A Phase II Trial of Accelerated Radiotherapy Using Weekly Stereotactic Conformal Boosts For Supratentorial Glioblastoma Multiforme
Overview
- Phase
- Phase 2
- Intervention
- carmustine
- Conditions
- Brain and Central Nervous System Tumors
- Sponsor
- Radiation Therapy Oncology Group
- Enrollment
- 80
- Locations
- 236
- Primary Endpoint
- Overall Survival
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by carmustine in treating patients who have supratentorial glioblastoma multiforme.
Detailed Description
OBJECTIVES: * Determine the overall and progression-free survival in patients with supratentorial glioblastoma multiforme treated with accelerated radiotherapy and conformal stereotactic radiotherapy boost followed by carmustine. * Determine the short and long-term toxicity of this regimen in these patients. * Determine the feasibility of this regimen in these patients. OUTLINE: Patients receive daily accelerated radiotherapy 5 days a week on weeks 1-2. On weeks 3-6, patients receive accelerated radiotherapy 4 days a week (3 days a week on week 6) and conformal stereotactic radiotherapy boost once weekly. Patients then receive carmustine IV over 1-2 hours on days 1-3 every 8 weeks for 6 courses beginning within 1 month after the completion of radiotherapy. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within 15 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
External beam radiotherapy with stereotactic boost
External beam radiotherapy (EBXRT): 50 Gy in 25 daily fractions of 2 Gy. Stereotactic radiotherapy (SRT) boost: 4 treatments of 5 or 7 Gy, once per week during weeks 3-6. Patients will not receive EBXRT on the SRT treatment days.
Intervention: carmustine
External beam radiotherapy with stereotactic boost
External beam radiotherapy (EBXRT): 50 Gy in 25 daily fractions of 2 Gy. Stereotactic radiotherapy (SRT) boost: 4 treatments of 5 or 7 Gy, once per week during weeks 3-6. Patients will not receive EBXRT on the SRT treatment days.
Intervention: radiation therapy
External beam radiotherapy with stereotactic boost
External beam radiotherapy (EBXRT): 50 Gy in 25 daily fractions of 2 Gy. Stereotactic radiotherapy (SRT) boost: 4 treatments of 5 or 7 Gy, once per week during weeks 3-6. Patients will not receive EBXRT on the SRT treatment days.
Intervention: stereotactic radiosurgery
Outcomes
Primary Outcomes
Overall Survival
Time Frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.
Secondary Outcomes
- Progression-free Survival(From registration to date of progression, death or last follow-up. Analysis occurs at the same time as the primary outcome analysis.)