Head and Neck Cancer Study for Older Adults

This study is for older adults (age 65 and up) with squamous cell carcinoma of the head and neck (a type of cancer). It's testing different treatment plans that include Carboplatin, Paclitaxel, Pembrolizumab (an immunotherapy drug), Cetuximab, and radiation therapy. The specific treatment you receive will depend on a test called PD-L1 (Programmed Death-Ligand 1) and a comprehensive geriatric assessment (CGA) score, which helps determine your overall health. The main goal is to see how many people complete their treatment, which is measured at about 14 weeks. The study is currently recruiting 20 participants.

Study design
This is an interventional study with 20 participants, testing different combinations of drugs and radiation. It is not specified if it is randomized or blinded.
What's involved
Participants will receive 4 cycles of systemic chemotherapy and/or immunotherapy, followed by radiation treatment. Each cycle is every 21 days.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures treatment completion at approximately 14 weeks. Further follow-up is not specified.

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NCT06998069

Head and Neck Cancer Study Project in the Geriatric Population

Recruiting
PHASE3Ages 65+InterventionalTreatment
Brown University
~20 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Arm I Carboplatin, Paclitaxel, PembrolizumabArm II Carboplatin, Paclitaxel, CetuximabArm III Pembrolizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment Completion
Measured over Approximately 14 weeks
Head and Neck Neoplasms
1 sites across 1 states
Rhode Island1

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Eligibility criteria

Inclusion

Patients must have the following
Pathology confirmed squamous cell carcinoma of the head and neck (unknown primary is excluded).
Confirmed stage of disease between IB and IVA, based on imaging studies.
CGA score of 3-5
Evaluation by medical oncology and radiation oncology.
Patients in the experimental group must be eligible for systemic treatment with chemoimmunotherapy followed by radiation treatment as determined by the geriatric oncology team.
Age ≥ 65 years.
ECOG performance status ≤ 2
Adequate organ and marrow function as defined below:
Patients receiving pembrolizumab must meet standard institutional criteria for immunotherapy including no history of severe autoimmune disease.
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
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.
Patients with metastases, including treated brain metastases, are not eligible for enrollment.
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.
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.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion

Patients who have previously received systemic chemoimmunotherapy for H/N cancer.
Patients with uncontrolled intercurrent illness.
  • Treatment CompletionApproximately 14 weeks

    Number of participants who complete 4 cycles of systemic therapy followed by one week of radiation therapy within 14 weeks from start of therapy