Stereotactic Radiosurgery and Radiation Therapy 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.

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