Actively Recruiting
Head and Neck Cancer Study Project in the Geriatric Population
Led by Brown University · Updated on 2025-12-30
20
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
B
Brown University
Lead Sponsor
T
The Miriam Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Head and Neck Cancer Study Project in the Geriatric Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have pathology confirmed squamous cell carcinoma of the head and neck (unknown primary excluded)
- Disease stage confirmed between IB and IVA based on imaging
- Comprehensive geriatric assessment (CGA) score between 3 and 5
- Evaluation by medical oncology and radiation oncology
- Eligibility for systemic chemoimmunotherapy followed by radiation as determined by geriatric oncology team
- Age 65 years or older
- ECOG performance status 2 or less
- Adequate organ and marrow function with specified blood counts and liver enzymes
- Creatinine clearance 40 mL/min or higher (calculated by Cockcroft Gault)
- No severe autoimmune disease if receiving pembrolizumab
- HIV-infected patients on effective therapy with undetectable viral load within 6 months
- If chronic hepatitis B virus infection, viral load must be undetectable on suppressive therapy
- Hepatitis C virus infection must be treated and cured or have undetectable viral load if on treatment
- Patients with prior or concurrent malignancy that does not interfere with study safety or efficacy
- Cardiac function classified as New York Heart Association class 2B or better
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Previous systemic chemoimmunotherapy for head and neck cancer
- Presence of metastases, including treated brain metastases
- Uncontrolled intercurrent illness
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Trial Site Locations
Total: 1 location
1
Rhode Island and The Miriam Hospitals
Providence, Rhode Island, United States, 02903/02906
Actively Recruiting
Research Team
B
BrUOG
CONTACT
I
Iole Ribizzi-Akhtar, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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