Head and Neck Cancer Study Project in the Geriatric Population
ConditionHead and Neck Neoplasms
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age65+
SponsorBrown University
About this trial
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
Qualifiers
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
Disqualifiers
Patients who have previously received systemic chemoimmunotherapy for H/N cancer.
Patients with uncontrolled intercurrent illness.
Trial design
Treatments tested in this trial
- Arm I Carboplatin, Paclitaxel, Pembrolizumab
- Arm II Carboplatin, Paclitaxel, Cetuximab
- Arm III Pembrolizumab
Treatment groups
20 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov