The goal of this Phase III study is to evaluate in a multi-centered, randomized trial whether sodium thiosulfate or STS is an effective and safe means of preventing hearing loss in children receiving cisplatin chemotherapy for newly diagnosed germ cell, liver, brain , nerve tissue or bone cancers. Eligible children will be 1 to 18 years of age who are scheduled to receive cisplatin according to their disease-specific regimen and, upon enrollment onto this study, will be randomized to receive STS or placebo.
Efficacy of STS will be determined through comparison of hearing sensitivity at follow-up relative to baseline measurements using standard audiometric techniques. The trial is expected to enroll up to 120 patients over approximately three years in up to 230 COG centers in the United States, Canada, Australia and Europe.
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