Stereotactic Radiosurgery and Radiation Therapy in Treating Patients With Glioblastoma Multiforme
|ClinicalTrials.gov Identifier: NCT00253448|
Recruitment Status : Completed
First Posted : November 15, 2005
Results First Posted : July 26, 2011
Last Update Posted : August 29, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Radiation: radiation therapy Radiation: stereotactic radiosurgery||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Conventional Radiotherapy With Stereotactic Radiosurgery to High Risk Tumor Regions as Determined by Functional Imaging in Patients With Glioblastoma Multiforme|
|Study Start Date :||December 2002|
|Primary Completion Date :||December 2009|
|Study Completion Date :||July 2011|
Radiation: radiation therapy
- Overall Survival After Treatment [ Time Frame: Minimum of 5 years. ]Followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter for at least 5 years
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253448
|United States, Ohio|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Southwest General Health Center|
|Cleveland, Ohio, United States, 44130|
|Principal Investigator:||Douglas Einstein, MD, PhD||Kettering Medical Center, Wright State University|