Stereotactic Radiosurgery and Radiation Therapy in Treating Patients With Glioblastoma Multiforme

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Trial of Conventional Radiotherapy With Stereotactic Radiosurgery to High Risk Tumor Regions as Determined by Functional Imaging in Patients With Glioblastoma Multiforme

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Radiation: radiation therapy
* Radiation: stereotactic radiosurgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: radiation therapy|No more than 2 weeks later, patients undergo conventional radiotherapy once daily, 5 days a week, for 6 weeks.|
|Radiation: stereotactic radiosurgery|stereotactic radiosurgery to high-risk areas of active tumor determined by MR-spectroscopy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma