Comparing Clinical Observation with Intensity-Modulated Radiation Therapy for grade 2 meningioma

Inclusion

• +Gross total resection (GTR) will be interpreted as modified Simpson grade 1-3 without gross residual dural-based or extradural tumor. GTR must be confirmed both by modified Simpson grade and by post-operative magnetic resonance imaging (MRI) findings. The modified Simpson grade can be inferred from the operative report (surgeon does not need to explicitly describe the Simpson grade for the purposes of eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more →)
• +Post-operative Zubrod performance status 0-1 within 60 days prior to step 2 registration
• +PRIOR TO STEP 1 REGISTRATION:
• +The patient must have a newly diagnosed unifocal intracranial meningioma, gross totally resected, and histologically confirmed as WHO grade II based upon pathology findings at the enrolling institution. WHO grade will be assigned according to WHO 2016 criteria
• +The patient or a legally authorized representative must provide study-specific informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → prior to study entry
• +NOTE: Central pathology review must occur between steps 1 and 2 of registration. Once appropriate pathology specimens are received, central pathology review will occur within 10 business days, and must confirm WHO grade II meningioma before the patient can proceed to step 2 registration and randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
• +PRIOR TO STEP 2 REGISTRATION:
• +Histologically confirmed diagnosis of WHO grade II meningioma confirmed by central pathology review prior to step 2 registration
• +Age \>= 18
• +History/physical examination, including neurologic examination within 60 days prior to step 2 registration
• +Step 1 registration must occur within 180 days of the initial surgery; this will provide sufficient time for post-operative imaging confirmation of resection extent after resolution of operative changes. Moreover, it will permit additional surgery if needed to achieve a GTR. Within this 180 day interval, a second surgery is permitted in order to achieve GTR, but even with a second surgery, Step 1 registration must occur within 180 days of the initial resection
• +GTR must be confirmed on post-operative imaging following the most recent surgery. For protocolProtocolThe detailed plan a study must follow.Read more → enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →, the assessment of GTR will be made at each siteTrial siteA hospital or clinic where a study is actually run.Read more →. However, submission of both pre-operative and post-operative MRIs is required for patients. If a second surgery is performed, submission of post-operative MRI is required and pre-operative MRI is required only if obtained. All sequences obtained in the pre- and post-operative MR imaging are to be submitted to National Radiology Group (NRG) Oncology for study registration. The post-operative MRI must be completed within sufficient time to permit step 1 registration within 180 days of the initial resection. These same conditions apply in the setting of a second surgical procedure, although if a second surgery is completed, step 1 registration must still occur with 180 days of initial surgery. Computed tomography (CT) imaging is not required, but may be obtained if desired clinically, for instance to assess calcifications or hyperostosis
• +If the patient is a woman is of childbearing potential, a serum pregnancy test, obtained within 14 days prior to step 2 registration, must be negative, and, if randomized to receive radiation therapy, the woman must agree to use contraception