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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00003825
Other study ID # RTOG-9809
Secondary ID CDR0000066979
Status Completed
Phase Phase 3
First received
Last updated
Start date June 1999

Study information

Verified date August 2013
Source Radiation Therapy Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 174
Est. completion date
Est. primary completion date April 2006
Accepts healthy volunteers No
Gender All
Age group N/A to 120 Years
Eligibility DISEASE CHARACTERISTICS: Must have received prior radiotherapy to the abdomen and pelvis and now have radiation related gastrointestinal symptoms (which were not present before the radiotherapy and/or attributed to other causes) Proctitis Diarrhea Melena (blood in stools) Severity of symptoms classified as grade 1, 2, or 3 PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No bleeding ulcers No bleeding diathesis PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 1 month since prior chemotherapy No concurrent chemotherapy Endocrine therapy: Concurrent hormonal therapy for prostate cancer allowed Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: No prior bowel resection At least 3 weeks since prior surgery Other: No concurrent anticoagulation therapy (except aspirin)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
pentosan polysulfate sodium

Procedure:
quality-of-life assessment


Locations

Country Name City State
Canada Tom Baker Cancer Center - Calgary Calgary Alberta
Canada Cross Cancer Institute Edmonton Alberta
Canada Centre Universitaire de Sante de l'Estrie - Site Fleurimont Fleurimont Quebec
Canada Nova Scotia Cancer Centre Halifax Nova Scotia
Canada Cancer Care Ontario-Hamilton Regional Cancer Centre Hamilton Ontario
Canada Kingston Regional Cancer Centre Kingston Ontario
Canada Cancer Care Ontario-London Regional Cancer Centre London Ontario
Canada Doctor Leon Richard Oncology Centre Moncton New Brunswick
Canada Centre Hospitalier de l'Universite de Montreal Montreal Quebec
Canada McGill University Department of Oncology Montreal Quebec
Canada Ottawa Regional Cancer Centre - General Campus Ottawa Ontario
Canada Saint John Regional Hospital Saint John New Brunswick
Canada Saskatoon Cancer Centre Saskatoon Saskatchewan
Canada Dr. H. Bliss Murphy Cancer Centre St. Johns Newfoundland and Labrador
Canada Northeastern Ontario Regional Cancer Centre, Sudbury Sudbury Ontario
Canada Northwestern Ontario Regional Cancer Centre, Thunder Bay Thunder Bay Ontario
Canada Princess Margaret Hospital Toronto Ontario
Canada Toronto Sunnybrook Regional Cancer Centre Toronto Ontario
Canada BC Cancer Agency Vancouver British Columbia
United States Akron City Hospital Akron Ohio
United States Akron General Medical Center Akron Ohio
United States Cancer Center of Albany Medical Center Albany New York
United States Saint Joseph Medical Center Albuquerque New Mexico
United States Lehigh Valley Hospital Allentown Pennsylvania
United States Harrington Cancer Center Amarillo Texas
United States Providence Cancer Therapy Center Anchorage Alaska
United States St. John's Medical Center Anderson Indiana
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 Anne Arundel Oncology Center Annapolis Maryland
United States Northwest Community Hospital Arlington Heights Illinois
United States CCOP - Atlanta Regional Atlanta Georgia
United States Emory University Hospital - Atlanta Atlanta Georgia
United States Greater Baltimore Medical Center and Cancer Center Baltimore Maryland
United States Harbor Hospital Center Baltimore Maryland
United States Johns Hopkins Oncology Center Baltimore Maryland
United States Radiation Oncology Affiliates of Maryland, P.A. Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States Mary Bird Perkins Cancer Center Baton Rouge Louisiana
United States Julie and Ben Rogers Cancer Institute Beaumont Texas
United States CCOP - Southwestern Vermont Regional Cancer Center Bennington Vermont
United States St. Luke's Hospital Regional Cancer Center Bethlehem Pennsylvania
United States CCOP - Montana Cancer Consortium Billings Montana
United States University of Alabama Comprehensive Cancer Center Birmingham Alabama
United States Bridgeport Hospital Bridgeport Connecticut
