CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 163 target
Drug / intervention
Biospecimen Collection +6 moreprocedure
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Newly diagnosed unifocal intracranial meningioma, gross totally resected, WHO grade II histologically confirmed
  • ✓Gross total resection interpreted as modified Simpson grade 1-3 without gross residual dural-based or extradural tumor, confirmed by Simpson grade and post-operative MRI
  • ✓Step 1 registration within 180 days of initial surgery
  • ✓Central pathology review confirms WHO grade II meningioma before Step 2 registration
Key exclusion· 11
  • ✕Optic nerve sheath meningioma, spinal or extracranial meningioma, multiple meningiomas, hemangiopericytoma
  • ✕Definitive evidence of metastatic meningioma
  • ✕Prior invasive malignancy except non-melanomatous skin cancer unless disease-free ≥3 years
  • ✕Previous radiotherapy to scalp, cranium, brain, or skull base; radiation-induced meningiomas

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT03180268Phase 3RecruitingOn Track
Long Recruiting
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Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma

NRG Oncology·interventional·Posted Jun 8, 2017·Updated Jun 25, 2026

In Brief

A Phase 3 clinical trial evaluating Biospecimen Collection, Clinical Observation, and 5 other interventions for Grade 2 Meningioma and Intracranial Meningioma. Currently recruiting, targeting 163 participants across 215 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGrade 2 Meningioma, Intracranial Meningioma
CountriesCanada, India, Japan, Saudi Arabia, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3Recruiting
2018201920202021202220232024202520262027
First PostedJun 8, 2017
Enrollment StartSep 12, 2017
Primary CompletionJun 15, 2027
TodayJul 2, 2026
Enrollment to primary: 9.8 yearsPosted 9.1 years agoPrimary completion in 11 months

Arms & Interventions

Arm I (observation)active_comparator

Patients undergo observation. Additionally, patients undergo MRI and blood collection throughout the study.

Procedure: Biospecimen CollectionOther: Clinical ObservationOther: Laboratory Biomarker AnalysisProcedure: Magnetic Resonance ImagingOther: Quality-of-Life Assessment
Arm II (radiation therapy)experimental

Patients undergo IMRT or proton beam radiation therapy 5 days a week over 6.5-7 weeks for a total of 33 fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and blood collection throughout the study.

Procedure: Biospecimen CollectionRadiation: Intensity-Modulated Radiation TherapyOther: Laboratory Biomarker AnalysisProcedure: Magnetic Resonance ImagingRadiation: Proton Beam Radiation TherapyOther: Quality-of-Life Assessment

Interventions

Biospecimen Collectionprocedure

Undergo collection of blood samples

Clinical Observationother

Undergo observation

Intensity-Modulated Radiation Therapyradiation

Undergo IMRT

Laboratory Biomarker Analysisother

Correlative studies

Magnetic Resonance Imagingprocedure

Undergo MRI

Proton Beam Radiation Therapyradiation

Undergo proton beam radiation therapy

Quality-of-Life Assessmentother

Ancillary studies