressed After a Prior Immunotherapy","Head and Neck Squamous Cell Carcinoma HNSCC","Salivary Gland Carcinomas","Head and Neck Cancers - Salivary Gland","Head and Neck Cancers - Nasopharyngeal","Small Cell Lung Cancer ( SCLC )","Lung Cancer (Locally Advanced or Metastatic)","Head and Neck Cancers - Tonsils","Head and Neck Cancers Hypopharynx","Head and Neck Cancers Larynx","Head and Neck Cancers Lip","Head and Neck Cancers Nasopharynx","Head and Neck Cancers Oral Cavity","Head and Neck Cancers","Head and Neck Cancers Oropharynx","Head and Neck Cancers Trachea",[537,538,35,514,515,516,539,518,540,541,542,543,544,545,546,533,547,548,549,550,551,552,553,554,555,556],"TrkA","NTRK1","NSCLC","Pancreatic","Progression after anti PD-1\u002FPD-L1 immunotherapy","Progressed after an immunotherapy","Esophageal","SCLC","ACC","HNSCC","HNC","Salivary Gland Carcinoma","Nasopharyngeal","Throat","Tonsils","Hypopharynx","Larynx","Oral Cavity","Oropharynx","Trachea","2025-12-04",{"date":559,"type":92},"2025-12-11",{"date":561,"type":92},"2018-06-08",{"date":563,"type":22},"2028-06",{"name":565,"class":566},"VM Oncology, LLC","INDUSTRY",15,{"id":569,"slug":570,"hasResults":11,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":111,"phases":578,"briefSummary":579,"conditions":580,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":128},"100516636","phase-1-therapeutic-vaccine-in-patients-with-human-papillomavirus-hpv-positive-oropharyngeal-cancer-100516636","NCT06007092","Therapeutic Vaccine in Patients With Human Papillomavirus HPV-positive Oropharyngeal Cancer","Multicentric Randomized Phase I\u002FIIa Trial of the Safety and Immunogenicity of a Therapeutic Anti-HPV DC Targeting Vaccine in Patients With Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer","HPVDCVax","Inclusion Criteria:\n\n1. Males and females ≥ 18 years of age.\n2. Willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.\n3. Subjects with histologically confirmed oropharyngeal squamous cell carcinoma.\n4. HPV16 genotyping determined by a specified central reference laboratory with an established polymerase chain reaction (PCR)- based assay on FFPE archived tumor biopsies (or 10 slices of 5µm).If local HPV16 genotype assessment has been performed, the subject can be enrolled if the result shows HPV16 positivity. Confirmation of HPV16 positive status will be performed retrospectively by the central laboratory on archived tissue. Formalin- fixed tumour biopsies or surgical piece before local radical treatment can be optionally available for translational research.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n6. Comprehensive curative treatment according to the disease stage and national guidelines, completed at least 16 weeks prior to study drug administration. The recommended duration between end of curative treatment and study drug administration is 18 to 20 weeks.\n7. No evidence of residual or recurrent disease on the last assessment, comprising a physical examination, a head and neck CT-scan or a head and neck MRI, and a thoracic CT Scan (and TEP-scan only for patients traited by radiotherapy or radiochemotherapy without surgery).\n8. Vaccination for Covid and Flu vaccines are authorised 4 weeks before or after the administration of poly-ICLC-adjuvanted CD40HVac (2 weeks during flu period for the Flu vaccine)\n9. Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to randomization:\n\n   i) White blood cell count (WBC) ≥ 2 x 109\u002FL ii) Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL iii) Platelets ≥ 100 x 109\u002FL iv) Hemoglobin ≥ 9.0 g\u002FdL v) Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) \\> 40 mL\u002Fmin (using the Cockcroft-Gault formula): Female CrCl = (140 - age in years) x weight in kg x 0.85\u002F 72 x serum creatinine in mg\u002FdL Male CrCl = (140 - age in years) x weight in kg x 1.00 \u002F 72 x serum creatinine in mg\u002FdL vi) Hepatic function: Total bilirubin ≤ 1.5 x ULN. Subjects with Gilbert's Disease and total bilirubin up to 3 x ULN may be eligible if total bilirubin\\\u003C 3.0 mg\u002FdL.Transaminases (ALT and AST) ≤ 3 x ULN, Alkaline phosphatase ≤ 2.5 x ULN\n10. Participants who were born female: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed before randomisation and on the day of initial IMP administration (W0)\n\n    • Reproductive status: if heterosexually active female, consistently using an effective method of contraception with partner for sexual activity that could lead to pregnancy from at least 21 days prior to enrolment through 4 months after the last administration.