Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00003627
- Lead Sponsor
- UNICANCER
- 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. Combining chemotherapy with radiation therapy may kill more tumor cells and allow doctors to preserve the part of the body where the cancer started. It is not yet known whether radiation therapy with combination chemotherapy is more effective than radiation therapy alone in treating cancer of the oropharynx or hypopharynx that cannot be surgically removed.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin and fluorouracil with radiation therapy alone in treating patients who have advanced cancer of the oropharynx or hypopharynx that cannot be surgically removed.
- Detailed Description
OBJECTIVES:
* Compare the overall survival and survival without relapse for 1, 3, and 5 years of patients with squamous cell cancer of the oropharynx or hypopharynx after treatment with twice a day radiotherapy with or without cisplatin and fluorouracil.
* Compare the presence of distant metastases at 1, 3, and 5 years in these patients after these treatments.
* Compare the local control and duration of control in these patients after these treatments.
* Compare the clinical changes and histological changes at 6 months in these patients after these treatments.
* Determine the rate of complete response in these patients after these treatments.
* Determine the early and late toxic effects of these regimens in these patients.
* Determine the quality of life of these patients.
* Determine the pharmacokinetics of fluorouracil and tolerability of this regimen in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and primary site of disease (oropharynx vs hypopharynx)
Patients are randomized to one of two treatment arms.
* Arm I: Patients undergo radiotherapy twice a day, 6 hours apart, 5 days a week, for 7 weeks.
* Arm II: Patients undergo radiotherapy as in arm I, plus concurrent chemotherapy consisting of cisplatin IV on day 1 and fluorouracil by continuous infusion over 24 hours on days 1-5. Courses are repeated every 3 weeks for 3 courses.
Patients are followed every month for 1 year, every 2-3 months for 2 years, then every 6 months for at least 2 years.
PROJECTED ACCRUAL: A total of 160 patients (80/arm) will be accrued for this study within 4.5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
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 (11)
Centre Antoine Lacassagne
🇫🇷Nice, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Institut Jean Godinot
🇫🇷Reims, France
Centre Hospitalier Universitaire Bretonneau de Tours
🇫🇷Tours, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
Centre Henri Becquerel
🇫🇷Rouen, France
Centre Oscar Lambret
🇫🇷Lille, France
Institut J. Paoli and I. Calmettes
🇫🇷Marseille, France
CHU de la Timone
🇫🇷Marseille, France
CRLCC Nantes - Atlantique
🇫🇷Nantes-Saint Herblain, France
Centre Rene Huguenin
🇫🇷Saint Cloud, France