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  • A071801, Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS for Resected Metastatic Brain Disease (SRS FSRS) Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to compare how well single fraction stereotactic radiosurgery works versus fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body and has been removed by surgery. Single fraction stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Fractionated stereotactic radiosurgery delivers multiple, smaller doses of radiation therapy over time.

  • Protocol Title: Phase IIR Trial of Single Fraction Stereotactic Radiosurgery (SRS) Compared with Fractionated SRS (FSRS) for Intact Metastatic Brain Disease (FRACTIONATE) (GMROR2163) Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

    All lesions 4.0 cm to 6.0 cm will receive 32.5 Gy/5 fractions and will be analyzed separately.  The portion of the trial is written as a phase II study without randomization noting the rarity of unresected brain metastasis of this size and the lack of comfort of treating radiation oncologist and neurosurgeons with single fraction SRS for tumors this large. However, noting the paucity of prospective data for this patient population enrolling patients on a clinical trial will provide a more accurate historical control for future trials.  Although this cohort was enrolled on the prospective phase I trial from Emory and the fractionation of 32.5 Gy in 5 fraction appeared safe and efficacious, a larger cohort of patients is needed to better evaluate the therapeutic ratio of this regimen for this patient population.