Pentosan Polysulfate in Treating Patients With Gastrointestinal Disturbance Caused by Radiation Therapy
- Conditions
- Radiation EnteritisDiarrhea
- Registration Number
- NCT00003825
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
RATIONALE: Pentosan polysulfate may be effective in treating side effects of radiation therapy to the abdomen or pelvis. It is not yet known whether pentosan polysulfate is more effective than no further therapy for treating gastrointestinal disturbance caused by previous radiation therapy.
PURPOSE: Randomized phase III trial to determine the effectiveness of pentosan polysulfate in treating patients who have inflammation of the rectum, diarrhea, or blood in stools caused by previous radiation therapy to the abdomen and pelvis.
- Detailed Description
OBJECTIVES: I. Evaluate the efficacy of pentosan polysulfate in patients with gastrointestinal tract sequelae after radiotherapy to the abdomen and pelvis. II. Determine the toxic effects of this drug in these patients. III. Determine the effect of this drug on symptoms and quality of life of these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral pentosan polysulfate three times a day for 2-6 months. Arm II: Patients receive oral placebo three times a day for 2-6 months. Both arms: Patients may receive retreatment for two months if symptoms return and last for at least 2 weeks. Quality of life is assessed before treatment, and at each follow up visit. Patients are followed every 2 months for 6 months, then every 3 months for 18 months, then annually for 3 years.
PROJECTED ACCRUAL: A total of 174 patients will be accrued for this study within 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 174
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (260)
Albert Einstein Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Comprehensive Cancer Institute of Huntsville
🇺🇸Huntsville, Alabama, United States
Huntsville Hospital System
🇺🇸Huntsville, Alabama, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Veterans Affairs Medical Center - Long Beach
🇺🇸Long Beach, California, United States
Glendale Memorial Hospital and Health Center
🇺🇸Glendale, California, United States
Beckman Research Institute, City of Hope
🇺🇸Los Angeles, California, United States
Radiation Oncology Associates of West Alabama
🇺🇸Tuscaloosa, Alabama, United States
Providence Cancer Therapy Center
🇺🇸Anchorage, Alaska, United States
Urology Associates - Mobile AL
🇺🇸Mobile, Alabama, United States
Ball Memorial Hospital
🇺🇸Muncie, Indiana, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
Saint Agnes Cancer Center
🇺🇸Fresno, California, United States
Mount Diablo Medical Center
🇺🇸Concord, California, United States
Whittingham Cancer Center
🇺🇸Norwalk, Connecticut, United States
Lutheran General Cancer Care Center
🇺🇸Park Ridge, Illinois, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Kaiser Permanente Medical Center - Los Angeles
🇺🇸Los Angeles, California, United States
Bridgeport Hospital
🇺🇸Bridgeport, Connecticut, United States
Northwest Community Hospital
🇺🇸Arlington Heights, Illinois, United States
Radiation Oncology Affiliates of Maryland, P.A.
🇺🇸Baltimore, Maryland, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
St. Joseph's Radiation Oncology Center
🇺🇸South Bend, Indiana, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
Sarasota Radiation and Medical Oncology Center
🇺🇸Sarasota, Florida, United States
St. John's Medical Center
🇺🇸Anderson, Indiana, United States
MidMichigan Regional Medical Center
🇺🇸Midland, Michigan, United States
Tallahassee Memorial Healthcare
🇺🇸Tallahassee, Florida, United States
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
Wendt Regional Cancer Center of Finley Hospital
🇺🇸Dubuque, Iowa, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Merle M. Mahr Cancer Center
🇺🇸Madisonville, Kentucky, United States
Cape Cod Hospital
🇺🇸Hyannis, Massachusetts, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
State University of New York Health Science Center at Brooklyn
🇺🇸Brooklyn, New York, United States
Romagosa Radiation Oncology Center
🇺🇸Lafayette, Louisiana, United States
Akron City Hospital
🇺🇸Akron, Ohio, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
Anne Arundel Oncology Center
🇺🇸Annapolis, Maryland, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
Peninsula Regional Medical Center
🇺🇸Salisbury, Maryland, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
CCOP - Dayton
🇺🇸Kettering, Ohio, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
University of Tennessee, Memphis Cancer Center
🇺🇸Memphis, Tennessee, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
St. John Medical Center
🇺🇸Tulsa, Oklahoma, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Champlain Valley Physicians Hospital Medical Center
🇺🇸Plattsburgh, New York, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Northeastern Ontario Regional Cancer Centre, Sudbury
🇨🇦Sudbury, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
🇨🇦Thunder Bay, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
Ottawa Regional Cancer Centre - General Campus
🇨🇦Ottawa, Ontario, Canada
Kingston Regional Cancer Centre
🇨🇦Kingston, Ontario, Canada
Waukesha Memorial Hospital
🇺🇸Waukesha, Wisconsin, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Veterans Affairs Medical Center - Miami
🇺🇸Miami, Florida, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Community Hospitals of Indianapolis - Regional Cancer Center
🇺🇸Indianapolis, Indiana, United States
Radiation Medical Group, Inc.
