Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery

Not Recruiting

Trial ID: NCT03180268


This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.

Official Title

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

Stanford Investigator(s)

Scott G. Soltys, MD
Scott G. Soltys, MD

Professor of Radiation Oncology (Radiation Therapy) and, by courtesy, of Neurosurgery


Inclusion Criteria:


   - The patient must have a newly diagnosed unifocal intracranial meningioma, gross
   totally resected, and histologically confirmed as WHO grade II based upon pathology
   findings at the enrolling institution; WHO grade will be assigned according to WHO
   2016 criteria

   - Gross total resection (GTR) will be interpreted as modified Simpson grade 1-3 without
   gross residual dural-based or extradural tumor; GTR must be confirmed both by modified
   Simpson grade and by post-operative magnetic resonance imaging (MRI) findings

   - Step 1 registration must occur within 180 days of the initial surgery; within this 180
   day interval, a second surgery is permitted in order to achieve GTR, but even with a
   second surgery, step 1 registration must occur within 180 days of the initial

   - For step 1 registration the operating neurosurgeon must provide the modified Simpson

   - GTR must be confirmed on post-operative imaging following the most recent surgery;
   submission of both pre-operative and post-operative MRIs is required for patients; if
   a second surgery is performed, submission of post-operative MRI is required and
   pre-operative MRI is required only if obtained; all sequences obtained in the pre- and
   post-operative MR imaging are to be submitted to National Radiology Group (NRG)
   Oncology for study registration; imaging subsequent to enrollment must include pre and
   post gadolinium contrast-enhanced three-dimensional spoiled gradient (SPGR),
   magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI
   scan and an axial T2 fluid attenuated inversion recovery (FLAIR) sequence; to yield
   acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR,
   MP-RAGE, or TFE axial MRI scan should use the smallest possible axial slice thickness
   not exceeding 1.5 mm; the post-operative MRI must be completed within sufficient time
   to permit step 1 registration within 180 days of the initial resection; these same
   conditions apply in the setting of a second surgical procedure, although if a second
   surgery is completed, step 1 registration must still occur with 180 days of initial
   surgery; computed tomography (CT) imaging is not required, but may be obtained if
   desired clinically, for instance to assess calcifications or hyperostosis

   - The patient or a legally authorized representative must provide study-specific
   informed consent prior to study entry

   - If the patient is a primary English speaker, the patient must participate in the NCF
   and patient reported outcomes part of the study; if the patient is a primary French or
   Spanish speaker, the patient must participate in the patient reported outcomes part of
   the study

   - NOTE: Central pathology review must occur between steps 1 and 2 of registration; once
   appropriate pathology specimens are received, central pathology review will occur
   within 15 days, and must confirm WHO grade II meningioma before the patient can
   proceed to step 2 registration and randomization


   - Histologically confirmed diagnosis of WHO grade II meningioma confirmed by central
   pathology review prior to step 2 registration

   - History/physical examination, including neurologic examination within 60 days prior to
   step 2 registration

   - Post-operative Zubrod performance status 0-1 within 60 days prior to step 2

   - If the patient is a woman is of childbearing potential, a serum pregnancy test,
   obtained within 14 days prior to step 2 registration, must be negative, and, if
   randomized to receive radiation therapy, the woman must agree to use contraception

Exclusion Criteria:

   - Optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple
   meningiomas, hemangiopericytoma

   - Definitive evidence of metastatic meningioma

   - Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
   for a minimum of 3 years (carcinoma in situ of the breast, oral cavity, cervix,
   melanoma in situ, or other non-invasive malignancies are permissible)

   - Previous radiotherapy to the scalp, cranium, brain, or skull base and
   radiation-induced meningiomas

   - Major medical illnesses or psychiatric impairments, which in the investigators
   opinion, will prevent administration or completion of the protocol therapy and/or
   preclude informed consent; these include, but are not restricted to:

      - Unstable angina and/or congestive heart failure requiring hospitalization at the
      time of step 2 registration

      - Transmural myocardial infarction within the last 6 months prior to step 2

      - Acute bacterial or fungal infection requiring intravenous antibiotics at the time
      of step 2 registration

      - Chronic obstructive pulmonary disease exacerbation or other respiratory illness
      requiring hospitalization or precluding study therapy at the time of step 2

      - Type II neurofibromatosis (NF2)

      - Ailments entailing substantial increases in sensitivity and side effect risk from
      radiation therapy (ataxia telangiectasia, Nijmegen breakage syndrome, and human
      immunodeficiency virus (HIV) with CD4 count < 200 cells/microliter); HIV testing
      is not required for eligibility for this protocol, and known HIV positive
      patients are eligible, provided they are under treatment with highly active
      antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter
      within 30 days prior to step 2 registration

      - Inability to undergo MRI with and without contrast (e.g. claustrophobia, non-MRI
      compatible implant or foreign body, etc) or receive gadolinium; note that
      patients with severe claustrophobia are permitted on this study if they are
      willing and able to undergo MRI with adequate sedation or anesthesia

   - Pregnancy and/or nursing females


other: Clinical Observation

radiation: Radiation Therapy

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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