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

Brain and Central Nervous System Tumors Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Meningioma
• Nervous System Neoplasms

• NCT number: NCT00895622
• Study type: Interventional
• Source: Radiation Therapy Oncology Group
• Status: Completed
• Phase: Phase 2
• Start date: June 2009
• Completion date: August 15, 2023