Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer

Phase 3 Completed 233 enrolled Radiation Therapy Oncology Group 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 chemoradiotherapy for anal or rectal cancer. It is not yet known whether octreotide is effective in treating diarrhea. PURPOSE: This randomized phase III trial is studying octreotide in preventing or reducing diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer.

Timeline

Start: 2003-12
Primary completion: 2006-08
Completion: —

Outcome

Missed primary endpoint

paper incidence rates of grades 2-4 acute diarrhea were similar in both groups (49% placebo vs 44% LAO; P = .21). PMID 20339140 ↗

Publications

Results Zachariah B, Gwede CK, James J, Ajani J, Chin LJ, Donath D, Rosenthal SA, Kane BL, Rotman M, Berk L, Kachnic LA. Octreotide acetate in prevention of chemoradiation-induced diarrhea in anorectal cancer: randomized RTOG trial 0315. J Natl Cancer Inst. 2010 Apr 21;102(8):547-56. doi: 10.1093/jnci/djq063. Epub 2010 Mar 25.
Results Zachariah B, James J, Gwede CK, et al.: RTOG 0315: a randomized, double-blind, placebo-controlled phase III study to determine the efficacy of octreotide acetate in preventing or reducing the severity of chemoradiation-induced diarrhea in patients with anal or rectal cancer. [Abstract] J Clin Oncol 25 (Suppl 18): A-4032, 2007.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Octreotide	Peptide	30 mg	Intramuscular