Phase II Trial of Conventional Radiotherapy With Stereotactic Radiosurgery to High Risk Tumor Regions as Determined by Functional Imaging in Patients With Glioblastoma Multiforme
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
Phase II Trial of Conventional Radiotherapy With Stereotactic Radiosurgery to High Risk Tumor Regions as Determined by Functional Imaging in Patients With Glioblastoma Multiforme
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed grade IV malignant glioblastoma multiforme
- Diagnosis by surgical biopsy or resection within the past 5 weeks
- Post-operative diagnostic contrast-enhanced MRI scan with MR spectroscopy must be
performed prior to initiating study treatment
- High-risk area of active tumor without margin by MR spectroscopy
- Meets the following criteria for radiosurgery:
- Maximum diameter ≤ 40 mm
- Located > 5 mm from the optic nerve or chiasm
- Does not involve the brainstem
- No multifocal or recurrent malignant glioma
PATIENT CHARACTERISTICS:
Performance status
- Karnofsky 50-100%
Life expectancy
- At least 3 months
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
Chemotherapy
- At least 6 weeks since chemotherapy
- Concurrent chemotherapy allowed
Endocrine therapy
- Concurrent steroids allowed, but at the smallest therapeutic dose possible
Radiotherapy
- No prior in-field radiotherapy to the head and neck
Surgery
- See Disease Characteristics
- Recovered from prior surgery or any post-operative complication
Other
- Concurrent antiseizure medications allowed
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival After Treatment
Outcome Description:
Followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter for at least 5 years
Outcome Time Frame:
Minimum of 5 years.
Safety Issue:
No
Principal Investigator
Douglas Einstein, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Kettering Medical Center, Wright State University
Authority:
United States: Federal Government
Study ID:
CWRU1302
NCT ID:
NCT00253448
Start Date:
December 2002
Completion Date:
July 2011
Related Keywords:
- Brain and Central Nervous System Tumors
- adult glioblastoma
- adult giant cell glioblastoma
- adult gliosarcoma
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
| Southwest General Health Center | Middleburgh Heights, Ohio 44130 |
