drugset / Trial / NCT06998069
Head and Neck Cancer Study Project in the Geriatric Population
Phase 3
Recruiting
20 enrolled
Brown University
Rhode Island Hospital · collabThe Miriam Hospital · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-08-27
- Primary completion
- 2026-06-01
- Completion
- 2027-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 5 unknown | — |
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 175 mg/m2 | — |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | — |