RTOG-0539

Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas

Principal Investigator

C. Leland Rogers

Status

Disease Site

Brain [BN] Other

Phase

II

Developmental Therapeutics

No

Primary Objective

To estimate the rates of progression-free survival (PFS) at 3 years in each of the patient risk groups.

Patient Population

Histopathologically confirmed meningioma, confirmed by central pathology review prior to STEP 2 registration. Risk categories are defined as follows:

 
• Low (Group I): Patients with a newly diagnosed gross totally resected (Simpson’s grade I, II, or III resections with no residual nodular enhancement on postoperative imaging) or subtotally resected (residual nodular enhancement or Simpson grade IV or V excision) World Health Organization (WHO) grade I meningioma. The extent of resection will be based upon the neurosurgeon’s assessment and postoperative MR imaging.

 

• Intermediate (Group II): Patients with a newly diagnosed gross totally resected WHO grade II meningioma or a recurrent WHO grade I meningioma irrespective of the resection extent. Resection extent will be assessed according to Simpson’s grade on the same basis described above for the low-risk group.

 

• High (Group III): Patients with high-risk features including a newly diagnosed or recurrent WHO grade III meningioma of any resection extent; a recurrent WHO grade II meningioma of any resection extent; or a newly diagnosed subtotally resected WHO grade II meningioma. Resection extent will be recorded on the same basis described above for the low-risk group.

Target Accrual

165