NRG-BN013

Clinical Trial Title Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) for Intact Brain Metastases
Trial Status Open to Enrollment
Start Date 10/17/2025
Location hospitals
Trial Type Cancer - Adult Oncology
Specific Condition Brain Tumor
Description This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of radiation to the tumor over 3 treatments. SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain.
Eligibility Criteria

Eligibility Criteria

  • Documentation of Disease
    Pathologically (histologically or cytologically) proven diagnosis of one of the following solid tumor malignancies within 5 years prior to registration:
    • non-small cell lung cancer
    • melanoma
    • breast cancer
    • renal cell carcinoma
    • gastrointestinal cancer
    If the original histologic proof of malignancy is greater than 5 years, then more recent pathologic confirmation (e.g., from a systemic site or brain metastasis) or unequivocal imaging confirmation of extracranial metastatic disease (e.g. CT of the chest/abdomen/pelvis, PET/CT, etc.) is required.
  • Patients must have at least 1 and up to 8 total intact brain metastases detected on a contrast-enhanced MRI (see Appendix I for imaging guidelines) performed ≤ 21 days prior to registration.
  • At least 1 of the up to 8 lesions must be a study eligible lesion, defined as lesion with a maximum diameter as measured on any orthogonal plane (axial, sagittal, coronal) of ≥ 1.0 cm and ≤ 3.0 cm.
  • All brain metastases must be located outside of the brainstem and ≥5 mm from the optic nerves or optic chiasm and ≤ 3.0 cm in maximum dimension.
  • Patients must have a diagnosis-specific graded prognostic assessment ≥1.5
  • No known leptomeningeal disease (LMD)
  • Karnofsky performance status (KPS) ≥ 60
  • No prior radiotherapy to the brain 

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.
IRB Number Central IRB
Notes Study Details | NCT06500455 | Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain | ClinicalTrials.gov
Principal Investigator Andrew Kee, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org