Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-02 @ 1:40 AM
Study NCT ID:
NCT06998069
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-18
First Post:
2025-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Head and Neck Cancer Study Project in the Geriatric Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D000068818', 'term': 'Cetuximab'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2025-05-07', 'studyFirstSubmitQcDate': '2025-05-28', 'lastUpdatePostDateStruct': {'date': '2025-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Completion', 'timeFrame': 'Approximately 14 weeks', 'description': 'Number of participants who complete 4 cycles of systemic therapy followed by one week of radiation therapy within 14 weeks from start of therapy'}], 'secondaryOutcomes': [{'measure': 'Assessment of the Overall Response Rate (ORR).', 'timeFrame': 'Approximately 12 weeks after completion of the treatment', 'description': 'Number of participants who achieve a complete or partial response rate per RECIST criteria'}, {'measure': 'Assessment of the Disease-Free Survival (DFS) and Overall Survival (OS).', 'timeFrame': 'Approximately 3 years', 'description': 'Number of participants who have no evidence of disease and/or who are alive'}, {'measure': 'Toxicity Assessment', 'timeFrame': 'Approximately 30 days post treatment', 'description': "Participants toxicity assessment (side effects) will be graded per the National Cancer Institute's (NCI) common terminology criteria for adverse events (CTCAE v5.0) reporting."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Squamous cell carcinoma of the head and neck', 'Geriatric population'], 'conditions': ['Head and Neck Neoplasms']}, 'descriptionModule': {'briefSummary': 'This is a study conducted in patients with a diagnosis of stage IB-IVA squamous cell carcinoma of the head and neck. Patients will have a comprehensive geriatric assessment (CGA) as part of standard assessments. The patients classified as frail, with a CGA score of 3-5, will then be treated with a novel reduced intensity regimen. The regimen will be tailored based on the programmed cell death ligand 1 combined positive score (PD-L1 CPS) and will involve 4 cycles of systemic chemotherapy and/or immunotherapy followed by radiation treatment.', 'detailedDescription': 'See above summary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have the following\n* Pathology confirmed squamous cell carcinoma of the head and neck (unknown primary is excluded).\n* Confirmed stage of disease between IB and IVA, based on imaging studies.\n* CGA score of 3-5\n* Evaluation by medical oncology and radiation oncology.\n* Patients in the experimental group must be eligible for systemic treatment with chemoimmunotherapy followed by radiation treatment as determined by the geriatric oncology team.\n* Age ≥ 65 years.\n* ECOG performance status ≤ 2\n* Adequate organ and marrow function as defined below:\n\nAbsolute neutrophil count ≥1.0 x 109/L Platelets \\>100,000/mm3 Total bilirubin \\<1.5 x ULN Aspartate aminotransferase (ast/sgot) \\<3 x ULN Alanine aminotransferase (alt/sgpt) \\<3 x ULN Creatinine clearance ≥ 40 mL/min as determined by Cockcroft Gault (using actual body weight) or \\<1.5 x Upper limit of normal\n\nMales:\n\nCLcr (mL/min) = "\\[140 - age (years)\\] × weight (kg)" /"72 × serum creatinine (mg/dL)"\n\nFemales:\n\n(CLcr (mL/min) = "\\[140 - age (years)\\] × weight (kg)" /"72 × serum creatinine (mg/dL)" × 0.85\n\n* Patients receiving pembrolizumab must meet standard institutional criteria for immunotherapy including no history of severe autoimmune disease.\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patients with metastases, including treated brain metastases, are not eligible for enrollment.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients who have previously received systemic chemoimmunotherapy for H/N cancer.\n* Patients with uncontrolled intercurrent illness.'}, 'identificationModule': {'nctId': 'NCT06998069', 'briefTitle': 'Head and Neck Cancer Study Project in the Geriatric Population', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'Head and Neck Cancer Study Project in the Geriatric Population', 'orgStudyIdInfo': {'id': 'BrUOG 435'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm I PD-L1 CPS 1-19 %', 'interventionNames': ['Drug: Arm I Carboplatin, Paclitaxel, Pembrolizumab']}, {'type': 'OTHER', 'label': 'Arm II PD-L1 CPS 0', 'interventionNames': ['Drug: Arm II Carboplatin, Paclitaxel, Cetuximab']}, {'type': 'OTHER', 'label': 'Arm III PD-L1 CPS > or = 20%', 'interventionNames': ['Drug: Arm III Pembrolizumab']}], 'interventions': [{'name': 'Arm I Carboplatin, Paclitaxel, Pembrolizumab', 'type': 'DRUG', 'otherNames': ['Radiation Therapy'], 'description': 'Carboplatin, AUC 5, day 1 of each cycle, each cycle every 21 days for 4 cycles Paclitaxel, 175 mg/m2, day 1 of each cycle, each cycle every 21 days for 4 cycles Pembrolizumab, 200 mg, day 1 of each cycle, each cycle every 21 days for 4 cycles Radiation Therapy 30Gy 1 week', 'armGroupLabels': ['Arm I PD-L1 CPS 1-19 %']}, {'name': 'Arm II Carboplatin, Paclitaxel, Cetuximab', 'type': 'DRUG', 'otherNames': ['Radiation Therapy'], 'description': 'Carboplatin, AUC 5, day 1 of each cycle, each cycle every 21 days for 4 cycles Paclitaxel, 175 mg/m2, day 1 of each cycle, each cycle every 21 days for 4 cycles Cetuximab 400 mg/m2, day 1 of the first cycle and then 250 mg/m2 days 1, 8, 15 every 21 days for 4 cycles Radiation Therapy 30Gy 1 week', 'armGroupLabels': ['Arm II PD-L1 CPS 0']}, {'name': 'Arm III Pembrolizumab', 'type': 'DRUG', 'otherNames': ['Radiation Therapy'], 'description': 'Pembrolizumab, 200 mg, day 1 of each cycle, each cycle every 21 days for 4 cycles Radiation Therapy 30Gy 1 week', 'armGroupLabels': ['Arm III PD-L1 CPS > or = 20%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903/02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'contacts': [{'name': 'BrUOG', 'role': 'CONTACT', 'email': 'BrUOG@brown.edu', 'phone': '401-863-3000'}, {'name': 'Iole Ribizzi-Akhtar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rhode Island and The Miriam Hospitals', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'centralContacts': [{'name': 'BrUOG', 'role': 'CONTACT', 'email': 'BrUOG@brown.edu', 'phone': '401-863-3000'}, {'name': 'Iole Ribizzi-Akhtar, MD', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Miriam Hospital', 'class': 'OTHER'}, {'name': 'Rhode Island Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}