Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

20 Participants
are divided into 3 treatment groups
Group A: Arm I PD-L1 CPS 1-19 %Other 1 intervention
Group B: Arm II PD-L1 CPS 0Other 1 intervention
Group C: Arm III PD-L1 CPS > or = 20%Other 1 intervention

Trial outcomes

Primary outcomes

1

Treatment Completion

Number of participants who complete 4 cycles of systemic therapy followed by one week of radiation therapy within 14 weeks from start of therapy

Time frame
Approximately 14 weeks

Secondary outcomes

1

Assessment of the Overall Response Rate (ORR).

Number of participants who achieve a complete or partial response rate per RECIST criteria

Time frame
Approximately 12 weeks after completion of the treatment
2

Assessment of the Disease-Free Survival (DFS) and Overall Survival (OS).

Number of participants who have no evidence of disease and/or who are alive

Time frame
Approximately 3 years
3

Toxicity Assessment

Participants toxicity assessment (side effects) will be graded per the National Cancer Institute's (NCI) common terminology criteria for adverse events (CTCAE v5.0) reporting.

Time frame
Approximately 30 days post treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brown University

Lead sponsor

The Miriam Hospital

Collaborator

Rhode Island Hospital

Collaborator

Source ClinicalTrials.gov
Apply now