\n\n    Effective contraception is defined as using any of the following methods:\n    * Condoms (male or female) with or without a spermicide;\n    * Intrauterine device (IUD);\n    * Intrauterine hormone releasing system (IUS);\n    * Hormonal contraception (progesterone only);\n    * Successful vasectomy in the male partner (considered successful if a participant reports that a male partner has (i) documentation of azoospermia by microscopy, or (ii) a vasectomy more than 2 years ago with no resultant pregnancy despite unprotected sexual activity postvasectomy);\n    * Or not be of reproductive potential, such as having reached menopause (no menses for 1 year without an alternative medical cause) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation.\n    * Agree not to seek pregnancy including through alternative methods, such as artificial insemination or in vitro fertilization until 4 months after the last administration.\n\n    Participants who were born male, if heterosexually active male, using an effective method of contraception with their partner from the first day of IMP administration until 4 months after the last administration. This also applies to sperm donation.\n11. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed.\n12. Patients must be affiliated to a social security system or beneficiary of the same\n\nExclusion Criteria:\n\n1. Clinical evidence on physical or radiological examination of residual or recurrent HPV-driven carcinoma on the primary site, in neck lymph nodes, or in any distant site metastasis.\n2. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.\n3. Subjects with active, known, diagnosed or suspected auto-immune disease. Subjects suffering from vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring thyroid hormone replacement therapy, or psoriasis not requiring systemic treatment can be enrolled.\n4. Patients diagnosed with active interstitial lung disease (ILD)\u002Fpneumonitis or a history of ILD\u002Fpneumonitis within the last 5 years, or another condition requiring immunosuppressive doses of medication such as systemic corticosteroids or absorbed topical corticosteroids (doses ≥ 10 mg\u002Fday prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical corticosteroids and adrenal replacement doses \\\u003C 10 mg daily prednisone or equivalent are permitted.\n5. Subjects requiring maintenance treatment with immunosuppressive doses of systemic corticosteroids. Subjects being treated with a short course of corticosteroids (\\> 10 mg\u002Fday prednisone equivalents) should discontinue this therapy at least 2 weeks prior to start of study treatment.\n6. Prior treatment with therapeutic anti-HPV vaccines.\n7. Invasive surgery (defined as surgical intervention requiring general or spinal anesthesia, and hospital admission) within 28 days prior to start of study treatment.\n8. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus.\n9. Patient with active infection must be postponed until infection resolution\n10. Subjects with an uncontrolled or significant heart disease such as long QT syndrome with QTcF \\> 480 ms on baseline ECG, NYHA III\u002FIV or uncontrolled arrhythmia.\n11. History of organ transplantation, including allogenic peripheral stem cell or bone marrow transplantation.\n12. Participation in another clinical study with an investigational product during the last 6 months and while on study treatment\n13. Vaccination for Covid and Flu vaccines is not permitted within 4 weeks prior the first vaccination with polyICLC adjuvanted CD40HPVac (2 weeks during flu period for the Flu vaccine.\n14. Treatment is not permitted within 4 weeks prior the first vaccination and 4 months after the last injection. Furthermore, the use of this medication will be considered as a deviation to the protocol.\n\n    * curative treatment within 12 weeks before the first injection,\n    * Corticosteroids,\n    * Live attenuated vaccines (such as measles, mumps, and rubella \\[MMR\\]; oral polio vaccine \\[OPV\\]; varicella; yellow fever) or any vaccines that are not live attenuated (eg, tetanus, pneumococcal, Hepatitis A or B) except IMP vaccine.\n    * Immunosuppressive medications (Not excluded: \\[1\\] corticosteroid nasal spray; \\[2\\] inhaled corticosteroids; \\[3\\] topical corticosteroids for mild, uncomplicated dermatitis; or \\[4\\] a single course of oral\u002Fparenteral corticosteroids at doses \\\u003C 2 mg\u002Fkg\u002Fday and length of therapy \\\u003C 11 days with completion at least 30 days prior to enrollment)\n    * Blood products\n    * Immunoglobin\n    * Anti-tuberculosis drugs\n    * Immunomodulators (such as cytokines or interferons) or immunosuppressive drugs during 8 weeks preceding the screening visit and as of 4 months after the last injection will not be allowed. If any patient needs chronic use of one of these medicine during this period, the subject will be withdrawn from the investigational product but should be followed at all visits as planned by the protocol\n    * Antipyretic will not be allowed twelve (12) hours before immunization as preventive treatment of pain or fever.\n15. Pregnant or breastfeeding women or intending to become pregnant during study\n16. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent",{"count":577,"type":22},24,[113,114],"This study is a multicentric double-blind placebo-controlled dose escalation trial of a CD40HVac vaccine (humanized anti-CD40 mAb fused to HPV16 E6\u002FE7 oncoproteins) adjuvanted with poly-ICLC (Hiltonol) in patients with HPV16 oropharyngeal carcinoma with no evidence of residual or recurrent disease after surgery and\u002For radiochemotherapy.\n\nThe primary objective is to determine the recommended phase 2 dose (RP2D) of a poly-ICLC(Hiltonol)-adjuvanted CD40HVac vaccine according to the safety and the capacity to elicit immune responses of different doses Two dose levels of poly-ICLC-adjuvanted CD40.HVac will be explored\n\n* 1st dose level: CD40.HVac 1.0 mg, with 1.0 mg poly-ICLC\n* 2nd dose level: CD40.HVac 3.0 mg, with 1.0 mg poly-ICLC The safety data will be reviewed by an IDSMB that will give recommendations.",[35,581],"Adult Disease","2025-11-24",{"date":584,"type":92},"2025-12-01",{"date":586,"type":92},"2023-07-31",{"date":588,"type":22},"2026-08",{"name":590,"class":99},"Gustave Roussy, Cancer Campus, Grand Paris",{"id":592,"slug":593,"hasResults":11,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":4,"eligibilityCriteria":597,"healthyVolunteers":16,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":598,"targetDuration":4,"studyType":111,"phases":600,"briefSummary":601,"conditions":602,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":128},"100591850","virtual-reality-interventions-for-the-improvement-of-depression-anxiety-and-pain-in-patients-with-head-and-neck-cancer-and-caregivers-100591850","NCT06985784","Virtual Reality Interventions for the Improvement of Depression, Anxiety and Pain in Patients With Head and Neck Cancer and Caregivers","Enhancing Patient Well-Being: Feasibility of Virtual Reality in Head and Neck Cancer Patients to Improve Depressive Symptomatology, Anxiety and Pain","Inclusion Criteria:\n\n* PATIENTS: Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* PATIENTS: ≥ 18 years\n* PATIENTS: Self-reported normal or corrected to normal vision and hearing\n* PATIENTS: Ambulatory (permitted to use walking aids such as cane or crutch)\n* PATIENTS: Ability to read and understand English for questionnaires\n* PATIENTS: Scheduled to undergo C\u002FRT for their HNC\n* CAREGIVERS: Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* CAREGIVERS: ≥ 18 years\n* CAREGIVERS: Self-reported normal or corrected to normal vision and hearing\n* CAREGIVERS: Ability to read and understand English for questionnaires\n* CAREGIVERS: A care giver identified by the patient and defined as a person who knows the patient well and is involved in the patient's medical care\n\nExclusion Criteria:\n\n* PATIENTS: An employee who is under the direct\u002F indirect supervision of the principal investigator (PI)\u002F a co-investigator\u002F the study manager\n* PATIENTS: A direct study team member\n* PATIENTS: Inability to complete the surveys\n* PATIENTS: Serious mental illness\n* PATIENTS: Previous head and neck cancer treatment\n* PATIENTS: History of any psychiatric disease treatment with anti-depressants, substance abuse, post-traumatic stress disorder (PTSD), chronic pain (\\> 3 months)\n* PATIENTS: Cancer in or around the eyes or ears; visual, hearing or cognitive impairment\n* CAREGIVERS: An employee who is under the direct\u002F indirect supervision of the PI\u002F a co-investigator\u002F the study manager\n* CAREGIVERS: A direct study team member\n* CAREGIVERS: Inability to complete the surveys\n* CAREGIVERS: Serious mental illness\n* CAREGIVERS: History of any psychiatric disease treatment with anti-depressants, substance abuse, PTSD",{"count":599,"type":22},40,[164],"This clinical trial tests how well a three-dimensional (3D) mindfulness virtual reality (VR) versus (vs) two-dimensional (2D) non-immersive interventions works in improving depression, anxiety, pain, and\u002For stress in patients with head and neck