Clinical Trial of the Week: New, post-surgical treatment trial for patients diagnosed with grade II meningioma

 By Donna Loyle, communications specialist, LIMR

Researchers are enrolling patients in a brand-new treatment trial of patients who’ve been diagnosed with grade II meningioma and whose tumor has been surgically removed. Researchers seek to determine if radiation therapy (RT) can improve the outcomes in these patients. This is a Phase III clinical study with two treatment arms, which include RT or observation.

Inclusion criteria:

  • Newly diagnosed unifocal intracranial meningioma, gross totally resected, and histologically confirmed as WHO grade II based upon pathology findings.
  • For step 1 registration, the operating neurosurgeon must provide the modified Simpson grade (1-3). GTR must be confirmed on post-op imaging following the most recent surgery; pre- and post-operative MRIs are required for patient (see protocol for specifics if second surgery occurs).
  • Prior to step 2 diagnosis of WHO grade II meningioma confirmed by central pathology review.

See protocol document for complete eligibility requirements, including specific imaging needs.

Treatment:

  • Arm 1: Clinical observation after gross total resection.
  • Arm 2:  Radiation therapy 5 days per week over 6.5 or 7 weeks for a total of 33 treatments.

The principal investigators for trial NRG BN003 are Albert DeNittis, MD, and Paul Gilman, MD. More information is available at https://bit.ly/2NtTdeI

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