Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma
NRG Oncology
Summary
This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.
Description
PRIMARY OBJECTIVE: I. To determine the extent of clinical benefit of the addition of adjuvant radiotherapy (RT) to gross total resection (GTR) for patients with newly diagnosed World Health Organization (WHO) grade II meningioma. SECONDARY OBJECTIVES: I. Overall survival (OS). II. Disease-specific survival (DSS). III. Toxicity (grade 3+, exclusive of expected alopecia). IV. Neurocognitive function (NCF). V. Patient reported outcomes (PRO) measurements. VI. Adherence to protocol-specific target and normal tissue parameters. VII. Concordance measurements of central versus parent-institution p…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * 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…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- OtherClinical Observation
Undergo observation
- RadiationIntensity-Modulated Radiation Therapy
Undergo IMRT
- OtherLaboratory Biomarker Analysis
Correlative studies
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- RadiationProton Beam Radiation Therapy
Undergo proton beam radiation therapy
- OtherQuality-of-Life Assessment
Locations (214)
- University of Alabama at Birmingham Cancer CenterBirmingham, Alabama
- Saint Joseph's Hospital and Medical CenterPhoenix, Arizona
- Mayo Clinic Hospital in ArizonaPhoenix, Arizona
- Mayo Clinic in ArizonaScottsdale, Arizona
- University of Arizona Cancer Center-Orange Grove CampusTucson, Arizona
- Banner University Medical Center - TucsonTucson, Arizona