Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00003916
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for patients with glioma. Stereotactic radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known if standard radiation therapy is more effective when followed by stereotactic radiation therapy.
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
OBJECTIVES: I. Compare the effect of adjuvant conventional radiotherapy with or without fractionated stereotactic boost radiotherapy on survival in patients with high grade glioma. II. Compare the quality of life of these patients after these therapies.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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 (8)
Medizinische Klinik I
🇩🇪Dresden, Germany
Institut Catala d'Oncologia - Hospital Duran i Reynals
🇪🇸Barcelona, Spain
Universitaetsspital
🇨ðŸ‡Zurich, Switzerland
Universitaet Wuerzburg/Hautkrankheiten
🇩🇪Wuerzburg, Germany
Centre Antoine Lacassagne
🇫🇷Nice, France
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Vrije Universiteit Medisch Centrum
🇳🇱Amsterdam, Netherlands
Royal Marsden Hospital
🇬🇧Sutton, England, United Kingdom