Phase II Safety and Toxicity Study of Cisplatin With or Without Cetuximab and Concomitant Radiotherapy for Locoregionally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)
Conventional radiotherapy (65-70 Gy, 1.8 Gy per day) concurrently with weekly cisplatin
(40mg/m2) (group A, n=25) or with weekly cisplatin (40mg/m2) and weekly cetuximab 250mg/m2,
after initial dose of 400mg/m2) (group B, n=25) is applied (in a 1:1 randomization ratio).
Groups will be matched age, sex, PS, and disease site.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine safety and toxicity of combination
Toxicity is graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events version 1 system.
Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months
Charalambos Andreadis, MD
Theagenio Cancer Hospital
Greece: Ethics Committee