cancer (HNC) undergoing radiation or chemoradiation (C\u002FRT), and their caregivers. HNC patients undergoing C\u002FRT can experience higher levels of depression, anxiety, distress and pain that negatively impact their quality of life. VR allows for a realistic experience and works as an effective distraction tool from the state of pain or anxiety without use of drugs and with minimal associated risk to patients. VR has been shown to help reduce symptoms of depression, anxiety and pain in non-cancer patients, however there is limited evidence of how well VR use works in cancer patients, especially in patients undergoing C\u002FRT for HNC. Caregivers of these patients also experience high levels of anxiety and distress. Using VR interventions may improve depression, anxiety, pain and\u002For stress in patients with HNC undergoing C\u002FRT and their caregivers.",[35],"2025-11-06",{"date":605,"type":92},"2025-11-10",{"date":607,"type":92},"2025-06-25",{"date":609,"type":22},"2027-11-09",{"name":611,"class":99},"City of Hope Medical Center",{"id":613,"slug":614,"hasResults":11,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":618,"eligibilityCriteria":619,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":620,"targetDuration":4,"studyType":111,"phases":622,"briefSummary":623,"conditions":624,"keywords":625,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":631,"startDateStruct":633,"completionDateStruct":635,"leadSponsor":637,"locationsCount":128},"100597409","phase-1-accelerator-based-bnct-boron-neutron-capture-therapy-for-head-and-neck-carcinoma-100597409","NCT07058116","Accelerator-based BNCT (Boron Neutron Capture Therapy) for Head and Neck Carcinoma.","Accelerator-based Boron Neutron Capture Therapy (BNCT) in the Treatment of Locally Recurrent Head and Neck Carcinoma: A Phase I Study.","BNCT","Inclusion Criteria:\n\n1. The patient considered for the study has provided a written informed consent as approved by the EC prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.\n2. ≥ 18 years of age at the time of enrollment.\n3. Histologically confirmed head and neck carcinoma.\n4. Inoperable cancer, prior surgery may or may not have been done.\n5. Prior radiotherapy or chemoradiotherapy has been given.\n6. Anticipated life expectancy of at least 6 months.\n\nExclusion Criteria:\n\nPatients who fulfill any of the following criteria will be excluded:\n\n1. Presence of distant metastases.\n2. World Health Organization (WHO) performance status \\> 2 (see Appendix 2).\n3. Concurrent uncontrolled localized cancer other than head and neck carcinoma or overtly metastatic cancer.\n4. The patient has access to a non-experimental, effective treatment option and is a suitable candidate for such therapy.\n5. Concomitant chemotherapy.\n6. Concurrent experimental therapy or participation in a trial with an experimental therapy within 3 months prior to study inclusion.\n7. Less than 3 months since prior radiation therapy.\n8. Major surgery within 4 weeks prior to study inclusion.\n9. Unremovable metal implants present in the head and neck region that will interfere with CT\u002FMRI-based dose-planning.\n10. Known sensitivity to the study drug.\n11. One or more of the following:\n\n    * Blood hemoglobin \\\u003C 100 g\u002FL, neutrophils \\\u003C 1.5 x 109\u002FL, platelet count \\\u003C 120 x 109\u002FL\n    * Serum\u002Fplasma creatinine \\> 1.5 x Upper Limit of Normal (ULN)\n    * Serum bilirubin 2.0 \\> ULN\n    * Serum ALT and\u002For AST \\> 2.0 x ULN\n    * Serum alkaline phosphatase \\> 2.5 x ULN\n12. Serious uncontrolled infection or other serious uncontrolled concomitant disease.\n13. Collagen vascular disease or a disease that is considered to increase radiosensitivity of normal tissues to radiation (e.g., ataxia-telangiectasia)\n14. The patient is unwilling or unable to comply with the CIP required follow-up visits for the duration of the study.\n15. Untreated or severe treated congestive heart failure, cardiac pacemaker, or renal failure.\n16. Restlessness or inability to lie in a cast for about 30 minutes.\n17. Clinical follow-up after therapy cannot be arranged or the patient is not willing to participate in the follow-up.\n18. Known pregnancy, breastfeeding, or planning of pregnancy; for women of childbearing potential, a negative urine pregnancy test must be obtained prior to enrollment.\n19. The patient is not able to understand the nature of the study and trial treatment options.\n20. Phenylketonuria.\n21. Fructose intolerance.",{"count":621,"type":22},10,[113],"This phase I study of an accelerator-based boron neutron capture therapy (BNCT) in the treatment of locally recurrent head and neck carcinoma, is sponsored by HUS, Haartmaninkatu 4, Helsinki, Finland and Neutron Therapeutics Finland OY, Kanavaranta 9 FIN-00290 Helsinki.\n\nThe indication is for patients with head and neck carcinoma that has recurred locally after conventional radiation therapy.\n\nThe primary objective is to demonstrate the safety of accelerator-based neutron radiation using the nuBeam Suite in delivering BNCT.\n\nThe secondary objective is the ability to deliver the planned radiation dose to the target site and the ability to plan the trial treatment using the trial treatment planning software, position and target the tumor site using the robotic table in conjunction with the CT scanner and calculate the required radiation dose for each planned BNCT trial treatment.\n\nTo establish these objectives, the following parameters will be controlled:\n\n* Objective response rate\n* Duration of response.\n* The clinical benefit rate (includes complete response, partial response, and stabilized disease for a minimum of 8 weeks since the date of the first BNCT).\n* Locoregional recurrence-free survival.\n* Progression-free survival.\n* Overall survival.\n* Quality of life.\n\nThe maximum sample size is 10 study subjects evaluable for safety.\n\nThe study does not involve randomization.\n\nRegarding the target population, the study subjects must fulfill each of the inclusion criteria:\n\n1. Patient has provided a written informed consent as approved by the EC prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.\n2. ≥ 18 years of age at the time of enrollment.\n3. Histologically confirmed head and neck carcinoma.\n4. Inoperable cancer, prior surgery may or may not have been done.\n5. Prior radiotherapy or chemoradiotherapy has been given.\n6. Anticipated life expectancy of at least 6 months\n\nPatients who fulfill any of the following criteria will be excluded:\n\n1. Presence of distant metastases.\n2. World Health Organization (WHO) performance status \\> 2\n3. Concurrent uncontrolled localized cancer other than head and neck carcinoma or overtly metastatic cancer.\n4. The patient has access to a non-experimental, effective treatment option and is a suitable candidate for such therapy.\n5. Concomitant chemotherapy.\n6. Concurrent experimental therapy or participation in a trial with an experimental therapy within 3 months prior to study inclusion.\n7. Less than 3 months since prior radiation therapy.\n8. Major surgery within 4 weeks prior to study inclusion.\n9. Unremovable metal implants present in the head and neck region that will interfere with CT\u002FMRI-based dose-planning.\n10. Known sensitivity to the study drug.\n11. One or more of the following:\n\n    * Blood hemoglobin \\\u003C 100 g\u002FL, neutrophils \\\u003C 1.5 x 109\u002FL, platelet count \\\u003C 120 x 109\u002FL\n    * Serum\u002Fplasma creatinine \\> 1.5 x Upper Limit of Normal (ULN)\n    * Serum bilirubin 2.0 \\> ULN\n    * Serum ALT and\u002For AST \\> 2.0 x ULN\n    * Serum alkaline phosphatase \\> 2.5 x ULN\n12. Serious uncontrolled infection or other serious uncontrolled concomitant disease.\n13. Collagen vascular disease or a disease that is considered to increase radiosensitivity of normal tissues to radiation (e.g., ataxia-telangiectasia)\n14. Patient is unwilling or unable to comply with the CIP required follow-up visits for the duration of the study.\n15. Untreated or severe treated congestive heart failure, cardiac pacemaker, or renal failure.\n16. Restlessness or inability to lie in a cast for about 30 minutes.\n17. Clinical follow-up after therapy cannot be arranged or the patient is not willing to participate in the follow-up.\n18. Known pregnancy, breastfeeding, or planning of pregnancy; for women of childbearing potential, a negative pregnancy test must be obtained prior to enrollment.\n19. The patient is not able to understand the nature of the study and trial treatment options.\n20. Phenylketonuria\n21. Fructose intolerance.\n\nThere is one investigational device included as part of this study. The nuBeam Suite has two main components, the Treatment Delivery System and the nuBeam Dose Engine.