Preliminary Results of a Phase I/II Study of Sodium Pentosanpolysulfate in the Treatment of Chronic Radiation-Induced Proctitis

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Abstract
This is a report of a phase I/II study of 13 patients treated with sodium pentosanpolysulfate (PPS) for chronic radiation- induced proctitis. A complete response was obtained in 82%, a partial response occurred in 9%, and 9% failed to respond to therapy. No significant toxicity was observed. It is concluded that PPS is an effective treatment for chronic radiation- induced proctitis and a phase III randomized, double-blind study of PPS versus placebo is planned.