NCT00002555

High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer

A PHASE III RANDOMIZED STUDY ON POSTOPERATIVE RADIO- AND CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED HEAD AND NECK CARCINOMAS

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 338 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years – 70 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 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.

Detailed description

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.

Conditions

• Head and Neck Cancer

Interventions

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

Timeline

• Start date: 1994-02-01
• Primary completion: 2000-10-01
• First posted: 2004-05-26
• Last updated: 2012-07-02

Locations

19 sites across 10 countries: Belgium, France, Italy, Netherlands, Poland, Slovenia, Spain, Switzerland, Turkey (Türkiye), United Kingdom