\n\nThe study drug included in this study is L-boronophenylalanine fructose (L-BPA Fructose)",[35],[626,618,627,35,628,629],"L-Boronophenylalanine","Boron Neutron Capture Therapy","Neutron Therapeutics","Helsinki University Hospital","2025-07-04",{"date":632,"type":92},"2025-07-10",{"date":634,"type":92},"2025-05-08",{"date":636,"type":22},"2026-01-30",{"name":638,"class":566},"Neutron Therapeutics, LLC",{"id":640,"slug":641,"hasResults":11,"nctId":642,"briefTitle":643,"officialTitle":644,"acronym":4,"eligibilityCriteria":645,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":646,"targetDuration":4,"studyType":111,"phases":648,"briefSummary":649,"conditions":650,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":651,"lastUpdatePostDateStruct":652,"startDateStruct":654,"completionDateStruct":656,"leadSponsor":658,"locationsCount":128},"100530168","evaluation-of-radiobiological-effects-in-skin-toxicities-head-and-neck-cancer-patients-with-pbs-proton-therapy-100530168","NCT06183268","Evaluation of Radiobiological Effects in Skin Toxicities Head and Neck Cancer Patients With PBS Proton Therapy","Evaluation of Radiobiological Effects in Skin Toxicities for Head and Neck Cancer Patients With Pencil Beam Scanning Proton Therapy","Inclusion Criteria:\n\n* The patient must consent to be in the study and must have signed an approved consent form conforming to federal and institutional guidelines.\n* Patients must be ≥ 18 years old.\n* Patient must have biopsy-proven squamous cell carcinoma, originating in the oral cavity, larynx, oropharynx, nasopharynx, or hypopharynx\n* Carcinoma of the neck of unknown primary site origin may be included if p16 positive\n* Clinical stage T1-2, N0-1, N2a-N3 or T3-4, any N (AJCC, 7th ed.), including no distant metastases\n* Patient can have prior surgical resection of a primary cancer in the head and neck at any previous time\n* Previous or concurrent chemotherapy is allowed\n* No serious health conditions as determined by physician that would impact ability to complete treatment or impact skin in the area of treatment\n\nExclusion Criteria:\n\n* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n* Head and neck radiotherapy that does NOT include at least one cervical lymph node level (I, II, III, IV, or V) in the target volume.\n* Children\n* Women who are pregnant.",{"count":647,"type":22},100,[164],"This purpose of this study is to examine skin reactions (called radiation dermatitis) that occur during pencil beam scanning (PBS) proton therapy. The researchers will test a unique technique called \"Spot Delete\" to see if it can reduce skin reactions for head \\& neck patients treated with PBS. The investigators will also use a special computer model to study how the energy of the proton beam (linear energy transfer) is related to these skin reactions. The study involves creating a treatment plan based on a CT scan, which helps guide the proton beam in the body.",[190,381,35],"2025-04-07",{"date":653,"type":92},"2025-04-08",{"date":655,"type":92},"2023-12-13",{"date":657,"type":22},"2030-01-02",{"name":659,"class":99},"Covenant Health Cancer Center",{"id":661,"slug":662,"hasResults":11,"nctId":663,"briefTitle":664,"officialTitle":664,"acronym":4,"eligibilityCriteria":665,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":666,"targetDuration":668,"studyType":23,"phases":4,"briefSummary":669,"conditions":670,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":671,"lastUpdatePostDateStruct":672,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":678,"locationsCount":319},"100535216","aiocc-italian-registry-on-head-and-neck-carcinomas-100535216","NCT06248944","AIOCC Italian Registry on Head and Neck Carcinomas","Inclusion Criteria:\n\n1. Adult patients (age ≥ 18 years old) diagnosed with carcinoma of the Head and Neck. The diagnosis should be done or verified by the expert site entering the information about the patient in the registry. Patients diagnosed with sarcomas and lymphomas are excluded.\n2. Patients entering the HCP at any clinical phase of the disease (diagnosis, treatment of primary cancer, treatment of recurrence, treatment of M+ etc.). The HCP will collect information on the entire disease regardless of when it started to manage the patient. The HCP can choose, based on its resources, for how many patients will be able to collect the data.\n3. New patients managed by the HCP from 2021 onwards + patients managed by the HCP, in active follow-up at the hospital\n\nExclusion Criteria:\n\n1\\. Patients whose medical records are unavailable for review",{"count":667,"type":22},7000,"5 Years","Multicentre, retrospective and prospective observational study aimed to set-up a clinical Italian registry in order to collect information on carcinoma of the Head and Neck.",[35],"2024-03-07",{"date":673,"type":92},"2024-03-08",{"date":675,"type":92},"2022-07-06",{"date":677,"type":22},"2027-07-06",{"name":679,"class":99},"Italian Head&Neck Society"]