Study ID: NRG BN003
Phase III trial of observation vs. irradiation for a totally resected grade II meningioma
Researchers seek to determine if radiation therapy following surgery can improve the outcomes in patients who have been diagnosed with grade II meningioma, a tumor that arises from the membranes that surround the brain and spinal cord.
- Newly diagnosed unifocal intracranial meningioma, gross totally resected, and histologically confirmed as WHO grade II based upon pathology findings at the enrolling institution.
- For step 1 registration, the operating neurosurgeon must provide the modified Simpson grade (1–3). GTR must be confirmed on post-op imaging following the most recent surgery; pre- and post-operative MRIs are required for patient (see protocol for specifics if second surgery occurs).
- Prior to step 2, diagnosis of WHO grade II meningioma confirmed by central pathology review.
See protocol document for complete eligibility requirements, including specific imaging needs.
- Arm 1: Clinical observation after gross total resection
- Arm 2: Radiation therapy 5 days per week over 6.5 or 7 weeks for a total of 33 treatments
- Must have been diagnosed with grade II meningioma and already undergone surgical removal of the tumor
- Must be willing to undergo radiation therapy and follow-up care for up to 10 years