Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma
NCT ID: NCT00003916
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
25 participants
INTERVENTIONAL
1999-04-30
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of standard radiation therapy with or without stereotactic radiation therapy in treating patients who have glioma.
Detailed Description
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OUTLINE: This is a randomized study. Patients are stratified according to WHO disease grade (III vs IV), center, and age (under 40 vs 40 and over). Patients are randomized to undergo stereotactic radiotherapy or no further treatment after conventional radiotherapy. Patients undergo conventional radiotherapy once or twice a day for up to 6 weeks. Patients randomized to receive additional treatment receive stereotactically guided conformal boost radiotherapy for 4 days, within 4 weeks after completion of conventional radiotherapy. Quality of life is assessed before radiotherapy, then at follow up visits. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 605 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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radiation therapy
stereotactic radiosurgery
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: WHO 0 or 1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Able to tolerate full course of conventional radiotherapy No prior or concurrent medical condition that would preclude study therapy No prior malignancies within 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No concurrent adjuvant chemotherapy Endocrine therapy: Concurrent steroids allowed Radiotherapy: See Disease Characteristics No prior radiotherapy to the head and neck area No prior radiotherapy to the brain No more than 6 weeks since other prior radiotherapy Surgery: See Disease Characteristics
18 Years
65 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Brigitta Baumert, MD, PhD
Role: STUDY_CHAIR
UniversitaetsSpital Zuerich
Locations
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Alfred Hospital
Melbourne, Victoria, Australia
Centre Antoine Lacassagne
Nice, , France
Medizinische Klinik I
Dresden, , Germany
Universitaet Wuerzburg/Hautkrankheiten
Würzburg, , Germany
Vrije Universiteit Medisch Centrum
Amsterdam, , Netherlands
Institut Catala d'Oncologia - Hospital Duran i Reynals
Barcelona, , Spain
Universitaetsspital
Zurich, , Switzerland
Royal Marsden Hospital
Sutton, England, United Kingdom
Countries
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References
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Baumert BG, Brada M, Bernier J, Kortmann RD, Dehing-Oberije C, Collette L, Davis JB. EORTC 22972-26991/MRC BR10 trial: fractionated stereotactic boost following conventional radiotherapy of high grade gliomas. Clinical and quality-assurance results of the stereotactic boost arm. Radiother Oncol. 2008 Aug;88(2):163-72. doi: 10.1016/j.radonc.2008.03.025. Epub 2008 Apr 30.
Brada M, Baumert B. Focal fractionated conformal stereotactic boost following conventional radiotherapy of high-grade gliomas: a randomized phase III study. A joint study of the EORTC (22972) and the MRC (BR10). Front Radiat Ther Oncol. 1999;33:241-3. doi: 10.1159/000061233. No abstract available.
Other Identifiers
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EORTC-22972
Identifier Type: -
Identifier Source: secondary_id
EORTC-26991
Identifier Type: -
Identifier Source: secondary_id
MRC-BR10
Identifier Type: -
Identifier Source: secondary_id
EORTC-22972-26991
Identifier Type: -
Identifier Source: org_study_id