Head and Neck Cancer Clinical Trial
Official title:
Phase III Intergroup Trial of Surgery Followed by (1) Radiotherapy vs. (2) Radiochemotherapy For Resectable High Risk Squamous Cell Carcinoma of the Head and Neck
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 whether radiation therapy plus cisplatin 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 radiation therapy plus
cisplatin with radiation therapy alone in treating patients with head and neck cancer that
has been removed during surgery.
OBJECTIVES: I. Evaluate locoregional control rates, patterns of first failure, and overall
and disease-free survival in patients with advanced squamous cell carcinoma of the head and
neck at high risk of locoregional recurrence who are treated postoperatively with concurrent
cisplatin and radiotherapy. II. Compare the toxicity of concurrent chemoradiotherapy vs.
radiotherapy alone in the postoperative setting.
OUTLINE: Randomized study. Arm I: Radiotherapy. Involved-field irradiation using Co60, 1-6
MV photons, or electrons. Arm II: Radiotherapy plus Single-Agent Chemotherapy. Irradiation
as in Arm I; plus Cisplatin, CDDP, NSC-119875.
PROJECTED ACCRUAL: 438 patients will be entered over approximately 5 years.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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