A PHASE III RANDOMIZED STUDY ON POSTOPERATIVE RADIO- AND CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED HEAD AND NECK CARCINOMAS
OBJECTIVES: I. Determine whether the addition of cisplatin to high-dose postoperative
radiotherapy increases the disease-free survival rate of patients with locally advanced head
and neck carcinomas at high risk of recurrence following radical surgery.
OUTLINE: Randomized study. Patients are registered and randomized to treatment within 25
days of surgery. Arm I: Radiotherapy. Irradiation of the preoperative primary tumor site
with a boost to areas at high risk for recurrence using Co60 equipment, 4-6 MV linear
accelerators, or 6-12 MeV electrons. Arm II: Radiotherapy plus Single-Agent Chemotherapy.
Irradiation as in Arm I; plus Cisplatin, CDDP, NSC-119875.
PROJECTED ACCRUAL: A total of 338 evaluable patients will be studied.
Allocation: Randomized, Primary Purpose: Treatment
Jacques Bernier, MD, PhD
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
United States: Federal Government