High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00002555
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 338
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Hopital Jean Bernard
🇫🇷Poitiers, France
Ciudad Sanitaria Vall D'Hebron
🇪🇸Barcelona, Spain
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
🇫🇷Dijon, France
Institut Jules Bordet
🇧🇪Brussels, Belgium
CHR de Grenoble - La Tronche
🇫🇷Grenoble, France
CRLCC Nantes - Atlantique
🇫🇷Nantes-Saint Herblain, France
Centre Oscar Lambret
🇫🇷Lille, France
Istituto Nazionale per lo Studio e la Cura dei Tumori
🇮🇹Milan, Italy
Institut Gustave Roussy
🇫🇷Villejuif, France
Istituti Fisioterapici Ospitalieri - Roma
🇮🇹Rome, Italy
Medical University of Gdansk
🇵🇱Gdansk, Poland
University Medical Center Nijmegen
🇳🇱Nijmegen, Netherlands
Institute of Oncology, Ljubljana
🇸🇮Ljubljana, Slovenia
Ospedale San Giovanni
🇨ðŸ‡Bellinzona, Switzerland
Inselspital, Bern
🇨ðŸ‡Bern, Switzerland
Dokuz Eylul University School of Medicine
🇹🇷Izmir, Turkey
Centre Hospitalier Universitaire Vaudois
🇨ðŸ‡Lausanne, Switzerland
Universitaetsspital
🇨ðŸ‡Zurich, Switzerland
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom