Sulfasalazine in Preventing Acute Diarrhea in Patients With Cancer Who Are Undergoing Pelvic Radiation Therapy

Summary

RATIONALE: Sulfasalazine may relieve diarrhea in patients with cancer who are undergoing pelvic radiation therapy. PURPOSE: This randomized phase III trial is studying sulfasalazine to see how well it works in preventing acute diarrhea in patients with cancer who are undergoing pelvic radiation therapy.

Timeline

Start

2011-04

Primary completion

2013-07-22

Completion

2017-07-15

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper Final analysis of the primary endpoint showed no significant difference in maximum diarrhea severity between the sulfasalazine and placebo arms (P=.41). PMID 27354129 ↗

registry analysis (unspecified test); Arm I: Sulfasalazine vs Arm II: Placebo; p = 0.41; Wilcoxon (Mann-Whitney) NCT01198145 ↗

Publications

• Miller RC, Petereit DG, Sloan JA, Liu H, Martenson JA, Bearden JD 3rd, Sapiente R, Seeger GR, Mowat RB, Liem B, Iott MJ, Loprinzi CL; Alliance for Clinical Trials in Oncology. N08C9 (Alliance): A Phase 3 Randomized Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy. Int J Radiat Oncol Biol Phys. 2016 Jul 15;95(4):1168-74. doi: 10.1016/j.ijrobp.2016.01.063. Epub 2016 Apr 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sulfasalazine	Small molecule	1000 mg	Oral

Indications