Title
Phase III Trial of Observation versus Irradiation for a Gross Totally Resected Grade II Meningioma

Description
Randomized phase III study randomized to observation versus radiation therapy

Objective
The purpose of this study is to compare any good and bad effects of using radiation to treat a meningioma that has been completely removed compared with the more common approach of observing the tumor and treating it with radiation if it returns

Treatment
This study has two study groups


Group 1 will be observed following surgery, without radiation treatment (post-surgery observation)

Group 2 will receive radiation therapy to the area of the brain where the meningioma was removed, with careful attention to minimizing the amount of radiation received by normal tissue

Key Eligibility
Histologically confirmed unifocal intracranial meningioma

No metastatic meningioma

No optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma

No previous radiotherapy to scalp, cranium, brain or skull base, or radiation-induced meningiomas

No prior invasive malignancy unless disease free for a minimum of 3 years

Women of childbearing potential randomized to receive radiation therapy must use medically acceptable forms of contraception, hormonal or non-hormonal, throughout the entire course of radiation therapy

Applicable Disease Sites
Brain/Central Nervous System

Participating Institutions
DN Greenwald Center; Oconomowoc Memorial Hospital, Waukesha Memorial; UW Cancer Center at ProHealth; UW Health Eastpark Medical Center; UW Health University Hospital; Waukesha Memorial Hosp