Stereotactic Radiosurgery and Radiation Therapy in Treating Patients With Glioblastoma Multiforme

Case Comprehensive Cancer Center (Case CCC)

Status and phase: Completed; Phase 2

Conditions: Brain and Central Nervous System Tumors

Treatments: Radiation: radiation therapy; Radiation: stereotactic radiosurgery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00253448

CWRU1302

P30CA043703 (U.S. NIH Grant/Contract)

CASE-CWRU-1302 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)