A Phase II Study of Image-Guided Radiation Therapy for Pediatric CNS Tumors and Quantification of Radiation-Related CNS Effects
Radiation therapy is commonly used to treat a variety of brain tumors in children including
ependymoma, craniopharyngioma and low- and high-grade glioma. The ability of the therapy to
control brain tumors in children is known to depend on the tumor type, extent of resection
and other clinical factors. Children who received radiation therapy on this study were
evaluated for treatment failure at 12 months. In addition to the primary objective, the
study was designed to explore the association between radiation dose and volume and a
variety of neurological, endocrine and cognitive deficits up to 5 years after treatment.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Local Tumor Control
Local tumor control was determined by Magnetic Resonance Imaging (MRI) of the brain and spine performed after radiation therapy. Imaging studies were performed every 3-4 months during the first three years and then every 6 months through five years. Imaging studies demonstrating tumor progression were electronically registered to the imaging data used to plan therapy. Local failure included tumor progression within the volume that received the prescribed dose of irradiation.
12 months after the enrollment of the last therapeutic patient
Thomas E. Merchant, D.O., Ph.D.
St. Jude Children's Research Hospital
United States: Institutional Review Board
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