May 13 2020
There is currently an urgent need to determine if adjuvant therapy following a gross total resection (GTR) is beneficial to patients with newly diagnosed World Health Organization (WHO) classified Grade II meningioma. Researchers have not determined a best practice in this specific setting, however the improved, modern WHO 2007 and 2016 standards for grading meningiomas have contributed to the growth of WHO Grade II meningioma cases from 5% in previous years to approximately 20-35% in recent years (Claus 2005, Perry 2006, Pearson 2008, Rogers 2010).
NRG Oncology initiated the Phase III trial NRG-BN003 to examine if radiotherapy following GTR of a WHO Grade II meningioma improves progression-free survival (PFS) outcomes for patients compared to observation alone. This trial is active and currently recruiting patients with the goal of accruing approximately 147 participants. Patients with a newly diagnosed gross totally resected WHO Grade II mengingoma will be registered and then randomly assigned to either observation or standard fractionation radiation therapy (RT) 5 days a week over 6.5 to 7 weeks to a final dose of 5940 cGy in 33 fractions. The trial categorizes GTR as Simpson Grades 1-3. Multiple analyses have found improved outcomes with Simpson grades 1 -2 or 1-3 resection, and Simpson grades 1-3 correspond well to gross total resection as judged with post-operative MRI.This definition has been shown to have prognostic value (Hasseleid 2012, Heald 2014, Jenkinson 2016) and has been previously adopted by the EORTC (EORTC 22042-26042) as well as NRG (NRG Oncology/RTOG 0539) trials. Patients with gross residual extradural tumor are ineligible for the NRG-BN003 trial.
“WHO grading classifications have greatly improved since their inception in 1993, however there has yet to be an agreement on a single, best practice in the treatment of WHO Grade II meningioma as these classifications have modernized. NRG-BN003 was designed in an effort to determine what, if any, benefit can be derived from adding adjuvant radiotherapy to gross total resection surgery in an effort to establish which treatment option should be standard of care,” stated C. Leland Rogers, MD, of the Barrow Neurological Institute and Principal Investigator of NRG-BN003.
Other secondary objectives that NRG-BN003 will determine include: the rate of overall survival and disease-specific survival, grade 3 or greater toxicity measurements, outcome and patient-reported outcome measurements, the adherence to protocol-specific target and normal tissue parameters, the concordance between central versus patient-institution pathology, and the assessment of pHH3 mitotic index and its correlation with PFS and overall survival. Tissue and specimens will also be collected on this trial for future translational research.
NRG-BN003 on Clinicaltrials.gov
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