NCT00002670

Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer That Has Been Removed During Surgery

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 459 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	chemotherapy
DRUG	cisplatin
RADIATION	low-LET cobalt-60 gamma ray therapy
RADIATION	low-LET electron therapy
RADIATION	low-LET photon therapy

Timeline

• Start date: 1995-09-01
• Primary completion: 2002-07-01
• Completion: 2013-11-01
• First posted: 2004-06-10
• Last updated: 2014-01-24

Locations

23 sites across 2 countries: United States, South Africa