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Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery

NCT03180268 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2026-05-07

No results posted yet for this study

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.

Conditions

  • Grade 2 Meningioma
  • Intracranial Meningioma

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

OTHER

Clinical Observation

Undergo observation

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

RADIATION

Proton Beam Radiation Therapy

Undergo proton beam radiation therapy

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • NRG Oncology

    lead OTHER

Principal Investigators

  • Michael A Vogelbaum · NRG Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-12
Primary Completion
2027-06-15
Completion
2027-06-15

Countries

  • United States
  • Canada
  • India
  • Japan
  • Saudi Arabia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03180268 on ClinicalTrials.gov