Observation Versus Conventional-Fractionated Radiotherapy or Radiosurgery After Non-radical Surgery for Benign Intracranial Meningiomas: A Phase III Study
Observation Versus Conventional-Fractionated Radiotherapy or Radiosurgery After Non-radical Surgery for Benign Intracranial Meningiomas: A Phase III Study
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving radiation therapy or radiosurgery after surgery may kill any remaining tumor cells. It is not yet known whether radiation therapy or radiosurgery is more effective than observation alone in treating benign meningioma.
PURPOSE: This randomized phase III trial is studying radiation therapy or radiosurgery to see how well they work compared to observation alone in treating patients with newly diagnosed, benign meningioma that has been partially removed by surgery.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to post-surgery MRI staging (3 vs 4 vs 5), skull base location (yes vs no), age (< 60 vs ≥ 60), and participating center. Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, at 6 months after randomization, and then annually thereafter.
After completion of study treatment, patients are followed at 3 and 6 months after randomization and then annually thereafter.
PROJECTED ACCRUAL: A total of 478 patients (239 per treatment arm) will be accrued for this study within 3-4 years.
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed benign intracranial meningioma
Mitotic index < 4 (total counts per 10 high-power field) AND MIB-1 labeling index < 4%
The following histologies are not allowed (i.e., WHO grade II or III):
Must have undergone non-radical resection* within the past 7 months
No brain invasion
No hemangiopericytoma
No fibrous dysplasia or intra-osseous meningioma
No multiple meningiomas or meningiomatosis
Not part of neurofibromatosis type II
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other