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Recruiting
NCT06998069
Head and Neck Cancer Study Project in the Geriatric Population
Conditions: Head and Neck Neoplasms
Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 20
Sponsor: Brown University
Location: Rhode Island and The Miriam Hospitals Providence Rhode Island
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 \
Source: ClinicalTrials.gov (NCT06998069). StuddyBuddy aggregates publicly available trial information.