🇺🇸San Diego, California, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Vanderbilt Cancer Center
🇺🇸Nashville, Tennessee, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
McLaren Regional Cancer Center
🇺🇸Flint, Michigan, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
UNIMED Medical Center
🇺🇸Minot, North Dakota, United States
Meritcare Roger Maris Cancer Center
🇺🇸Fargo, North Dakota, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Memorial Hospital Cancer Center
🇺🇸Colorado Springs, Colorado, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
St. Anthony Hospital
🇺🇸Oklahoma City, Oklahoma, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
Columbia Hospital
🇺🇸Milwaukee, Wisconsin, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
🇺🇸Milwaukee, Wisconsin, United States
MBCCOP - University of South Alabama
🇺🇸Mobile, Alabama, United States
Alabama Oncology, LLC
🇺🇸Montgomery, Alabama, United States
Mallinckrodt Institute of Radiology
🇺🇸Saint Louis, Missouri, United States
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
California Cancer Center
🇺🇸Fresno, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Cancer Care Center
🇺🇸Pomona, California, United States
Health First Holmes Regional Medical Center
🇺🇸Melbourne, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
🇺🇸Indianapolis, Indiana, United States
Provena St. Joseph Hospital- Regional Cancer Care Center
🇺🇸Elgin, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
Greater Baltimore Medical Center and Cancer Center
🇺🇸Baltimore, Maryland, United States
Harbor Hospital Center
🇺🇸Baltimore, Maryland, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
Community Medical Center
🇺🇸Toms River, New Jersey, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Atlantic City Medical Center
🇺🇸Pomona, New Jersey, United States
Albert Einstein Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
Vassar Brothers Hospital
🇺🇸Poughkeepsie, New York, United States
Akron General Medical Center
🇺🇸Akron, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Mercy Hospital Cancer Center - Scranton
🇺🇸Scranton, Pennsylvania, United States
Veterans Affairs Medical Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
Mercy Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Wilkes Barre General Hospital
🇺🇸Wilkes-Barre, Pennsylvania, United States
Jackson-Madison County General Hospital
🇺🇸Jackson, Tennessee, United States
Baptist Regional Cancer Center - Knoxville
🇺🇸Knoxville, Tennessee, United States
CCOP - Baptist Cancer Institute
🇺🇸Memphis, Tennessee, United States
Dixie Regional Medical Center
🇺🇸Saint George, Utah, United States
Martha Jefferson Hospital
🇺🇸Charlottesville, Virginia, United States
Cancer Center, University of Virginia HSC
🇺🇸Charlottesville, Virginia, United States
Deaconess Medical Center
🇺🇸Spokane, Washington, United States
Dr. H. Bliss Murphy Cancer Centre
🇨🇦St. Johns, Newfoundland and Labrador, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Sutter Health Western Division Cancer Research Group
🇺🇸Greenbrae, California, United States
O'Connor Hospital
🇺🇸San Jose, California, United States
Halifax Medical Center
🇺🇸Daytona Beach, Florida, United States
Lykes Center for Radiation Therapy
🇺🇸Clearwater, Florida, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
West Florida Cancer Institute - Pensacola
🇺🇸Pensacola, Florida, United States
Medical Center/John B. Amos Community Cancer Center
🇺🇸Columbus, Georgia, United States
Florida Radiation Oncology Group
🇺🇸Orange Park, Florida, United States
Bay Medical Center
🇺🇸Panama City, Florida, United States
Gulf Coast Cancer Treatment Center
🇺🇸Panama City, Florida, United States
Bayfront Medical Center
🇺🇸Saint Petersburg, Florida, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
InterCommunity Cancer Center at Rome
🇺🇸Rome, Georgia, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Western Baptist Hospital
🇺🇸Paducah, Kentucky, United States
Clarion Health Partners Inc.
🇺🇸Indianapolis, Indiana, United States
Finger Lakes Radiation Oncology, P.C.
