Moffitt logo

Clinical Trials Search

Clinical Trial 20028

Cancer Type: Neurologic Oncology
Interventions:

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Hsiang-Hsuan (Michael) Yu

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

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

Summary

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.

Objective

The primary endpoint is progression-free survival (PFS). The principle objective is to determine the extent of clinical benefit of the addition of adjuvant radiotherapy (RT) to gross total resection (GTR) for patients with newly diagnosed World Health Organization (WHO) grade II meningioma.

Inclusion Criteria

  • PRIOR TO STEP 1 REGISTRATION:
  • The participant 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 resection
  • The participant or a legally authorized representative must provide study-specific informed consent prior to study entry
  • If the participant is a primary English speaker, the participant must participate in the NCF and participant reported outcomes part of the study; if the participant is a primary French or Spanish speaker, the participant must participate in the participant reported outcomes part of the study
  • PRIOR TO STEP 2 REGISTRATION:
  • 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 registration
  • If the participant 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 investigator¿s 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 registration, 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 registration, 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 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 participants 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