Primary and Secondary Endpoint Analysis of N08C9 (Alliance): A Phase 3 Randomized Trial of Sulfasalazine Versus Placebo in the Prevention of Acute Radiation Enteritis

Abstract

At ASTRO 2013, an interim futility analysis that led to the early closure of N08C9 (Alliance), a randomized controlled trial (RCT) comparing sulfasalazine versus placebo in the prevention of radiation enteritis during pelvic RT, was presented. Here, we present the full analysis of the primary endpoint and acute secondary endpoints of the trial.