Pentosan Polysulfate in Treating Patients With Gastrointestinal Disturbance Caused by Radiation Therapy
Phase III Study of Pentosanpolysulfate (PPS) in Treatment of GI Tract Sequelae of Radiotherapy
2 other identifiers
interventional
174
2 countries
260
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
260 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 1999
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
May 3, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2006
CompletedOctober 19, 2020
August 1, 2013
6.8 years
November 1, 1999
October 15, 2020
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Radiation Therapy Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (260)
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294, United States
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, 35801, United States
Huntsville Hospital System
Huntsville, Alabama, 35801, United States
Mobile Infirmary Medical Center
Mobile, Alabama, 36640-0460, United States
Urology Associates - Mobile AL
Mobile, Alabama, 36640, United States
MBCCOP - University of South Alabama
Mobile, Alabama, 36688, United States
Alabama Oncology, LLC
Montgomery, Alabama, 36106-2801, United States
Radiation Oncology Associates of West Alabama
Tuscaloosa, Alabama, 35401, United States
Providence Cancer Therapy Center
Anchorage, Alaska, 99508, United States
Arizona Cancer Center
Tucson, Arizona, 85724, United States
Mount Diablo Medical Center
Concord, California, 94524-4110, United States
California Cancer Center
Fresno, California, 93720, United States
Saint Agnes Cancer Center
Fresno, California, 93720, United States
Glendale Memorial Hospital and Health Center
Glendale, California, 91204, United States
Sutter Health Western Division Cancer Research Group
Greenbrae, California, 94904, United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Veterans Affairs Medical Center - Long Beach
Long Beach, California, 90822, United States
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, 90027, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781, United States
Beckman Research Institute, City of Hope
Los Angeles, California, 91010, United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305, United States
Cancer Care Center
Pomona, California, 91767, United States
Radiation Oncology Center - Sacramento
Sacramento, California, 95816, United States
Radiation Medical Group, Inc.
San Diego, California, 92101-1492, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128, United States
O'Connor Hospital
San Jose, California, 95128, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403, United States
Stanford University
Stanford, California, 94305, United States
Memorial Hospital Cancer Center
Colorado Springs, Colorado, 80909, United States
University of Colorado Cancer Center
Denver, Colorado, 80262, United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
Whittingham Cancer Center
Norwalk, Connecticut, 06856, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000, United States
Lykes Center for Radiation Therapy
Clearwater, Florida, 33757-0210, United States
Halifax Medical Center
Daytona Beach, Florida, 32114, United States
Radiation Therapy Associates - Fort Myers
Fort Myers, Florida, 33901, United States
University of Florida Health Science Center
Gainesville, Florida, 32610-0296, United States
Health First Holmes Regional Medical Center
Melbourne, Florida, 32901, United States
Veterans Affairs Medical Center - Miami
Miami, Florida, 33125, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136, United States
Baptist Hospital of Miami
Miami, Florida, 33176-2197, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Florida Radiation Oncology Group
Orange Park, Florida, 32073, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, 32806, United States
Bay Medical Center
Panama City, Florida, 32401, United States
Gulf Coast Cancer Treatment Center
Panama City, Florida, 32405-4587, United States
West Florida Cancer Institute - Pensacola
Pensacola, Florida, 32514, United States
Sarasota Radiation and Medical Oncology Center
Sarasota, Florida, 34233, United States
Bayfront Medical Center
St. Petersburg, Florida, 33701, United States
Tallahassee Memorial Healthcare
Tallahassee, Florida, 32308, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322, United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701, United States
Medical Center/John B. Amos Community Cancer Center
Columbus, Georgia, 31902, United States
InterCommunity Cancer Center at Rome
Rome, Georgia, 30161, United States
Northwest Community Hospital
Arlington Heights, Illinois, 60005, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637, United States
CCOP - Central Illinois
Decatur, Illinois, 62526, United States
Provena St. Joseph Hospital- Regional Cancer Care Center
Elgin, Illinois, 60123, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
St. John's Medical Center
Anderson, Indiana, 46016, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202, United States
Clarion Health Partners Inc.
