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Radiation Therapy With and Without Combination Chemotherapy in Patients With Resected Anaplastic Oligodendroglioma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Radiation Therapy With and Without Combination Chemotherapy in Patients With Resected Anaplastic Oligodendroglioma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Radiation Therapy With and Without Combination Chemotherapy in Patients With Resected Anaplastic Oligodendroglioma Clinical research trials and Radiation Therapy With and Without Combination Chemotherapy in Patients With Resected Anaplastic Oligodendroglioma healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Radiation Therapy With and Without Combination Chemotherapy in Patients With Resected Anaplastic Oligodendroglioma. Radiation Therapy With and Without Combination Chemotherapy in Patients With Resected Anaplastic Oligodendroglioma Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Radiation Therapy With and Without Combination Chemotherapy in Patients With Resected Anaplastic Oligodendroglioma clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Radiation Therapy With and Without Combination Chemotherapy in Patients With Resected Anaplastic Oligodendroglioma condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiation Therapy With and Without Combination Chemotherapy in Patients With Resected Anaplastic Oligodendroglioma  Radiation Therapy With and Without Combination Chemotherapy in Patients With Resected Anaplastic Oligodendroglioma
Radiation Therapy With and Without Combination Chemotherapy in Patients With Resected Anaplastic Oligodendroglioma
For Condition: Mixed Gliomas,adult anaplastic oligodendroglioma,recurrent adult brain tumor
Status: No longer recruiting
Sponsor(s): EORTC Brain Tumor Cooperative Group , Medical Research Council
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/69 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Newly diagnosed oligodendroglioma or oligoastrocytoma (with at least 25% oligodendral elements); Low-grade oligodendroastrocytoma or oligodendroglioma that is recurrent after surgery without radiotherapy is allowed - Prior partial or gross total resection of tumor (or biopsy only in case of no further surgical option) required - At least 3 of the following histologic anaplastic features: High cellularity; Endothelial abnormalities; Nuclear abnormalities; Necrosis Mitoses --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; No prior radiotherapy to the skull - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: 16 to 69 - Performance status: ECOG 0-2 - Life expectancy: At least 3 months - Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.4 mg/dL - Renal: Creatinine no greater than 1.3 mg/dL; Creatinine clearance at least 60 mL/min - Other: Not pregnant or nursing Fertile patients must use effective contraception; No active or uncontrolled infection; No other disease, including malignancy, that would preclude study; No neurologic or psychiatric disturbance that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Martinvan Den Bent, Study Chair, EORTC Brain Tumor Cooperative Group
Academisch Medisch Centrum
Amsterdam, , 1105 AZ
Netherlands
University Hospital of Linkoping
Linkoping, , S-581 85
Sweden
Klinikum der Friedrich-Schiller Universitaet Jena
Jena, , D-07740
Germany
Medisch Centrum Haaglanden
's-Gravenhage (Den Haag, The Hague), , 2501 CK
Netherlands
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
United Kingdom
Academisch Ziekenhuis Groningen
Groningen, , 9713 EZ
Netherlands
Centre Eugene Marquis
Rennes, , 35064
France
St. Elisabeth Ziekenhuis
Tilburg, , 5022 GC
Netherlands
CHU de la Timone
Marseille, , 13385
France
Academisch Ziekenhuis Utrecht
Utrecht, , 3584 CX
Netherlands
CHU de Nancy - Hopital Neurologique
Nancy, , 54035
France
Dr. Bernard Verbeeten Instituut
Tilburg, , 5042 SB
Netherlands
Centre Hospitalier Universitaire Vaudois
Lausanne, , CH-1011
Switzerland
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
Rotterdam Cancer Institute
Rotterdam, , 3075 EA
Netherlands
Umea Universitet
Umea, , S-901 85
Sweden
Kaiser Franz Josef Hospital
Vienna (Wien), , A-1100
Austria
Turku University Central Hospital
Turku, , FIN-2-0521
Finland
Azienda Ospedaliera di Padova
Padova (Padua), , 35128
Italy
Vrije Universiteit Medisch Centrum
Amsterdam, , 1001HV
Netherlands
CHU Pitie-Salpetriere
Paris, , 75651
France
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels (Bruxelles), , 1090
Belgium
Nottingham General Hospital
Nottingham, England, NG1 6HA
United Kingdom
Hopital Pasteur
Nice, , 06002
France
Queen's Medical Centre
Nottingham, England, NG7 2UH
United Kingdom
National Institute of Neurosurgery
Budapest, , 1145
Hungary
Southampton General Hospital
Southampton, England, SO16 6YD
United Kingdom
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, , 1093
Portugal
University Medical Center Nijmegen
Nijmegen, , NL-6500 HB
Netherlands
C.H.R. de Nimes - Hopital Caremeau
Nimes, , 30000
France
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Universita di Padova
Padova, , 35128
Italy
Neurologische Klinik der Henriettenstiftung
Hannover, , D-30559
Germany
Royal Marsden Hospital
Sutton, England, SM2 5PT
United Kingdom
Institut Gustave Roussy
Villejuif, , F-94805
France
Hopital de Jolimont
Haine-Saint-Paul, , 7100
Belgium
Centre Hospitalier Regional de Lille
Lille, , 59037
France
Royal South Hants Hospital
Southampton, England, SO14 0YG
United Kingdom
Centre Antoine Lacassagne
Nice, , 06189
France
Hopital Universitaire Erasme
Brussels, , 1070
Belgium
Additional Information:
Study ID Numbers: CDR0000065057; EORTC-26951,MRC-BR11
Study Start Date: August 1996
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002840
Other Mixed Gliomas Studies:
1. Temozolomide and Carmustine in Treating Patients With Anaplastic Glioma
2. Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma
3. Phosphorus 32 in Treating Patients With Glioblastoma Multiforme
4. Biological Therapy in Treating Patients With Primary or Advanced Glioma
5. Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma
Related Studies:
Other Mixed Gliomas Clinical Trials
Other Clinical Trials
Other Rotterdam Clinical Trials
Radiation Therapy With and Without Combination Chemotherapy in Patients With Resected Anaplastic Oligodendroglioma
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