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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Enrollment
338
Institut Jules Bordet
Brussels, Belgium
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, France
CHR de Grenoble - La Tronche
Grenoble, France
Centre Oscar Lambret
Lille, France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France
Hopital Jean Bernard
Poitiers, France
Institut Gustave Roussy
Villejuif, France
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milan, Italy
Istituti Fisioterapici Ospitalieri - Roma
Rome, Italy
University Medical Center Nijmegen
Nijmegen, Netherlands
...and 9 more locations
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