Indianapolis, Indiana, 46206-1367, United States
Community Hospitals of Indianapolis - Regional Cancer Center
Indianapolis, Indiana, 46219, United States
Ball Memorial Hospital
Muncie, Indiana, 47303-3499, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
St. Joseph's Radiation Oncology Center
South Bend, Indiana, 46617, United States
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, 52001, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40511-1093, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084, United States
James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
Louisville Radiation Oncology
Louisville, Kentucky, 40215, United States
Merle M. Mahr Cancer Center
Madisonville, Kentucky, 42431, United States
Western Baptist Hospital
Paducah, Kentucky, 42001, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Romagosa Radiation Oncology Center
Lafayette, Louisiana, 70501, United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, 70112, United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112, United States
CCOP - Ochsner
New Orleans, Louisiana, 70121, United States
Maine Medical Center
Portland, Maine, 04102, United States
Anne Arundel Oncology Center
Annapolis, Maryland, 21401, United States
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, 21204, United States
Harbor Hospital Center
Baltimore, Maryland, 21225, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21225, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231, United States
Radiation Oncology Affiliates of Maryland, P.A.
Baltimore, Maryland, 21237, United States
Peninsula Regional Medical Center
Salisbury, Maryland, 21801, United States
Cape Cod Hospital
Hyannis, Massachusetts, 02601, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106, United States
Saint Josephs Mercy Hospital
Ann Arbor, Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
McLaren Regional Cancer Center
Flint, Michigan, 48432, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731, United States
Sparrow Regional Cancer Center
Lansing, Michigan, 48909, United States
Marquette General Hospital
Marquette, Michigan, 49855, United States
MidMichigan Regional Medical Center
Midland, Michigan, 48670, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
St. Mary's Medical Center
Saginaw, Michigan, 48601, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
North Mississippi Medical Center/Cancer Center
Tupelo, Mississippi, 38801, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203, United States
CCOP - Kansas City
Kansas City, Missouri, 64131, United States
Cancer Research for the Ozarks
Springfield, Missouri, 65807, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807, United States
St. Louis University Health Sciences Center
St Louis, Missouri, 63110-0250, United States
Mallinckrodt Institute of Radiology
St Louis, Missouri, 63110, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
Methodist Cancer Center - Omaha
Omaha, Nebraska, 68114, United States
Nebraska Health System
Omaha, Nebraska, 68198-7400, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756, United States
Elliot Regional Cancer Center
Manchester, New Hampshire, 03103, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095, United States
John F. Kennedy Medical Center
Edison, New Jersey, 08818, United States
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, 07201, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
South Jersey Hospital - Millville
Millville, New Jersey, 08332, United States
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Atlantic City Medical Center
Pomona, New Jersey, 08240, United States
Community Medical Center
Toms River, New Jersey, 08755, United States
St. Francis Medical Center
Trenton, New Jersey, 08629, United States
Associated Radiologists, P.A.
Warren Township, New Jersey, 07059, United States
Saint Joseph Medical Center
Albuquerque, New Mexico, 87102, United States
Cancer Center of Albany Medical Center
Albany, New York, 12208, United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203, United States
New York Methodist Hospital
Brooklyn, New York, 11215-3609, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001, United States
Finger Lakes Radiation Oncology, P.C.
