stereotactic radiosurgery and radiation therapy in treating patients with glioblastoma multiforme

Conditions: Brain and Central Nervous System Tumors

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 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.

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 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

Keywords: adult glioblastoma adult giant cell glioblastoma adult gliosarcoma