Head and Neck Cancer Study Project in the Geriatric Population
Sponsor: Brown University • ClinicalTrials.gov ID: NCT06998069
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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.
Interventions
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Arm I Carboplatin, Paclitaxel, Pembrolizumab
(Drug)
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
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Arm II Carboplatin, Paclitaxel, Cetuximab
(Drug)
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
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Arm III Pembrolizumab
(Drug)
Pembrolizumab, 200 mg, day 1 of each cycle, each cycle every 21 days for 4 cycles Radiation Therapy 30Gy 1 week
Eligibility criteria
Conditions
Locations
- Rhode Island and The Miriam Hospitals — Providence, Rhode Island, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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