Head and Neck Cancer Study Project in the Geriatric Population

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Brown University
Study ID
NCT06998069
Phase
PHASE3
Status
Recruiting
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Conditions

  • Head and Neck Neoplasms

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Arm I Carboplatin, Paclitaxel, Pembrolizumab — DRUG
    Carboplatin, AUC 5, day 1 of each cycle, each cycle every 21 days for 4 cycles Paclitaxel, 175 mg/m2, day 1 of each cycle, each cycle every 21 days for 4 cycles Pembrolizumab, 200 mg, day 1 of each cycle, each cycle every 21 days for 4 cycles Radiation Therapy 30Gy 1 week
  • Arm II Carboplatin, Paclitaxel, Cetuximab — DRUG
    Carboplatin, AUC 5, day 1 of each cycle, each cycle every 21 days for 4 cycles Paclitaxel, 175 mg/m2, day 1 of each cycle, each cycle every 21 days for 4 cycles Cetuximab 400 mg/m2, day 1 of the first cycle and then 250 mg/m2 days 1, 8, 15 every 21 days for 4 cycles Radiation Therapy 30Gy 1 week
  • Arm III Pembrolizumab — DRUG
    Pembrolizumab, 200 mg, day 1 of each cycle, each cycle every 21 days for 4 cycles Radiation Therapy 30Gy 1 week

Study Details

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.

Key Dates

Start date
Aug 27, 2025
Status verified
Dec 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Arm I PD-L1 CPS 1-19 %
  • Other: Arm II PD-L1 CPS 0
  • Other: Arm III PD-L1 CPS > or = 20%

Primary Outcome Measure

Treatment Completion [ Time Frame: Approximately 14 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rhode Island and The Miriam HospitalsProvidenceRhode Island02903/02906
BrUOG
[email protected]
401-863-3000
Iole Ribizzi-Akhtar, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Rhode Island and The Miriam Hospitals· Providence, RI

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