Randomized Phase II/III Trial of Radiation with Cisplatin at 100 mg/m2 Every Three Weeks versus Radiation with Weekly Cisplatin at 40 mg/m2 for Patients with Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Principal Investigator
Paul Harari, MD
Status
Temporarily Closed to Accrual
Date Opened To Accrual
October 27 2021
Disease Site
Head and Neck [HN]
Head and Neck
Phase
II/III
Developmental Therapeutics
No
Primary Objective
Phase II: To determine whether radiation with low-dose cisplatin weekly is superior in terms of acute toxicity, as measured by the T-scores (TAME method), to radiation with high-dose cisplatin every 3 weeks for patients with locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN).
Phase III:
- To determine whether radiation with low-dose cisplatin weekly is non-inferior to radiation with high-dose cisplatin every 3 weeks in terms of overall survival (OS) for patients with locoregionally advanced SCCHN.
- To determine whether radiation with low-dose cisplatin weekly is superior in terms of acute toxicity, as measured by the T-scores (TAME method), to radiation with high-dose cisplatin every 3 weeks for patients with locoregionally advanced SCCHN.
Patient Population
Pathologically (histologically or cytologically) proven diagnosis of SCCHN of the oropharynx, larynx, hypopharynx, orp16-positive unknown primary.
Target Accrual
1250