NCT06998069 Head and Neck Cancer Study Project in the Geriatric Population
| NCT ID | NCT06998069 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Brown University |
| Condition | Head and Neck Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-08-27 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 20 participants in total. It began in 2025-08-27 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06998069 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Head and Neck Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06998069 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 20 participants.
Is NCT06998069 currently recruiting?
Yes, NCT06998069 is actively recruiting participants. Contact the research team at BrUOG@brown.edu for enrollment information.
Where is the NCT06998069 trial being conducted?
This trial is being conducted at Providence, United States.
Who is sponsoring the NCT06998069 clinical trial?
NCT06998069 is sponsored by Brown University. The trial plans to enroll 20 participants.