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| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-26882 |
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RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for patients with anaplastic astrocytomas.
PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy in treating patients with anaplastic astrocytomas.
OBJECTIVES: I. Compare the disease-free interval and survival in patients with supratentorial malignant brain gliomas randomized to radiotherapy alone vs. radiotherapy plus radiosensitization with mitolactol (DBD) followed by DBD and carmustine.
OUTLINE: Randomized study. Group I: Radiotherapy. External-beam cranial irradiation with megavoltage equipment. Group II: Radiotherapy with Radiosensitization followed by Maintenance Chemotherapy. Radiotherapy as in Group I; with Mitolactol, DBD, NSC-104800; followed by DBD; Carmustine, BCNU, NSC-409962.
PROJECTED ACCRUAL: A total of 212 patients will be entered over more than 3 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carmustine | Drug | |||
| chemotherapy | Drug | |||
| mitolactol | Drug | |||
| low-LET cobalt-60 gamma ray therapy | Radiation | |||
| low-LET photon therapy | Radiation |
DISEASE CHARACTERISTICS: Histologically confirmed anaplastic astrocytoma Standard maximum resection or stereotactic biopsy required within 4 weeks prior to therapy
PATIENT CHARACTERISTICS: Age: Over 16 Performance status: ECOG/ZUBROD/WHO 0-2 Life expectancy: At least 8 weeks Hematopoietic: WBC greater than 4,000 Platelets greater than 100,000 Hematocrit greater than 30% Hepatic: Bilirubin less than 2 mg/dl Renal: Creatinine less than 1.5 mg/dl Creatinine clearance greater than 70 ml/min BUN less than 40 mg/dl Other: No major medical illness
PRIOR CONCURRENT THERAPY: No anticancer drugs between surgery and protocol treatment No steroids after 10 days following surgery (may be resumed occasionally during radiotherapy)
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| Name | Affiliation | Role |
|---|---|---|
| J. Hildebrand, MD | Erasme University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Franz Josef Hospital | Vienna (Wien) | A-1100 | Austria | |||
| Hopital Universitaire Erasme |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18248979 | Result | Hildebrand J, Gorlia T, Kros JM, Afra D, Frenay M, Omuro A, Stupp R, Lacombe D, Allgeier A, van den Bent MJ; EORTC Brain Tumour Group investigators. Adjuvant dibromodulcitol and BCNU chemotherapy in anaplastic astrocytoma: results of a randomised European Organisation for Research and Treatment of Cancer phase III study (EORTC study 26882). Eur J Cancer. 2008 Jun;44(9):1210-6. doi: 10.1016/j.ejca.2007.12.005. Epub 2008 Jan 14. | |
| 8058153 |
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| Brussels |
| 1070 |
| Belgium |
| Academisch Ziekenhuis der Vrije Universiteit Brussel | Brussels (Bruxelles) | 1090 | Belgium |
| Hopital Civil de Charleroi | Charleroi | 6000 | Belgium |
| Centre Hospitalier Regional de la Citadell | Liege (Luik) | 4000 | Belgium |
| Neurologische Klinik der Henriettenstiftung | Hanover | D-30559 | Germany |
| Regional Hospital Treviso | Treviso | 31100 | Italy |
| Rotterdam Cancer Institute | Rotterdam | 3075 EA | Netherlands |
| Dr. Bernard Verbeeten Instituut | Tilburg | 5042 SB | Netherlands |
| Academisch Ziekenhuis Utrecht | Utrecht | 3508 GA | Netherlands |
| Instituto Portugues de Oncologia de Francisco Gentil | Lisbon | 1093 | Portugal |
| Centre Hospitalier Universitaire Vaudois | Lausanne | CH-1011 | Switzerland |
| Nottingham City Hospital NHS Trust | Nottingham | England | NG5 1PB | United Kingdom |
| Southampton General Hospital | Southampton | England | SO16 6YD | United Kingdom |
| Result |
| Hildebrand J, Sahmoud T, Mignolet F, Brucher JM, Afra D. Adjuvant therapy with dibromodulcitol and BCNU increases survival of adults with malignant gliomas. EORTC Brain Tumor Group. Neurology. 1994 Aug;44(8):1479-83. doi: 10.1212/wnl.44.8.1479. |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D001254 | Astrocytoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D002330 | Carmustine |
| D004358 | Drug Therapy |
| D008936 | Mitolactol |
| ID | Term |
|---|---|
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D009603 | Nitroso Compounds |
| D013812 | Therapeutics |
| D004376 | Galactitol |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D002241 | Carbohydrates |
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