Head and Neck Cancer Clinical Trial
Official title:
A PHASE III RANDOMIZED STUDY ON POSTOPERATIVE RADIO- AND CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED HEAD AND NECK CARCINOMAS
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in
chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
die. It is not yet known if radiation therapy plus chemotherapy is more effective than
radiation therapy alone in treating patients with head and neck cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of high-dose radiation
therapy alone with high-dose radiation therapy plus cisplatin in treating patients with head
and neck cancer who have undergone surgery to remove the cancer.
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
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