Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00003888
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for advanced head and neck cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy plus radiation therapy in treating patients who have advanced head and neck cancer.
- Detailed Description
OBJECTIVES: I. Compare the progression free survival of patients with locally advanced, inoperable squamous cell carcinoma of the head and neck treated with cisplatin plus fluorouracil with or without docetaxel as a neoadjuvant to radiotherapy. II. Compare the response rate, response duration, toxicity, local symptoms, and time to disease progression of these treatment regimens in this patient population. III. Evaluate the quality of life in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to primary tumor site (oral cavity vs oropharynx vs hypopharynx vs larynx) and institution. Patients are randomized to one of two treatment arms. Arm I: Patients receive docetaxel IV over 1 hour, immediately followed by cisplatin IV over 1 hour on day 1 and fluorouracil (5-FU) IV as a continuous infusion on days 1-5. Arm II: Patients receive cisplatin IV over 1 hour on day 1 followed by 5-FU IV as a continuous infusion on days 1-5. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients receive radiotherapy following chemotherapy within 3-6 weeks of last course. Radiotherapy is administered 5 days a week for up to 7 weeks. Quality of life is assessed before treatment, at courses 2 and 4, and at 6 and 9 months. Patients are followed every 3 months for the first 2 years and then every 6 months until death.
PROJECTED ACCRUAL: A total of 348 patients will be accrued for this study within 24 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 359
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 (44)
Institute of Oncology and Radiology of Serbia
Belgrade, Former Yugoslavia
CHR de Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
Centre Hospital Regional Universitaire de Limoges
🇫🇷Limoges, France
Centre Oscar Lambret
🇫🇷Lille, France
Centre Leon Berard
🇫🇷Lyon, France
CRLCC Nantes - Atlantique
🇫🇷Nantes-Saint Herblain, France
CHR Hotel Dieu
🇫🇷Nantes, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Martin Luther Universitaet
🇩🇪Halle, Germany
Caritasklinik St. Theresia
🇩🇪Saarbrucken, Germany
Mutterhaus der Borromaerinnen
🇩🇪Trier, Germany
National Institute of Oncology
ðŸ‡ðŸ‡ºBudapest, Hungary
Centro di Riferimento Oncologico - Aviano
🇮🇹Aviano, Italy
Ospedale Santa Croce
🇮🇹Cuneo, Italy
Istituti Fisioterapici Ospitalieri - Roma
🇮🇹Rome, Italy
Ospedale di Circolo e Fondazione Macchi
🇮🇹Varese, Italy
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Academisch Ziekenhuis Maastricht
🇳🇱Maastricht, Netherlands
Institut Catala d'Oncologia - Hospital Duran i Reynals
🇪🇸Barcelona, Spain
Hospital General de Jerez
🇪🇸Jerez, Spain
Universidad de Santiago - Hospital de Conxo
🇪🇸Santiago de Compostela, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Landeskrankenhaus/Universitatskliniken Graz
🇦🇹Graz, Austria
Allgemeines Krankenhaus der Stadt Wien
🇦🇹Vienna, Austria
Kaiser Franz Josef Hospital
🇦🇹Vienna, Austria
Institut Jules Bordet
🇧🇪Brussels, Belgium
Centre Hospitalier Regional de la Citadelle
🇧🇪Liege, Belgium
Algemeen Ziekenhuis Middelheim
🇧🇪Antwerp, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Clinique Universitaire De Mont-Godinne
🇧🇪Mont-Godinne Yvoir, Belgium
Ahepa University Hospital
🇬🇷Thessaloniki, Greece
Borsod-Abauj-Zemplen County Hospital
ðŸ‡ðŸ‡ºMiskolc, Hungary
Szent Margit Hospital
ðŸ‡ðŸ‡ºBudapest, Hungary
University Medical Center Nijmegen
🇳🇱Nijmegen, Netherlands
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
🇵🇱Warsaw, Poland
National Cancer Institute - Bratislava
🇸🇰Bratislava, Slovakia
Ospedale San Giovanni
🇨ðŸ‡Bellinzona, Switzerland
Istanbul University-Institute of Oncology
🇹🇷Istanbul, Turkey
Kantonspital Aarau
🇨ðŸ‡Aarau, Switzerland
Middlesex Hospital- Meyerstein Institute
🇬🇧London, England, United Kingdom
Newcastle General Hospital
🇬🇧Newcastle Upon Tyne, England, United Kingdom
Beatson Oncology Centre
🇬🇧Glasgow, Scotland, United Kingdom
Charing Cross Hospital
🇬🇧London, England, United Kingdom