Stereotactic Radiosurgery and Radiation Therapy in Treating Patients With Glioblastoma Multiforme
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Radiation: radiation therapy Radiation: stereotactic radiosurgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Overall Survival After Treatment [ Time Frame: Minimum of 5 years. ] [ Designated as safety issue: No ]Followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter for at least 5 years
| Enrollment: | 35 |
| Study Start Date: | December 2002 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
-
Radiation: radiation therapy
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided by Case Comprehensive Cancer Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00253448 History of Changes |
| Other Study ID Numbers: | CWRU1302, P30CA043703, CASE-CWRU-1302 |
| Study First Received: | November 11, 2005 |
| Results First Received: | June 29, 2011 |
| Last Updated: | August 25, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Case Comprehensive Cancer Center:
|
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
|
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013