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

Conditions

• Grade 2 Meningioma
• Intracranial Meningioma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood samples
• Clinical Observation — OTHER
  Undergo observation
• Intensity-Modulated Radiation Therapy — RADIATION
  Undergo IMRT
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Proton Beam Radiation Therapy — RADIATION
  Undergo proton beam radiation therapy
• Quality-of-Life Assessment — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Sep 12, 2017

Status verified

Jan 2026

Primary completion

Jun 15, 2027

Completion

Jun 15, 2027

Study Design

Enrollment

163 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (observation)
  Patients undergo observation. Additionally, patients undergo MRI and blood collection throughout the study.
• Experimental: Arm II (radiation therapy)
  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.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: From randomization to the first documented disease progression, or death due to any cause, whichever comes first, assessed up to 10 years ]

Locations (197)

Find similar trials in Birmingham, AL

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