Spots Global Cancer Trial Database for Radiation Therapy With and Without Combination Chemotherapy in Patients With Resected Anaplastic Oligodendroglioma
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Trial Identification
Brief Title: Radiation Therapy With and Without Combination Chemotherapy in Patients With Resected Anaplastic Oligodendroglioma
Official Title: PHASE III STUDY OF ADJUVANT PROCARBAZINE, CCNU AND VINCRISTINE CHEMOTHERAPY IN PATIENTS WITH HIGHLY ANAPLASTIC OLIGODENDROGLIOMA
Study ID: NCT00002840
Conditions
Study Description
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.
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Kaiser Franz Josef Hospital, Vienna (Wien), , Austria
Academisch Ziekenhuis der Vrije Universiteit Brussel, Brussels (Bruxelles), , Belgium
Hopital Universitaire Erasme, Brussels, , Belgium
Hopital de Jolimont, Haine Saint Paul, , Belgium
U.Z. Gasthuisberg, Leuven, , Belgium
Turku University Central Hospital, Turku, , Finland
Centre Hospitalier Regional de Lille, Lille, , France
CHU de la Timone, Marseille, , France
CHU de Nancy - Hopital Neurologique, Nancy, , France
CRLCC Nantes - Atlantique, Nantes-Saint Herblain, , France
Hopital Pasteur, Nice, , France
Centre Antoine Lacassagne, Nice, , France
C.H.R. de Nimes - Hopital Caremeau, Nimes, , France
CHU Pitie-Salpetriere, Paris, , France
Centre Eugene Marquis, Rennes, , France
Institut Gustave Roussy, Villejuif, , France
Neurologische Klinik der Henriettenstiftung, Hannover, , Germany
Klinikum der Friedrich-Schiller Universitaet Jena, Jena, , Germany
National Institute of Neurosurgery, Budapest, , Hungary
Azienda Ospedaliera di Padova, Padova (Padua), , Italy
Universita di Padova, Padova, , Italy
Medisch Centrum Haaglanden, 's-Gravenhage (Den Haag, The Hague), , Netherlands
Vrije Universiteit Medisch Centrum, Amsterdam, , Netherlands
Academisch Medisch Centrum, Amsterdam, , Netherlands
Academisch Ziekenhuis Groningen, Groningen, , Netherlands
University Medical Center Nijmegen, Nijmegen, , Netherlands
Rotterdam Cancer Institute, Rotterdam, , Netherlands
St. Elisabeth Ziekenhuis, Tilburg, , Netherlands
Dr. Bernard Verbeeten Instituut, Tilburg, , Netherlands
Academisch Ziekenhuis Utrecht, Utrecht, , Netherlands
Instituto Portugues de Oncologia de Francisco Gentil, Lisbon, , Portugal
University Hospital of Linkoping, Linkoping, , Sweden
Umea Universitet, Umea, , Sweden
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Nottingham General Hospital, Nottingham, England, United Kingdom
Nottingham City Hospital NHS Trust, Nottingham, England, United Kingdom
Queen's Medical Centre, Nottingham, England, United Kingdom
Royal South Hants Hospital, Southampton, England, United Kingdom
Southampton General Hospital, Southampton, England, United Kingdom
Royal Marsden Hospital, Sutton, England, United Kingdom
Contact Details
Name: Martin J. van Den Bent, MD
Affiliation: Daniel Den Hoed Cancer Center at Erasmus Medical Center
Role: STUDY_CHAIR
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