Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis

Phase 3 Completed 130 enrolled Alliance for Clinical Trials in Oncology National Cancer Institute (NCI) · collab

RandomizedParallel-groupDouble-blindSupportive care

Summary

RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who are undergoing radiation therapy to the pelvis. It is not yet known whether octreotide is effective for diarrhea. PURPOSE: Randomized phase III trial to determine the effectiveness of octreotide in preventing diarrhea in patients who are undergoing radiation therapy to the pelvis.

Timeline

Start: 2002-04
Primary completion: 2006-07
Completion: 2006-07

Outcome

Missed primary endpoint

paper As administered in this study, octreotide did not decrease diarrhea during pelvic radiation therapy. PMID 18768432 ↗

Publications

Results Martenson JA, Halyard MY, Sloan JA, Proulx GM, Miller RC, Deming RL, Dick SJ, Johnson HA, Tai TH, Zhu AW, Keit J, Stien KJ, Atherton PJ. Phase III, double-blind study of depot octreotide versus placebo in the prevention of acute diarrhea in patients receiving pelvic radiation therapy: results of North Central Cancer Treatment Group N00CA. J Clin Oncol. 2008 Nov 10;26(32):5248-53. doi: 10.1200/JCO.2008.17.1546. Epub 2008 Sep 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Octreotide	Peptide	20 mg	Subcutaneous