Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer
- Conditions
- Anal CancerColorectal CancerDrug/Agent Toxicity by Tissue/OrganRadiation Enteritis
- Interventions
- Other: Placebo
- Registration Number
- NCT00075868
- Lead Sponsor
- Radiation Therapy Oncology Group
- 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.
- Detailed Description
OBJECTIVES:
Primary
* Determine the ability of octreotide to prevent the incidence of moderate, severe, or life-threatening chemoradiotherapy-induced diarrhea (grades 2-4) in patients with anal or rectal cancer.
Secondary
* Compare the quality of life of patients treated with this drug vs placebo.
* Compare the number of hospitalizations and use of antidiarrheal agents (e.g., Imodium®) related to diarrhea (or its complications) in patients treated with these drugs.
* Compare treatment delays and/or dose reductions (chemotherapy and radiotherapy) in patients treated with these drugs.
OUTLINE: This is a double-blind, placebo-controlled, randomized, multicenter study. Patients are stratified according to radiotherapy dose (\< 50 Gy vs ≥ 50 Gy), chemotherapy dose (bolus vs continuous), and gender. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive octreotide\* intramuscularly (IM) 4-7 days before the start of chemoradiotherapy and on day 22 (± 3 days) during chemoradiotherapy.
* Arm II: Patients receive placebo\* IM 4-7 days before the start of chemoradiotherapy and on day 22 (± 3 days) during chemoradiotherapy.
NOTE: \*Patients receive a total of 2 injections of octreotide or placebo
In both arms, treatment continues in the absence of unacceptable toxicity.
Quality of life is assessed at baseline, at the completion of chemoradiotherapy, and at 3, 6, 9, and 15 months from the start of chemoradiotherapy.
Patients are followed at 3, 6, 9, and 15 months from the start of chemoradiotherapy.
PROJECTED ACCRUAL: A total of 226 patients (113 per treatment arm) will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 233
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sandostatin LAR® Depot octreotide acetate Sandostatin LAR® Depot Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days) Placebo Placebo Placebo Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)
- Primary Outcome Measures
Name Time Method Prevention of the incidence of moderate, severe, or life-threatening diarrhea
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (112)
Mercy Cancer Institute at Mercy Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Allegheny Cancer Center at Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Baptist-South Miami Regional Cancer Program
🇺🇸Miami, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Veterans Affairs Medical Center - Indianapolis
🇺🇸Indianapolis, Indiana, United States
Utah Cancer Specialists at UCS Cancer Center
🇺🇸Salt Lake City, Utah, United States
Foundation for Cancer Research and Education
🇺🇸Phoenix, Arizona, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Saint Agnes Medical Center
🇺🇸Fresno, California, United States
California Cancer Center - Woodward Park Office
🇺🇸Fresno, California, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Cape Cod Hospital
🇺🇸Hyannis, Massachusetts, United States
Memorial Hospital Cancer Center
🇺🇸Colorado Springs, Colorado, United States
Sibley Memorial Hospital
🇺🇸Washington, District of Columbia, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Regional Cancer Center at Singing River Hospital
🇺🇸Pascagoula, Mississippi, United States
CCOP - Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸St Louis, Missouri, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Cancer Institute of New Jersey at Cooper University Hospital - Camden
🇺🇸Camden, New Jersey, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Fox Chase Cancer Center at St. Francis Medical Center
🇺🇸Trenton, New Jersey, United States
South Jersey Healthcare Regional Cancer Center
🇺🇸Vineland, New Jersey, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
Iredell Memorial Hospital
🇺🇸Statesville, North Carolina, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Providence Milwaukie Hospital
🇺🇸Milwaukie, Oregon, United States
Legacy Meridian Park Hospital
🇺🇸Tualatin, Oregon, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
Dixie Regional Medical Center - East Campus
🇺🇸Saint George, Utah, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Southwest Washington Medical Center Cancer Center
🇺🇸Vancouver, Washington, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
🇺🇸Yakima, Washington, United States
All Saints Cancer Center at All Saints Healthcare
🇺🇸Racine, Wisconsin, United States
West Allis Memorial Hospital
🇺🇸West Milwaukee, Wisconsin, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
🇺🇸Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Institute of Oncology at Vilnius University
🇺🇸Portland, Oregon, United States
Methodist Cancer Center at Methodist Hospital - Omaha
🇺🇸Omaha, Nebraska, United States
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Columbia St. Mary's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
William Beaumont Hospital - Royal Oak Campus
🇺🇸Royal Oak, Michigan, United States
Enloe Cancer Center at Enloe Medical Center
🇺🇸Chico, California, United States
Leavey Cancer Center at Northridge Hospital Medical Center
🇺🇸Northridge, California, United States
Sutter Health Western Division Cancer Research Group
🇺🇸Greenbrae, California, United States
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
🇺🇸Inglewood, California, United States
Pomona Valley Hospital Medical Center
🇺🇸Pomona, California, United States
Torrance Memorial Medical Center
🇺🇸Torrance, California, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
🇺🇸Grand Junction, Colorado, United States
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
Memorial Cancer Institute at Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
St. John's Cancer Center at St. John's Medical Center
🇺🇸Anderson, Indiana, United States
Ball Memorial Hospital
🇺🇸Muncie, Indiana, United States
Wendt Regional Cancer Center at Finley Hospital
🇺🇸Dubuque, Iowa, United States
Lankenau Cancer Center at Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States
John B. Amos Community Cancer Center
🇺🇸Columbus, Georgia, United States
Baptist Cancer Institute - Jacksonville
🇺🇸Jacksonville, Florida, United States
Washoe Cancer Services at Washoe Medical Center - Reno
🇺🇸Reno, Nevada, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
🇺🇸Jupiter, Florida, United States
Community Regional Cancer Center at Community Medical Center
🇺🇸Toms River, New Jersey, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Long Island College Hospital
🇺🇸Brooklyn, New York, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Trinity Cancer Care Center
🇺🇸Minot, North Dakota, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
Aultman Hospital Cancer Center at Aultman Health Foundation
🇺🇸Canton, Ohio, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Hillcrest Cancer Center at Hillcrest Hospital
🇺🇸Mayfield Heights, Ohio, United States
Akron City Hospital
🇺🇸Akron, Ohio, United States
St. Rita's Medical Center
🇺🇸Lima, Ohio, United States
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
🇺🇸Salem, Ohio, United States
Cancer Treatment Center
🇺🇸Wooster, Ohio, United States
Legacy Mount Hood Medical Center
🇺🇸Gresham, Oregon, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
🇺🇸Drexel Hill, Pennsylvania, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
St. Joseph Hospital Community Cancer Center
🇺🇸Bellingham, Washington, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
LaFortune Cancer Center at St. John Medical Center
🇺🇸Tulsa, Oklahoma, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Radiological Associates of Sacramento Medical Group, Incorporated
🇺🇸Sacramento, California, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
🇺🇸Tampa, Florida, United States
Veterans Affairs Medical Center - Tampa (Haley)
🇺🇸Tampa, Florida, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
Lipson Cancer and Blood Center at Rochester General Hospital
🇺🇸Rochester, New York, United States
Paoli Memorial Hospital
🇺🇸Paoli, Pennsylvania, United States