NCT00253448

Stereotactic Radiosurgery and Radiation Therapy in Treating Patients With Glioblastoma Multiforme

Phase II Trial of Conventional Radiotherapy With Stereotactic Radiosurgery to High Risk Tumor Regions as Determined by Functional Imaging in Patients With Glioblastoma Multiforme

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving stereotactic radiosurgery together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving stereotactic radiosurgery together with radiation therapy works in treating patients with glioblastoma multiforme.

Detailed description

OBJECTIVES: Primary * Determine the feasibility and efficacy of stereotactic radiosurgery to high-risk tumor regions and conventional radiotherapy in patients with glioblastoma multiforme. * Determine overall survival of patients treated with this regimen. Secondary * Determine 6-month progression-free survival of patients treated with this regimen. * Determine the absence of tumor growth and/or activity on conventional MR/MR spectroscopy imaging in patients treated with this regimen. * Determine the frequency and severity of RTOG (Radiation Therapy Oncology Group) CNS toxic effects in patients treated with this regimen. * Determine the neurologic function and quality of life of patients treated with this regimen. OUTLINE: This is a pilot study. Patients undergo stereotactic radiosurgery to high-risk areas of active tumor determined by MR-spectroscopy. No more than 2 weeks later, patients undergo conventional radiotherapy once daily, 5 days a week, for 6 weeks. Quality of life is assessed at baseline, weekly during radiotherapy, at 1 and 3 months after completion of radiotherapy, and then every 3 months for 2 years, every 6 months for 3 years, and annually thereafter. After completion of study treatment, patients are followed periodically for at least 5 years. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
RADIATION	radiation therapy	No more than 2 weeks later, patients undergo conventional radiotherapy once daily, 5 days a week, for 6 weeks.
RADIATION	stereotactic radiosurgery	stereotactic radiosurgery to high-risk areas of active tumor determined by MR-spectroscopy

Timeline

• Start date: 2002-12-01
• Primary completion: 2009-12-01
• Completion: 2011-07-01
• First posted: 2005-11-15
• Last updated: 2011-08-29
• Results posted: 2011-07-26

Locations

2 sites across 1 country: United States