search
Back to results

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

Primary Purpose

Anal Cancer, Colorectal Cancer, Drug/Agent Toxicity by Tissue/Organ

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
octreotide acetate
Placebo
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anal Cancer focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mobile Infirmary Medical Center
  • Foundation for Cancer Research and Education
  • Enloe Cancer Center at Enloe Medical Center
  • Saint Agnes Medical Center
  • California Cancer Center - Woodward Park Office
  • Sutter Health Western Division Cancer Research Group
  • Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
  • Leavey Cancer Center at Northridge Hospital Medical Center
  • CCOP - Bay Area Tumor Institute
  • Pomona Valley Hospital Medical Center
  • Radiological Associates of Sacramento Medical Group, Incorporated
  • University of California Davis Cancer Center
  • Torrance Memorial Medical Center
  • Memorial Hospital Cancer Center
  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
  • Sibley Memorial Hospital
  • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
  • University of Florida Shands Cancer Center
  • Memorial Cancer Institute at Memorial Regional Hospital
  • Baptist Cancer Institute - Jacksonville
  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
  • CCOP - Mount Sinai Medical Center
  • University of Miami Sylvester Comprehensive Cancer Center
  • Baptist-South Miami Regional Cancer Program
  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
  • Veterans Affairs Medical Center - Tampa (Haley)
  • John B. Amos Community Cancer Center
  • Ingalls Cancer Care Center at Ingalls Memorial Hospital
  • St. John's Cancer Center at St. John's Medical Center
  • Indiana University Cancer Center
  • Veterans Affairs Medical Center - Indianapolis
  • Ball Memorial Hospital
  • Wendt Regional Cancer Center at Finley Hospital
  • Central Baptist Hospital
  • Markey Cancer Center at University of Kentucky Chandler Medical Center
  • Greenebaum Cancer Center at University of Maryland Medical Center
  • Cape Cod Hospital
  • St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
  • CCOP - Michigan Cancer Research Consortium
  • Josephine Ford Cancer Center at Henry Ford Hospital
  • CCOP - Grand Rapids
  • West Michigan Cancer Center
  • Sparrow Regional Cancer Center
  • William Beaumont Hospital - Royal Oak Campus
  • Mayo Clinic Cancer Center
  • Regional Cancer Center at Singing River Hospital
  • CCOP - Kansas City
  • CCOP - Cancer Research for the Ozarks
  • St. John's Regional Health Center
  • Siteman Cancer Center at Barnes-Jewish Hospital
  • Methodist Cancer Center at Methodist Hospital - Omaha
  • University Medical Center of Southern Nevada
  • CCOP - Nevada Cancer Research Foundation
  • Washoe Cancer Services at Washoe Medical Center - Reno
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • Cancer Institute of New Jersey at Cooper University Hospital - Camden
  • Monmouth Medical Center
  • Community Regional Cancer Center at Community Medical Center
  • Fox Chase Cancer Center at St. Francis Medical Center
  • South Jersey Healthcare Regional Cancer Center
  • Long Island College Hospital
  • SUNY Downstate Medical Center
  • New York Methodist Hospital
  • Roswell Park Cancer Institute
  • CCOP - North Shore University Hospital
  • Lipson Cancer and Blood Center at Rochester General Hospital
  • Duke Comprehensive Cancer Center
  • Iredell Memorial Hospital
  • Trinity Cancer Care Center
  • Akron City Hospital
  • Aultman Hospital Cancer Center at Aultman Health Foundation
  • Cleveland Clinic Taussig Cancer Center
  • CCOP - Columbus
  • St. Rita's Medical Center
  • Hillcrest Cancer Center at Hillcrest Hospital
  • Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
  • Cancer Treatment Center
  • LaFortune Cancer Center at St. John Medical Center
  • Legacy Mount Hood Medical Center
  • Providence Milwaukie Hospital
  • Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
  • Providence Cancer Center at Providence Portland Medical Center
  • CCOP - Columbia River Oncology Program
  • Providence St. Vincent Medical Center
  • Institute of Oncology at Vilnius University
  • Legacy Meridian Park Hospital
  • Bryn Mawr Hospital
  • Delaware County Regional Cancer Center at Delaware County Memorial Hospital
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • Paoli Memorial Hospital
  • Allegheny Cancer Center at Allegheny General Hospital
  • Mercy Cancer Institute at Mercy Hospital
  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
  • Reading Hospital and Medical Center
  • CCOP - MainLine Health
  • Lankenau Cancer Center at Lankenau Hospital
  • CCOP - Greenville
  • CCOP - Upstate Carolina
  • CCOP - Scott and White Hospital
  • McKay-Dee Hospital Center
  • Utah Valley Regional Medical Center - Provo
  • Dixie Regional Medical Center - East Campus
  • Utah Cancer Specialists at UCS Cancer Center
  • LDS Hospital
  • St. Joseph Hospital Community Cancer Center
  • Southwest Washington Medical Center Cancer Center
  • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
  • St. Vincent Hospital Regional Cancer Center
  • Columbia St. Mary's Cancer Center
  • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
  • All Saints Cancer Center at All Saints Healthcare
  • West Allis Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sandostatin LAR® Depot

Placebo

Arm Description

Sandostatin LAR® Depot Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)

Placebo Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)

Outcomes

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

Full Information

First Posted
January 9, 2004
Last Updated
November 14, 2015
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00075868
Brief Title
Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Cancer, Colorectal Cancer, Drug/Agent Toxicity by Tissue/Organ, Radiation Enteritis
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
233 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sandostatin LAR® Depot
Arm Type
Experimental
Arm Description
Sandostatin LAR® Depot Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)
Intervention Type
Drug
Intervention Name(s)
octreotide acetate
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Prevention of the incidence of moderate, severe, or life-threatening diarrhea
Secondary Outcome Measure Information:
Title
Quality of life
Title
Economic measures
Title
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
Title
Prevention of the incidence of severe or life-threatening (i.e., grade 3-5) diarrhea

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
20339140
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs