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Protocol No. NRGBN003

Principal Investigator Howard, Steven

Phase III

Age Group Adult

Scope National

Sponsor Type National

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

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

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

  • Description Randomized phase III study randomized to observation versus radiation therapy

    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

    Status Open

    Participating Institutions UW Hospital and Clinics