Radiation Therapy With and Without Combination Chemotherapy in Patients With Resected Anaplastic Oligodendroglioma
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00002840
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells, and may be an effective treatment for anaplastic oligodendroglioma. Combining combination chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare radiation therapy with and without combination chemotherapy in patients with resected anaplastic oligodendroglioma.
- Detailed Description
OBJECTIVES: I. Compare survival and time to first progression in patients with anaplastic oligodendroglioma treated with radiotherapy with or without adjuvant procarbazine, lomustine, and vincristine (PCV) following surgical resection. II. Investigate the effect of PCV on quality of life and neurologic function in these patients. III. Determine the toxicity of PCV in these patients. IV. Correlate chromosomal lesions (1p and/or 19q, 9p, p53 loss and mutation, amplification of chromosome 7, or loss of chromosome 10) with progression-free and overall survival in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age, extent of resection, performance status, prior surgery, and participating center. Patients are randomized to one of two treatment arms. Arm I: Within 4-6 weeks after surgery, patients undergo radiotherapy over 7 weeks to the residual tumor volume. Arm II: Patients undergo radiotherapy as in arm I, then begin chemotherapy within 4 weeks after the completion of radiotherapy. Patients receive oral lomustine on day 1, oral procarbazine on days 8-21, and vincristine IV on days 8 and 29. Treatment repeats every 6 weeks in stable and responding patients for a total of 6 courses. Patients with disease recurrence may receive 6 additional courses of chemotherapy as above or another modality at the investigator's discretion. Patients are followed every 3 months for 1 year and then every 6 months for survival.
PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study within 4 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
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 (40)
CHU de la Timone
🇫🇷Marseille, France
CRLCC Nantes - Atlantique
🇫🇷Nantes-Saint Herblain, France
Hopital Universitaire Erasme
🇧🇪Brussels, Belgium
Hopital de Jolimont
🇧🇪Haine Saint Paul, Belgium
Hopital Pasteur
🇫🇷Nice, France
Centre Eugene Marquis
🇫🇷Rennes, France
Kaiser Franz Josef Hospital
🇦🇹Vienna (Wien), Austria
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Turku University Central Hospital
🇫🇮Turku, Finland
Centre Hospitalier Regional de Lille
🇫🇷Lille, France
CHU de Nancy - Hopital Neurologique
🇫🇷Nancy, France
Centre Antoine Lacassagne
🇫🇷Nice, France
C.H.R. de Nimes - Hopital Caremeau
🇫🇷Nimes, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Neurologische Klinik der Henriettenstiftung
🇩🇪Hannover, Germany
CHU Pitie-Salpetriere
🇫🇷Paris, France
National Institute of Neurosurgery
ðŸ‡ðŸ‡ºBudapest, Hungary
Azienda Ospedaliera di Padova
🇮🇹Padova (Padua), Italy
Klinikum der Friedrich-Schiller Universitaet Jena
🇩🇪Jena, Germany
Universita di Padova
🇮🇹Padova, Italy
University Medical Center Nijmegen
🇳🇱Nijmegen, Netherlands
Academisch Ziekenhuis Groningen
🇳🇱Groningen, Netherlands
Dr. Bernard Verbeeten Instituut
🇳🇱Tilburg, Netherlands
Academisch Ziekenhuis Utrecht
🇳🇱Utrecht, Netherlands
Umea Universitet
🇸🇪Umea, Sweden
Instituto Portugues de Oncologia de Francisco Gentil
🇵🇹Lisbon, Portugal
Centre Hospitalier Universitaire Vaudois
🇨ðŸ‡Lausanne, Switzerland
University Hospital of Linkoping
🇸🇪Linkoping, Sweden
Queen's Medical Centre
🇬🇧Nottingham, England, United Kingdom
Nottingham General Hospital
🇬🇧Nottingham, England, United Kingdom
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom
Royal Marsden Hospital
🇬🇧Sutton, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Academisch Ziekenhuis der Vrije Universiteit Brussel
🇧🇪Brussels (Bruxelles), Belgium
Vrije Universiteit Medisch Centrum
🇳🇱Amsterdam, Netherlands
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
Medisch Centrum Haaglanden
🇳🇱's-Gravenhage (Den Haag, The Hague), Netherlands
Rotterdam Cancer Institute
🇳🇱Rotterdam, Netherlands
St. Elisabeth Ziekenhuis
🇳🇱Tilburg, Netherlands
Royal South Hants Hospital
🇬🇧Southampton, England, United Kingdom