NCT00895622

Observation or Radiation Therapy in Treating Patients With Grade I, Grade II, or Grade III Meningioma

Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor, such as 3-dimensional conformal radiation therapy and intensity-modulated radiation therapy, may kill more tumor cells and cause less damage to normal tissue. It is not yet known whether observation is more effective than radiation therapy in treating patients with meningioma. PURPOSE: This phase II trial is studying observation to see how well it works compared with radiation therapy in treating patients with grade I, grade II, or grade III meningioma.

Detailed description

OBJECTIVES: Primary * To estimate the rates of progression-free survival at 3 years in patients with low-risk meningioma undergoing observation and in patients with intermediate- or high-risk meningioma undergoing radiotherapy. Secondary * To study the concordance, or lack thereof, between central and parent institution histopathologic diagnosis, grading, and subtyping. * To estimate the rates of overall survival at 3 years in these patients. * To estimate the incidence rates of acute and late adverse events ≥ grade 2 in patients with intermediate- or high-risk meningioma undergoing radiotherapy. * To evaluate MRI imaging predictors by central neuroradiology review at diagnosis, at any failure, and at 3 years. * To evaluate adherence to protocol-specific target and normal tissue radiotherapy parameters. This is a multicenter study. Patients are assigned to 1 of 3 groups according to risk. After completion of study treatment, patients are followed up every 3-6 months for 3 years and then annually for 10 years.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
RADIATION	54 Gy radiotherapy	External beam radiation therapy (EBRT) to a total dose of 54 Gy (RBE) in 30 fractions. 1.8 Gy (RBE) daily, 5 fractions per week, excluding weekends. 3D-CRT or IMRT or Proton allowed.
RADIATION	60 Gy radiotherapy	External beam radiation therapy using intensity-modulated radiation therapy (IMRT) to a total dose of 60 Gy in 30 fractions. 2.0 Gy daily, 5 fractions per week, excluding weekends.

Timeline

• Start date: 2009-06-01
• Primary completion: 2016-09-01
• Completion: 2023-08-15
• First posted: 2009-05-08
• Last updated: 2023-09-08
• Results posted: 2018-01-19

Locations

78 sites across 2 countries: United States, Canada