NRG-BN009: Phase III Trial of Salvage Stereotactic Radiosurgery (SRS) or SRS + Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for First or Second Distant Brain Relapse After Upfront SRS with Brain Metastasis Velocity >/= 4 Brain Metastases/Year

About this Study

This phase III trial compares the effect of adding whole brain radiotherapy with hippocampal avoidance and memantine to stereotactic radiosurgery versus stereotactic radiosurgery alone in treating patients with cancer that has spread to the brain and come back in other areas of the brain after earlier stereotactic radiosurgery.

Sponsor Protocol ID:NRG-BN009
IRB Number:2021-0613
Actively Enrolling
Phase 3
July 12, 2022
Eligibility Criteria
18 years old
Both Male and Female

Inclusion Criteria
  • Must have developed first or second distant brain relapse(s) at least 8 weeks after upfront stereotactic radiosurgery (SRS) and within 12 days prior to randomization
  • Pathologically proven diagnosis of non-small cell lung cancer, melanoma, breast cancer, renal cell carcinoma
  • Able to care for self
  • Negative urine or serum pregnancy test

Exclusion Criteria
  • Prior whole brain radiation therapy or prophylactic cranial irradiation
  • Local relapse of metastasis previously treated with upfront stereotactic radiosurgery (SRS)
  • Brain metastases from primary germ cell tumor, small cell carcinoma or lymphoma
  • Leptomeningeal metastasis
  • Unable to swallow pills
  • Known history of demyelinating disease such as multiple sclerosis
  • Planned cytotoxic chemotherapy on the same day as SRS or HA-WBRT
  • Contraindications to memantine
  • Severe, active co-morbidity defined as:                                                       unstable angina, congestive heart failure, myocardial infarction, etc.
  • Pregnant or breast feeding

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Participating Locations
Cancer Center and Research Institute - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Jennifer Barnes
Phone Number: 601-815-4540
Principal Investigator:Mark Anderson
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