Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00075868
First received: January 9, 2004
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Anal Cancer
Colorectal Cancer
Drug/Agent Toxicity by Tissue/Organ
Radiation Enteritis
Drug: octreotide acetate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Prevention of the incidence of moderate, severe, or life-threatening diarrhea

Secondary Outcome Measures:
  • 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

Enrollment: 233
Study Start Date: December 2003
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sandostatin LAR® Depot
Sandostatin LAR® Depot Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)
Drug: octreotide acetate
Placebo Comparator: Placebo
Placebo Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary anal or rectal cancer

    • No metastasis beyond the pelvic regional nodes
  • Must be scheduled to receive chemoradiotherapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Liver function tests < 3 times upper limit of normal
  • No prior hepatic disease

Renal

  • Not specified

Gastrointestinal

  • No prior chronic or acute regional enteritis
  • No malabsorption syndrome
  • No prior inflammatory bowel disease that may exacerbate the radiotherapy toxicity
  • No grade 2 or greater uncontrollable diarrhea at baseline
  • No prior cholecystitis or gallstones, unless a cholecystectomy has been performed
  • No prior incontinence of stool

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No uncontrolled diabetes (e.g., fasting glucose > 250 mg/dL)
  • No prior allergy or hypersensitivity to study drug or other related drug or compound
  • No other medical condition or mental impairment that would preclude study treatment and compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • Prior chemotherapy allowed

Endocrine therapy

  • At least 6 months since prior administration of any of the following:

    • Glucocorticoid therapy
    • Insulin sensitizers (e.g., metformin, pioglitazone, or rosiglitazone)
    • Exogenous growth hormone therapy

Radiotherapy

  • See Disease Characteristics
  • No prior pelvic radiotherapy
  • No prior intensity-modulated radiotherapy
  • No concurrent radiotherapy for abdominal cancer
  • No concurrent hyperfractionated, split-course, or intensity-modulated radiotherapy
  • No brachytherapy prior to or after completion of all external beam radiotherapy

Surgery

  • No prior abdominal-perineal resection or other surgical procedure leaving the patient without a functioning rectum
  • No colostomy

Other

  • More than 30 days since other prior investigational drugs
  • No prior octreotide for cancer therapy-related diarrhea
  • No concurrent prophylactic antidiarrheal medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075868

  Hide Study Locations
Locations
United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
United States, Arizona
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
United States, California
Enloe Cancer Center at Enloe Medical Center
Chico, California, United States, 95926
California Cancer Center - Woodward Park Office
Fresno, California, United States, 93720
Saint Agnes Medical Center
Fresno, California, United States, 93720-3397
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States, 94904
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
Inglewood, California, United States, 90301
Leavey Cancer Center at Northridge Hospital Medical Center
Northridge, California, United States, 91328
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609
Pomona Valley Hospital Medical Center
Pomona, California, United States, 91767
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States, 95815
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Torrance Memorial Medical Center
Torrance, California, United States, 90509
United States, Colorado
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States, 80909
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502
United States, District of Columbia
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
United States, Florida
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States, 33458
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States, 33176
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, United States, 33612
United States, Georgia
John B. Amos Community Cancer Center
Columbus, Georgia, United States, 31904
United States, Illinois
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
United States, Indiana
St. John's Cancer Center at St. John's Medical Center
Anderson, Indiana, United States, 46016
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Veterans Affairs Medical Center - Indianapolis
Indianapolis, Indiana, United States, 46202
Ball Memorial Hospital
Muncie, Indiana, United States, 47303-3499
United States, Iowa
Wendt Regional Cancer Center at Finley Hospital
Dubuque, Iowa, United States, 52001
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503-9985
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0084
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
United States, Michigan
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48909
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Mississippi
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
United States, Nebraska
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, United States, 68114
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
Washoe Cancer Services at Washoe Medical Center - Reno
Reno, Nevada, United States, 89502
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Cancer Institute of New Jersey at Cooper University Hospital - Camden
Camden, New Jersey, United States, 08103
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
Community Regional Cancer Center at Community Medical Center
Toms River, New Jersey, United States, 08755
Fox Chase Cancer Center at St. Francis Medical Center
Trenton, New Jersey, United States, 08629
South Jersey Healthcare Regional Cancer Center
Vineland, New Jersey, United States, 08360
United States, New York
Long Island College Hospital
Brooklyn, New York, United States, 11201
New York Methodist Hospital
Brooklyn, New York, United States, 11215
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
Lipson Cancer and Blood Center at Rochester General Hospital
Rochester, New York, United States, 14621
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Iredell Memorial Hospital
Statesville, North Carolina, United States, 28677
United States, North Dakota
Trinity Cancer Care Center
Minot, North Dakota, United States, 58701
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44309-2090
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States, 44710-1799
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
CCOP - Columbus
Columbus, Ohio, United States, 43215
St. Rita's Medical Center
Lima, Ohio, United States, 45801
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
Salem, Ohio, United States, 44460
Cancer Treatment Center
Wooster, Ohio, United States, 44691
United States, Oklahoma
LaFortune Cancer Center at St. John Medical Center
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Institute of Oncology at Vilnius University
Portland, Oregon, United States, 97227
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
Portland, Oregon, United States, 97210
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Mercy Cancer Institute at Mercy Hospital
Pittsburgh, Pennsylvania, United States, 15219
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224-1791
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Utah
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Washington
St. Joseph Hospital Community Cancer Center
Bellingham, Washington, United States, 98225
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States, 98668
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
United States, Wisconsin
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Columbia St. Mary's Cancer Center
Milwaukee, Wisconsin, United States, 53211
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, United States, 53405
West Allis Memorial Hospital
West Milwaukee, Wisconsin, United States, 53227
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Principal Investigator: Babu Zachariah, MD H. Lee Moffitt Cancer Center and Research Institute
Study Chair: Jaffer A. Ajani, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
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.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00075868     History of Changes
Other Study ID Numbers: RTOG-0315, CDR0000349441
Study First Received: January 9, 2004
Last Updated: August 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Radiation Therapy Oncology Group:
radiation enteritis
drug/agent toxicity by tissue/organ
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
stage IIIA anal cancer
stage IIIB anal cancer
recurrent anal cancer
stage I anal cancer
stage II anal cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Anus Neoplasms
Colorectal Neoplasms
Enteritis
Anus Diseases
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Rectal Neoplasms
Octreotide
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014