Head and Neck Neoplasms
Conditions
Keywords
Squamous cell carcinoma of the head and neck, Geriatric population
Brief 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.
Detailed description
See above summary.
Interventions
DRUGArm I Carboplatin, Paclitaxel, Pembrolizumab
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
DRUGArm II Carboplatin, Paclitaxel, Cetuximab
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
DRUGArm III Pembrolizumab
Pembrolizumab, 200 mg, day 1 of each cycle, each cycle every 21 days for 4 cycles Radiation Therapy 30Gy 1 week
Sponsors
Brown University
The Miriam Hospital
Rhode Island Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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 \<1.5 x ULN Aspartate aminotransferase (ast/sgot) \<3 x ULN Alanine aminotransferase (alt/sgpt) \<3 x ULN Creatinine clearance ≥ 40 mL/min as determined by Cockcroft Gault (using actual body weight) or \<1.5 x Upper limit of normal Males: CLcr (mL/min) = "\[140 - age (years)\] × weight (kg)" /"72 × serum creatinine (mg/dL)" Females: (CLcr (mL/min) = "\[140 - age (years)\] × weight (kg)" /"72 × serum creatinine (mg/dL)" × 0.85 * Patients receiving pembrolizumab must meet standard institutional criteria for immunotherapy including no history of severe autoimmune disease. * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * Patients with metastases, including treated brain metastases, are not eligible for enrollment. * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. * Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* Patients who have previously received systemic chemoimmunotherapy for H/N cancer. * Patients with uncontrolled intercurrent illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Completion | Approximately 14 weeks | Number of participants who complete 4 cycles of systemic therapy followed by one week of radiation therapy within 14 weeks from start of therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the Overall Response Rate (ORR). | Approximately 12 weeks after completion of the treatment | Number of participants who achieve a complete or partial response rate per RECIST criteria |
| Assessment of the Disease-Free Survival (DFS) and Overall Survival (OS). | Approximately 3 years | Number of participants who have no evidence of disease and/or who are alive |
| Toxicity Assessment | Approximately 30 days post treatment | 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. |
Countries
United States
Contacts
CONTACTBrUOG
CONTACTIole Ribizzi-Akhtar, MD
Outcome results
None listed