Originally published as JCO Early Release 10.1200/JCO.2008.17.1546 on September 2 2008

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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

James A. Martenson, Michele Y. Halyard, Jeff A. Sloan, Gary M. Proulx, Robert C. Miller, Richard L. Deming, Stephen J. Dick, Harold A. Johnson, T.H. Patricia Tai, Angela W. Zhu, Joan Keit, Kathy J. Stien, Pamela J. Atherton

From the Department of Radiation Oncology, and the Division of Biostatistics, Mayo Clinic, Rochester, MN; the Department of Radiation Oncology, Mayo Clinic, Scottsdale, AZ; the Department of Radiation Oncology, Guthrie Health/Robert Packer Hospital, Sayre, PA; the Iowa Oncology Research Association CCOP, Des Moines; the Siouxland Hematology-Oncology Associates, Sioux City, IA; the Toledo Community Hospital Oncology Program, Toledo, OH; the Allan Blair Cancer Center, Regina, Saskatchewan, Canada; the Wichita Community Clinical Oncology Program, Wichita, KS; and the Missouri Valley Cancer Consortium, Omaha, NE

Corresponding author: James A. Martenson, MD, Department of Radiation Oncology, Mayo Clinic, 200 First St SW, Rochester, MN 55905; e-mail: jmartenson{at}mayo.edu

Purpose To assess the effectiveness of depot octreotide for the prevention of diarrhea during pelvic radiation therapy.

Patients and Methods Patients receiving pelvic radiation therapy (planned minimum dose, 45 Gy; 1.7 to 2.1 Gy daily) were eligible for the study. From May 10, 2002, through October 14, 2005, 125 patients were randomly allocated in a double-blind fashion to receive octreotide (100 µg, administered subcutaneously on day 1, followed by depot octreotide, 20 mg, administered intramuscularly on days 2 and 29; n = 62) or to receive a placebo (n = 63).

Results Grade 0, 1, 2, and 3 diarrhea were observed in 18%, 31%, 31%, and 21% of patients in the octreotide arm, respectively, and in 25%, 32%, 22%, and 21% of patients in the placebo arm, respectively (P = .64). Grade 0, 1, 2, and 3 abdominal cramps were observed in 32%, 45%, 21%, and 2% of patients receiving octreotide, respectively, and in 51%, 24%, 21%, and 5% of patients receiving the placebo, respectively (P = .053). Some patient-reported symptoms were worse in the octreotide group, including nocturnal bowel movements (70% v 45%; P = .004), clustering of bowel movements (90% v 69%; P = .004), and bleeding with bowel movements (57% v 35%; P = .01).

Conclusion As administered in this study, octreotide did not decrease diarrhea during pelvic radiation therapy. Some gastrointestinal symptoms were worse in patients treated with octreotide. Octreotide is not indicated for prevention of diarrhea during pelvic radiation therapy.

published online ahead of print at www.jco.org on September 2, 2008.

This study was conducted as a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic and was supported in part by Public Health Service Grants No. CA-60276, CA-35101, CA-35103, CA-35415, CA-35431, CA-63849, CA-35269, CA-35119, CA-37417, CA-35267, CA-52654, and CA-35195. Supplementary funding and medications were provided by Novartis (Basel, Switzerland). This clinical trial was conducted by the NCCTG, which is funded by the National Cancer Institute. Supplementary funding and the medication used in this study were provided by Novartis (Basel, Switzerland). The NCCTG retained sole responsibility for data collection, analysis, and interpretation. Novartis did not have a role in the authorship of this manuscript, except for an opportunity to comment on its content before submission for publication.

Presented in part in abstract format at the 42nd Annual Meeting of the American Society of Clinical Oncology, Atlanta, GA, June 2-6, 2006.

This study has been registered at http://clinicaltrials.gov/ under the following identifier: NCT00033605 [ClinicalTrials.gov] .

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00033605 [ClinicalTrials.gov] .

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