Tailored reduced-intensity treatment for older adults with head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Patients aged 65 and older with stage IB–IVA squamous cell carcinoma undergo a comprehensive geriatric assessment (CGA) and those classified as frail (CGA score 3–5) are offered a reduced-intensity regimen. Treatment is tailored by PD-L1 combined positive score (CPS) and consists of four cycles of systemic therapy (chemo and/or immunotherapy) followed by radiation. Three experimental arms include carboplatin+paclitaxel+pembrolizumab, carboplatin+paclitaxel+cetuximab, or pembrolizumab alone depending on PD-L1 and treatment assignment. The trial is a Phase 3, interventional effort run at Brown-affiliated hospitals to determine whether these regimens can provide effective cancer control with better tolerability in a geriatric frail population.

Why it matters

Who can join: the full rules

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

Males:

CLcr (mL/min) = "\[140 - age (years)\] × weight (kg)" /"72 × serum creatinine (mg/dL)"

Females:

(CLcr (mL/min) = "\[140 - age (years)\] × weight (kg)" /"72 × serum creatinine (mg/dL)" × 0.85

* 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 Criteria:

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

Where it's running

• Rhode Island and The Miriam Hospitals
  Providence, Rhode Island, United States Recruiting

Study contacts

• Study coordinator: BrUOG
• Email: BrUOG@brown.edu
• Phone: 401-863-3000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.