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New treatment option for Head and Neck Neoplasms
Official title Head and Neck Cancer Study Project in the Geriatric Population
ClinicalTrials.gov ID: NCT06998069
What this study is testing
What is Arm I Carboplatin, Paclitaxel, Pembrolizumab?
Arm I Carboplatin, Paclitaxel, Pembrolizumab is an investigational medicine, being studied as a potential treatment for head and neck neoplasms.
Also referred to as Radiation Therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- 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.
You likely can't join if
- Patients who have previously received systemic chemoimmunotherapy for H/N cancer.
- Patients with uncontrolled intercurrent illness.
See the full eligibility 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...
- 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...
- 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 how well it works assessment of the investigational regimen are eligible for...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Providence, Rhode Island, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Providence, Rhode Island, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.