Clifton Springs, New York, 14432, United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030, United States
Beth Israel Medical Center
New York, New York, 10003, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, 12901, United States
Vassar Brothers Hospital
Poughkeepsie, New York, 12601, United States
University of Rochester Cancer Center
Rochester, New York, 14642, United States
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, 10461, United States
New York Medical College
Valhalla, New York, 10595, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295, United States
Northeast Medical Center
Concord, North Carolina, 28025, United States
East Carolina University School of Medicine
Greenville, North Carolina, 27858-4354, United States
Catawba Memorial Hospital
Hickory, North Carolina, 28601, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157-1082, United States
Meritcare Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
UNIMED Medical Center
Minot, North Dakota, 58701, United States
Akron General Medical Center
Akron, Ohio, 44302, United States
Akron City Hospital
Akron, Ohio, 44309, United States
Christ Hospital
Cincinnati, Ohio, 45219, United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
CCOP - Columbus
Columbus, Ohio, 43206, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210, United States
CCOP - Dayton
Kettering, Ohio, 45429, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456, United States
St. Anthony Hospital
Oklahoma City, Oklahoma, 73101, United States
St. John Medical Center
Tulsa, Oklahoma, 74104, United States
CCOP - Columbia River Program
Portland, Oregon, 97213, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
St. Luke's Hospital Regional Cancer Center
Bethlehem, Pennsylvania, 18015, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001, United States
Mercy Catholic Medical Center, Mercy Fitzgerald Divison
Darby, Pennsylvania, 19023, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026, United States
Penn State Geisinger Cancer Center
Hershey, Pennsylvania, 17033, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Veterans Affairs Medical Center - Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213, United States
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15219, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052, United States
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, 18501, United States
Wilkes Barre General Hospital
Wilkes-Barre, Pennsylvania, 18764, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096, United States
York Hospital
York, Pennsylvania, 17315, United States
Roger Williams Medical Center/BUSM
Providence, Rhode Island, 02908-4735, United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721, United States
CCOP - Greenville
Greenville, South Carolina, 29615, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709, United States
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301, United States
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, 37901, United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103, United States
CCOP - Baptist Cancer Institute
Memphis, Tennessee, 38117, United States
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838, United States
Harrington Cancer Center
Amarillo, Texas, 79106, United States
Julie and Ben Rogers Cancer Institute
Beaumont, Texas, 77701, United States
University of Texas Medical Branch
Galveston, Texas, 77555-1329, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Wilford Hall - 59th Medical Wing
Lackland Air Force Base, Texas, 78236-5300, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410-1894, United States
Bayshore Medical Center
Pasadena, Texas, 77504, United States
East Texas Medical Center - Cancer Institute
Tyler, Texas, 75701, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Dixie Regional Medical Center
St. George, Utah, 84770, United States
CCOP - Southwestern Vermont Regional Cancer Center
Bennington, Vermont, 05201, United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498, United States
Green Mountain Oncology Group
Rutland, Vermont, 05701, United States
Martha Jefferson Hospital
Charlottesville, Virginia, 22901, United States
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, 22908, United States
RMH Regional Canter Center
Harrisonburg, Virginia, 22801, United States
Virginia Baptist Hospital
Lynchburg, Virginia, 24503, United States
Naval Medical Center, Portsmouth
Portsmouth, Virginia, 23708-2197, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Virginia Mason Medical Center
Seattle, Washington, 98111, United States
Deaconess Medical Center
Spokane, Washington, 99210-0248, United States
Yakima Valley Memorial Hospital
Yakima, Washington, 98902, United States
Schiffler Cancer Center
Wheeling, West Virginia, 26003, United States
St. Vincent Hospital
Green Bay, Wisconsin, 54307-3508, United States
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, 54601, United States
Southern Wisconsin Radiotherapy Center
Madison, Wisconsin, 53713, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Community Memorial Hospital
Menomonee Falls, Wisconsin, 53051, United States
St. Joseph's Hospital
Milwaukee, Wisconsin, 53210, United States
Columbia Hospital
Milwaukee, Wisconsin, 53211, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295, United States
Southeastern Wisconsin Regional Cancer Center
Racine, Wisconsin, 53405, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
BC Cancer Agency
Vancouver, British Columbia, V5Z 4E6, Canada
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3, Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Greater Sudbury, Ontario, P3E 5J1, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6, Canada
Ottawa Regional Cancer Centre - General Campus
Ottawa, Ontario, K1H 1C4, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, P7A 7T1, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Centre Universitaire de Sante de l'Estrie - Site Fleurimont
Fleurimont, Quebec, J1H 5N4, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L-4M1, Canada
McGill University Department of Oncology
Montreal, Quebec, H2W 1S6, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Related Publications (1)
Pilepich MV, Paulus R, St Clair W, Brasacchio RA, Rostock R, Miller RC. Phase III study of pentosanpolysulfate (PPS) in treatment of gastrointestinal tract sequelae of radiotherapy. Am J Clin Oncol. 2006 Apr;29(2):132-7. doi: 10.1097/01.coc.0000203758.77490.fd.
PMID: 16601430RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Miljenko V. Pilepich, MD
Saint Joseph Mercy Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE CARE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
May 3, 2004
Study Start
June 1, 1999
Primary Completion
April 1, 2006
Last Updated
October 19, 2020
Record last verified: 2013-08