Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer
This study has been completed.
Sponsor:
Radiation Therapy Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00075868
First received: January 9, 2004
Last updated: September 3, 2010
Last verified: February 2006
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 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 National Cancer Institute (NCI):
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
| Study Start Date: | December 2003 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075868
Hide Study Locations
Hide Study LocationsLocations
| 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 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| Radiological Associates of Sacramento Medical Group, Incorporated | |
| Sacramento, California, United States, 95815 | |
| 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 | |
| Veterans Affairs Medical Center - Indianapolis | |
| Indianapolis, Indiana, United States, 46202 | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| 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 | |
| New York Methodist Hospital | |
| Brooklyn, New York, United States, 11215 | |
| SUNY Downstate Medical Center | |
| Brooklyn, New York, United States, 11203 | |
| Long Island College Hospital | |
| Brooklyn, New York, United States, 11201 | |
| 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 Cancer Center at Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213-2967 | |
| Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center | |
| Portland, Oregon, United States, 97210 | |
| Institute of Oncology at Vilnius University | |
| Portland, Oregon, United States, 97227 | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97225 | |
| Providence St. Vincent Medical Center | |
| 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 | |
| Lankenau Cancer Center at Lankenau Hospital | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| CCOP - MainLine Health | |
| 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 | |
| LDS Hospital | |
| Salt Lake City, Utah, United States, 84143 | |
| Utah Cancer Specialists at UCS Cancer Center | |
| Salt Lake City, Utah, United States, 84106 | |
| 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
| Study Chair: | Babu Zachariah, MD | H. Lee Moffitt Cancer Center and Research Institute |
| Investigator: | 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.
| ClinicalTrials.gov Identifier: | NCT00075868 History of Changes |
| Other Study ID Numbers: | CDR0000349441, RTOG-0315 |
| Study First Received: | January 9, 2004 |
| Last Updated: | September 3, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 Rectal Neoplasms Colorectal Neoplasms Enteritis Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Intestinal Diseases Anus Diseases Rectal Diseases Colonic Diseases Gastroenteritis Octreotide Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 21, 2013