Phase II Trial of Conventional Radiotherapy With Stereotactic Radiosurgery to High Risk Tumor Regions as Determined by Functional Imaging in Patients With Glioblastoma Multiforme
- 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
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
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival After Treatment
Followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter for at least 5 years
Minimum of 5 years.
Douglas Einstein, MD, PhD
Kettering Medical Center, Wright State University
United States: Federal Government
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Southwest General Health Center||Middleburgh Heights, Ohio 44130|