Clinical Trial 23486

• Overview

  Study Title:

  Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) for Intact Brain Metastases

  Objective:

  Primary Objective To determine if the time to local failure is improved with FSRS compared to SRS in patients with intact (i.e., unresected) brain metastases Secondary Objectives To compare time to intracranial progression-free survival between FSRS and SRS. To compare overall survival between FSRS and SRS. To determine if the time to local failure is improved with FSRS compared to SRS, as evaluated by central review of imaging. To evaluate if there is any difference in CNS failure patterns (local vs. distant brain failure vs. both) in patients who receive FSRS compared to patients who receive SRS. To compare the rates of radiation necrosis in patients who receive FSRS vs. SRS. To compare the time to salvage WBRT between patients who receive FSRS and those who receive SRS. To compare the rates of post-treatment adverse events associated with FSRS and SRS.

• Treatments

  Therapies:

  Radiotherapy

  Medications:

  Radiotherapy (); fSRS ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • 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, or gastrointestinal cancer.
  • 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 => 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 > No more than 2 lesions planned for resection if clinically indicated.
  • No known leptomeningeal disease (LMD).
  • Age >= 18 years.
  • Karnofsky performance status (KPS) >= 60.
  • Not Pregnant and Not Nursing.
  • No prior radiotherapy to the brain (partial or whole brain irradiation, SRS, FSRS, or prophylactic cranial irradiation [PCI]).
  • Other inclusion criteria may apply.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Not meeting all of the inclusion criteria.

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