Study on Head and Neck Cancer Treatment for Older Adults

Sponsor: Brown University

Sponsor score: 0

ClinicalTrials ID:NCT06998069

Provider View

This clinical trial is exploring a new treatment approach for older adults with certain stages of head and neck cancer. The study involves a detailed health assessment and a personalized treatment plan based on specific health markers.

Patient Parameters

Program Overview

This study focuses on patients aged 65 and older who have stage IB to IVA squamous cell carcinoma of the head and neck. Participants will undergo a comprehensive health assessment to determine their overall health status. Those identified as frail will receive a specially designed treatment plan that includes a combination of chemotherapy and/or immunotherapy, followed by radiation therapy. The treatment plan is tailored based on specific health markers related to the cancer.

Description

This study is designed for older adults with specific stages of head and neck cancer. Participants will first have a detailed health assessment to evaluate their overall health and frailty. Those who are considered frail will receive a new, less intense treatment plan. This plan includes four cycles of chemotherapy and/or immunotherapy, followed by radiation therapy. The treatment is personalized based on a specific marker related to the cancer, known as the PD-L1 CPS. The goal is to provide effective treatment while considering the unique health needs of older adults.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with squamous cell carcinoma of the head and neck (except unknown primary).
  • Cancer stage between IB and IVA, confirmed by imaging.
  • Frailty score of 3-5 from a comprehensive health assessment.
  • Evaluated by both medical and radiation oncology teams.
  • Eligible for chemotherapy and immunotherapy followed by radiation, as determined by the geriatric oncology team.
  • Aged 65 years or older.
  • General health status allowing for light work or better (ECOG score of 0-2).
  • Adequate blood and organ function, including:
    • Neutrophil count of at least 1.0 x 10^9/L
    • Platelet count over 100,000/mm3
    • Total bilirubin less than 1.5 times the normal limit
    • Liver enzymes (AST/ALT) less than 3 times the normal limit
    • Kidney function with creatinine clearance of at least 40 mL/min
  • No severe autoimmune diseases if receiving pembrolizumab.
  • HIV-positive patients must have an undetectable viral load on treatment.
  • Hepatitis B patients must have an undetectable viral load on treatment.
  • Hepatitis C patients must be treated and cured, or have an undetectable viral load if still on treatment.
  • No cancer spread to other parts of the body, including the brain.
  • No other cancers that could interfere with the study treatment.
  • Heart health must be stable, with a functional class of 2B or better.
  • Ability to understand and agree to the study requirements.

Exclusion Criteria

  • Previous treatment with chemotherapy and immunotherapy for head and neck cancer.
  • Uncontrolled ongoing illnesses.

Locations

FACILITYZIPCITYSTATE
Rhode Island and The Miriam Hospitals02903/02906ProvidenceRhode Island

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