Loading clinical trials...

RECRUITINGPHASE3

Head and Neck Cancer Study Project in the Geriatric Population

NCT06998069•Brown University

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.

Detailed Description

See above summary.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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:
•Absolute neutrophil count ≥1.0 x 109/L Platelets \>100,000/mm3 Total bilirubin \<1.5 x ULN Aspartate aminotransferase (ast/sgot) \<3 x ULN Alanine aminotransferase (alt/sgpt) \<3 x ULN Creatinine clearance ≥ 40 mL/min as determined by Cockcroft Gault (using actual body weight) or \<1.5 x Upper limit of normal
+7 more criteria

Exclusion Criteria

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

Locations (1)

Rhode Island and The Miriam Hospitals

Providence, Rhode Island, United States

Key Dates

Start Date

August 27, 2025

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2027

Last Updated

December 30, 2025

Enrollment

ESTIMATED participants

Conditions

Head and Neck Neoplasms

Interventions

Arm I Carboplatin, Paclitaxel, Pembrolizumab

DRUG

Arm II Carboplatin, Paclitaxel, Cetuximab

DRUG

Arm III Pembrolizumab

DRUG

Contacts

BrUOG

CONTACT

401-863-3000 BrUOG@brown.edu

Iole Ribizzi-Akhtar, MD

CONTACT

Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC

NCT06912087

Head and Neck NeoplasmsCarcinoma, Squamous Cell+4 more

View study

RECRUITING

NIDCD Otolaryngology Clinical Protocol Biospecimen Bank

NCT06303180

Hearing LossHead and Neck Neoplasms+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Head and Neck Cancer Study Project in the Geriatric Population

Inclusion Criteria

Exclusion Criteria

Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC

NIDCD Otolaryngology Clinical Protocol Biospecimen Bank

Exercise Prehabilitation in Patients With Head and Neck Squamous-cell Carcinoma: The FIT4TREAT Trial

The Effects on Auditory Function of RADiotherapy and Chemotherapy Treatments for Head and Neck Tumours (EARAD)

A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2

Safety and Tolerability of the Use of Copaiba in Patients With Oral Cancer Submitted to Radiotherapy