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.
See above summary.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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
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
Rhode Island and The Miriam Hospitals
Providence, Rhode Island, United States
RECRUITINGTreatment Completion
Number of participants who complete 4 cycles of systemic therapy followed by one week of radiation therapy within 14 weeks from start of therapy
Time frame: Approximately 14 weeks
Assessment of the Overall Response Rate (ORR).
Number of participants who achieve a complete or partial response rate per RECIST criteria
Time frame: Approximately 12 weeks after completion of the treatment
Assessment of the Disease-Free Survival (DFS) and Overall Survival (OS).
Number of participants who have no evidence of disease and/or who are alive
Time frame: Approximately 3 years
Toxicity Assessment
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.
Time frame: Approximately 30 days post treatment
Iole Ribizzi-Akhtar, MD
CONTACT
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Pembrolizumab, 200 mg, day 1 of each cycle, each cycle every 21 days for 4 cycles Radiation Therapy 30Gy 1 week