Observation Versus Conventional-Fractionated Radiotherapy or Radiosurgery After Non-radical Surgery for Benign Intracranial Meningiomas: A Phase III Study
- Compare progression-free survival of patients with newly diagnosed, incompletely
resected, benign intracranial grade I meningioma treated with adjuvant conventional
fractionated radiotherapy or radiosurgery vs observation only.
- Compare the quality of life of patients treated with these regimens.
- Compare overall survival of patients treated with these regimens.
- Compare the incidence of a second surgery in patients treated with these regimens.
- Compare the incidence of acute and long-term neurotoxicity in patients treated with
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.
- Arm I: Patients undergo observation only.
- Arm II: Within 4-7 months after surgery, patients undergo conventional fractionated
radiotherapy once daily, 5 days a week for 6 weeks OR a single treatment of high-dose
radiosurgery in the absence of unacceptable toxicity.
Quality of life is assessed at baseline, at 6 months after randomization, and then annually
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.
Allocation: Randomized, Primary Purpose: Treatment
John G. Wolbers, MD, PhD
University Medical Center Rotterdam at Erasmus Medical Center
United States: Federal Government