Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer
A Randomized, Double Blind, Placebo-Controlled Phase III Study To Determine The Efficacy Of Sandostatin LAR® Depot (Octreotide Acetate) In Preventing Or Reducing The Severity Of Chemoradiation-Induced Diarrhea In Patients With Anal Or Rectal Cancer
2 other identifiers
interventional
233
1 country
112
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
112 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 9, 2004
CompletedFirst Posted
Study publicly available on registry
January 13, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedNovember 17, 2015
November 1, 2015
2.7 years
January 9, 2004
November 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevention of the incidence of moderate, severe, or life-threatening diarrhea
Secondary Outcomes (4)
Quality of life
Economic measures
Validity of the Functional Alterations due to Changes in Elimination-Changes in Bowel Function, the Quality of Life-Radiation Therapy Instrument, and the Expand Prostate Index Composite-Bowel questionnaires
Prevention of the incidence of severe or life-threatening (i.e., grade 3-5) diarrhea
Study Arms (2)
Sandostatin LAR® Depot
EXPERIMENTALSandostatin LAR® Depot Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)
Placebo
PLACEBO COMPARATORPlacebo Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Radiation Therapy Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (112)
Mobile Infirmary Medical Center
Mobile, Alabama, 36652-2144, United States
Foundation for Cancer Research and Education
Phoenix, Arizona, 85013, United States
Enloe Cancer Center at Enloe Medical Center
Chico, California, 95926, United States
Saint Agnes Medical Center
Fresno, California, 93720-3397, United States
California Cancer Center - Woodward Park Office
Fresno, California, 93720, United States
Sutter Health Western Division Cancer Research Group
Greenbrae, California, 94904, United States
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
Inglewood, California, 90301, United States
Leavey Cancer Center at Northridge Hospital Medical Center
Northridge, California, 91328, United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609, United States
Pomona Valley Hospital Medical Center
Pomona, California, 91767, United States
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, 95815, United States
University of California Davis Cancer Center
Sacramento, California, 95817, United States
Torrance Memorial Medical Center
Torrance, California, 90509, United States
Memorial Hospital Cancer Center
Colorado Springs, Colorado, 80909, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, 81502, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
University of Florida Shands Cancer Center
Gainesville, Florida, 32610-0232, United States
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, 33021, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, 32207, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, 33458, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Baptist-South Miami Regional Cancer Program
Miami, Florida, 33176, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, 33612-9497, United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, 33612, United States
John B. Amos Community Cancer Center
Columbus, Georgia, 31904, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
St. John's Cancer Center at St. John's Medical Center
Anderson, Indiana, 46016, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289, United States
Veterans Affairs Medical Center - Indianapolis
Indianapolis, Indiana, 46202, United States
Ball Memorial Hospital
Muncie, Indiana, 47303-3499, United States
Wendt Regional Cancer Center at Finley Hospital
Dubuque, Iowa, 52001, United States
Central Baptist Hospital
Lexington, Kentucky, 40503-9985, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536-0084, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Cape Cod Hospital
Hyannis, Massachusetts, 02601, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731, United States
Sparrow Regional Cancer Center
Lansing, Michigan, 48909, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, 48073, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, 39581, United States
CCOP - Kansas City
Kansas City, Missouri, 64131, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65802, United States
St. John's Regional Health Center
Springfield, Missouri, 65804, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, 68114, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Washoe Cancer Services at Washoe Medical Center - Reno
Reno, Nevada, 89502, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0002, United States
Cancer Institute of New Jersey at Cooper University Hospital - Camden
Camden, New Jersey, 08103, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740-6395, United States
Community Regional Cancer Center at Community Medical Center
Toms River, New Jersey, 08755, United States
Fox Chase Cancer Center at St. Francis Medical Center
Trenton, New Jersey, 08629, United States
South Jersey Healthcare Regional Cancer Center
Vineland, New Jersey, 08360, United States
Long Island College Hospital
Brooklyn, New York, 11201, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
New York Methodist Hospital
Brooklyn, New York, 11215, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001, United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030, United States
Lipson Cancer and Blood Center at Rochester General Hospital
Rochester, New York, 14621, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710, United States
Iredell Memorial Hospital
Statesville, North Carolina, 28677, United States
Trinity Cancer Care Center
Minot, North Dakota, 58701, United States
Akron City Hospital
Akron, Ohio, 44309-2090, United States
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, 44710-1799, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
CCOP - Columbus
Columbus, Ohio, 43215, United States
St. Rita's Medical Center
Lima, Ohio, 45801, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, 44124, United States
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
Salem, Ohio, 44460, United States
Cancer Treatment Center
Wooster, Ohio, 44691, United States
LaFortune Cancer Center at St. John Medical Center
Tulsa, Oklahoma, 74104, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, 97222, United States
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
Portland, Oregon, 97210, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213-2967, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Institute of Oncology at Vilnius University
Portland, Oregon, 97227, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, 97062, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792, United States
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Mercy Cancer Institute at Mercy Hospital
Pittsburgh, Pennsylvania, 15219, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224-1791, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
CCOP - Greenville
Greenville, South Carolina, 29615, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303, United States
CCOP - Scott and White Hospital
Temple, Texas, 76508, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84604, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, 84106, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Dixie Regional Medical Center - East Campus
St. George, Utah, 84770, United States
St. Joseph Hospital Community Cancer Center
Bellingham, Washington, 98225, United States
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, 98668, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, 98902, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508, United States
Columbia St. Mary's Cancer Center
Milwaukee, Wisconsin, 53211, United States
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, 53405, United States
West Allis Memorial Hospital
West Milwaukee, Wisconsin, 53227, United States
Related Publications (2)
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.
PMID: 20339140RESULTZachariah 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.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Babu Zachariah, MD
H. Lee Moffitt Cancer Center and Research Institute
- STUDY CHAIR
Jaffer A. Ajani, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2004
First Posted
January 13, 2004
Study Start
December 1, 2003
Primary Completion
August 1, 2006
Last Updated
November 17, 2015
Record last verified: 2015-11