Status:
COMPLETED
Stereotactic Radiosurgery and Radiation Therapy in Treating Patients With Glioblastoma Multiforme
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ster...
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. * Determi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00253448
Start Date
December 1 2002
End Date
July 1 2011
Last Update
August 29 2011
Active Locations (2)
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1
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
2
Southwest General Health Center
Cleveland, Ohio, United States, 44130