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.
Interventional
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
Yes
Charalambos Andreadis, MD
Principal Investigator
Theagenio Cancer Hospital
Greece: Ethics Committee
EEEK2008RCT2
NCT01301248
March 2008
June 2011
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