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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

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

  • 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