New hope for frail seniors with head and neck cancer: easier treatment regimen tested
NCT ID NCT06998069
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times
Summary
This study tests a milder combination of chemotherapy, immunotherapy, and radiation for adults aged 65 and older with head and neck cancer who are considered frail. The goal is to see if more patients can complete the full treatment course. The regimen is tailored based on a biomarker (PD-L1 CPS) and aims to control the disease while being easier to tolerate.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Carboplatin, Paclitaxel, Pembrolizumab, Cetuximab, and Radiation Therapy
- What this could lead to
- If successful, this could offer a gentler, effective treatment option for older adults with head and neck cancer who are too frail for standard therapy.
- What could go wrong
- This is a very small early-phase trial (20 participants) testing a reduced-intensity regimen. It may not work as well as standard treatment, and side effects from chemo, immunotherapy, and radiation are still possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Rhode Island and The Miriam Hospitals
RECRUITINGProvidence, Rhode Island, 02903/02906, United States
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