🇺🇸Clifton Springs, New York, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States
Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
Penn State Geisinger Cancer Center
🇺🇸Hershey, Pennsylvania, United States
Mercy Catholic Medical Center, Mercy Fitzgerald Divison
🇺🇸Darby, Pennsylvania, United States
St. Luke's Hospital Regional Cancer Center
🇺🇸Bethlehem, Pennsylvania, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Hahnemann University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
Roger Williams Medical Center/BUSM
🇺🇸Providence, Rhode Island, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Julie and Ben Rogers Cancer Institute
🇺🇸Beaumont, Texas, United States
Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
Wilford Hall - 59th Medical Wing
🇺🇸Lackland Air Force Base, Texas, United States
Joe Arrington Cancer Research and Treatment Center
🇺🇸Lubbock, Texas, United States
East Texas Medical Center - Cancer Institute
🇺🇸Tyler, Texas, United States
Bayshore Medical Center
🇺🇸Pasadena, Texas, United States
RMH Regional Canter Center
🇺🇸Harrisonburg, Virginia, United States
Naval Medical Center, Portsmouth
🇺🇸Portsmouth, Virginia, United States
Virginia Baptist Hospital
🇺🇸Lynchburg, Virginia, United States
Yakima Valley Memorial Hospital
🇺🇸Yakima, Washington, United States
Radiation Oncology Center - Sacramento
🇺🇸Sacramento, California, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
Saint Josephs Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Delaware County Memorial Hospital
🇺🇸Drexel Hill, Pennsylvania, United States
Stanford University
🇺🇸Stanford, California, United States
Catawba Memorial Hospital
🇺🇸Hickory, North Carolina, United States
Radiation Therapy Associates - Fort Myers
🇺🇸Fort Myers, Florida, United States
East Carolina University School of Medicine
🇺🇸Greenville, North Carolina, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
York Hospital
🇺🇸York, Pennsylvania, United States
Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Doctor Leon Richard Oncology Centre
🇨🇦Moncton, New Brunswick, Canada
University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Gundersen Lutheran Medical Foundation
🇺🇸La Crosse, Wisconsin, United States
Community Memorial Hospital
🇺🇸Menomonee Falls, Wisconsin, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
North Mississippi Medical Center/Cancer Center
🇺🇸Tupelo, Mississippi, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Methodist Cancer Center - Omaha
🇺🇸Omaha, Nebraska, United States
Nebraska Health System
🇺🇸Omaha, Nebraska, United States
St. Mary's Medical Center
🇺🇸Saginaw, Michigan, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
South Jersey Hospital - Millville
🇺🇸Millville, New Jersey, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
🇺🇸Jamaica Plain, Massachusetts, United States
Marquette General Hospital
🇺🇸Marquette, Michigan, United States
Veterans Affairs Medical Center - East Orange
🇺🇸East Orange, New Jersey, United States
Trinitas Hospital - Jersey Street Campus
🇺🇸Elizabeth, New Jersey, United States
Associated Radiologists, P.A.
🇺🇸Warren, New Jersey, United States
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
St. Joseph's Hospital
🇺🇸Milwaukee, Wisconsin, United States
Elliot Regional Cancer Center
🇺🇸Manchester, New Hampshire, United States
John F. Kennedy Medical Center
🇺🇸Edison, New Jersey, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Green Mountain Oncology Group
🇺🇸Rutland, Vermont, United States
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
Centre Universitaire de Sante de l'Estrie - Site Fleurimont
🇨🇦Fleurimont, Quebec, Canada
McGill University Department of Oncology
🇨🇦Montreal, Quebec, Canada
Southeastern Wisconsin Regional Cancer Center
🇺🇸Racine, Wisconsin, United States
University of Florida Health Science Center
🇺🇸Gainesville, Florida, United States
MD Anderson Cancer Center Orlando
🇺🇸Orlando, Florida, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
Louisville Radiation Oncology
🇺🇸Louisville, Kentucky, United States
MBCCOP - LSU Medical Center
🇺🇸New Orleans, Louisiana, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Veterans Affairs Medical Center - Lexington
🇺🇸Lexington, Kentucky, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Southern Wisconsin Radiotherapy Center
🇺🇸Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Saint Joseph Medical Center
🇺🇸Albuquerque, New Mexico, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
BC Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
St. Francis Medical Center
🇺🇸Trenton, New Jersey, United States
Northeast Medical Center
🇺🇸Concord, North Carolina, United States
CCOP - Southwestern Vermont Regional Cancer Center
🇺🇸Bennington, Vermont, United States
Schiffler Cancer Center
🇺🇸Wheeling, West Virginia, United States
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
🇺🇸Mount Holly, New Jersey, United States