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  • Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial. Jacksonville, Fla., Rochester, Minn.

    RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma.

    PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic glioma.

  • 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.