RecruitingPhase 3NCT06998069

Head and Neck Cancer Study Project in the Geriatric Population


Sponsor

Brown University

Enrollment

20 participants

Start Date

Aug 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a modified treatment approach for older adults (65+) with head and neck cancer, combining immunotherapy (pembrolizumab) with standard chemoradiation therapy, guided by a comprehensive geriatric assessment to ensure the treatment is appropriate for each patient's overall health. **You may be eligible if...** - You are 65 or older with confirmed squamous cell carcinoma of the head and neck - Your cancer is Stage IB–IVA (locally advanced, not yet metastatic) - Your geriatric assessment score (CGA) falls in the 3–5 range - Your organ function and blood counts are adequate - You have been evaluated by both medical oncology and radiation oncology **You may NOT be eligible if...** - You have already received systemic chemoimmunotherapy for head and neck cancer - You have metastatic disease (cancer spread to other organs including the brain) - You have uncontrolled intercurrent illness - You have a history of severe autoimmune disease that would prevent immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGArm I Carboplatin, Paclitaxel, Pembrolizumab

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

DRUGArm II Carboplatin, Paclitaxel, Cetuximab

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

DRUGArm III Pembrolizumab

Pembrolizumab, 200 mg, day 1 of each cycle, each cycle every 21 days for 4 cycles Radiation Therapy 30Gy 1 week


Locations(1)

Rhode Island and The Miriam Hospitals

Providence, Rhode Island, United States

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NCT06998069


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