NRG-BN003, a Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma
NRG-BN003 is for patients with World Health Organization (WHO) grade II (atypical) meningiomas that have received gross-total resection (GTR). This trial is built upon results from the prior study RTOG-0539, which was one of the first cooperative group trials to successfully accrue and report results, largely because of the buy-in by the neurosurgical oncology community. The results of that study indicated that postoperative RT was a supported treatment option for GTR WHO grade II meningiomas, due to the documented minimal toxicity from IMRT and high rates of tumor control.
NRG-BN003 is a Phase III, prospective randomized trial led by Leland Rogers, MD (Radiation Oncology Chair) and Michael Vogelbaum, MD, PhD, FAANS (Neurosurgery Chair) that aims to accrue 148 patients to determine whether IMRT after GTR of a WHO grade II meningioma improves progression-free survival when compared to observation. GTR (Simpson Grade 1-3) must be confirmed on post-operative imaging following the most recent surgery. In ARM 1, patients undergo observation. In ARM 2, patients undergo radiation therapy five days a week over 6.5-7 weeks for a total of 33 fractions (59.4 Gy in 33 daily fractions of 1.8 Gy each). After completion of the treatment study , patients are followed up at three, six and 12 months, every six months for years two and three, then yearly for 10 years.
Once again, neurosurgeons are the critical drivers of patient enrollment in this trial, through the identification of patients who can meet enrollment criteria. The good news is that the accrual rate is now exceeding (relatively low) expectations and the trial is expected to reach its accrual goal in the next two years. The results of this study are expected to have an impact on what will be considered standard of care for WHO grade II meningiomas.