United States Albert Einstein Comprehensive Cancer Center Bronx New York
United States New York Methodist Hospital Brooklyn New York
United States State University of New York Health Science Center at Brooklyn Brooklyn New York
United States Roswell Park Cancer Institute Buffalo New York
United States Vermont Cancer Center Burlington Vermont
United States Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Cancer Center, University of Virginia HSC Charlottesville Virginia
United States Martha Jefferson Hospital Charlottesville Virginia
United States Northwestern Memorial Hospital Chicago Illinois
United States University of Chicago Cancer Research Center Chicago Illinois
United States Christ Hospital Cincinnati Ohio
United States Lykes Center for Radiation Therapy Clearwater Florida
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States Ireland Cancer Center Cleveland Ohio
United States University Hospitals of Cleveland Cleveland Ohio
United States Finger Lakes Radiation Oncology, P.C. Clifton Springs New York
United States Memorial Hospital Cancer Center Colorado Springs Colorado
United States Ellis Fischel Cancer Center - Columbia Columbia Missouri
United States Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio
United States CCOP - Columbus Columbus Ohio
United States Medical Center/John B. Amos Community Cancer Center Columbus Georgia
United States Mount Diablo Medical Center Concord California
United States Northeast Medical Center Concord North Carolina
United States Geisinger Medical Center Danville Pennsylvania
United States Mercy Catholic Medical Center, Mercy Fitzgerald Divison Darby Pennsylvania
United States Halifax Medical Center Daytona Beach Florida
United States CCOP - Central Illinois Decatur Illinois
United States University of Colorado Cancer Center Denver Colorado
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States Henry Ford Hospital Detroit Michigan
United States Delaware County Memorial Hospital Drexel Hill Pennsylvania
United States Wendt Regional Cancer Center of Finley Hospital Dubuque Iowa
United States Veterans Affairs Medical Center - East Orange East Orange New Jersey
United States John F. Kennedy Medical Center Edison New Jersey
United States Provena St. Joseph Hospital- Regional Cancer Care Center Elgin Illinois
United States Trinitas Hospital - Jersey Street Campus Elizabeth New Jersey
United States Meritcare Roger Maris Cancer Center Fargo North Dakota
United States Hurley Medical Center Flint Michigan
United States McLaren Regional Cancer Center Flint Michigan
United States Radiation Therapy Associates - Fort Myers Fort Myers Florida
United States California Cancer Center Fresno California
United States Saint Agnes Cancer Center Fresno California
United States University of Florida Health Science Center Gainesville Florida
United States University of Texas Medical Branch Galveston Texas
United States Glendale Memorial Hospital and Health Center Glendale California
United States St. Vincent Hospital Green Bay Wisconsin
United States Sutter Health Western Division Cancer Research Group Greenbrae California
United States CCOP - Greenville Greenville South Carolina
United States East Carolina University School of Medicine Greenville North Carolina
United States RMH Regional Canter Center Harrisonburg Virginia
United States Ingalls Memorial Hospital Harvey Illinois
United States Penn State Geisinger Cancer Center Hershey Pennsylvania
United States Catawba Memorial Hospital Hickory North Carolina
United States University of Texas - MD Anderson Cancer Center Houston Texas
United States Comprehensive Cancer Institute of Huntsville Huntsville Alabama
United States Huntsville Hospital System Huntsville Alabama
United States Cape Cod Hospital Hyannis Massachusetts
United States Clarion Health Partners Inc. Indianapolis Indiana
United States Community Hospitals of Indianapolis - Regional Cancer Center Indianapolis Indiana
United States Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis Indiana
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States Jackson-Madison County General Hospital Jackson Tennessee
United States Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain Massachusetts
United States CCOP - Kalamazoo Kalamazoo Michigan
United States CCOP - Kansas City Kansas City Missouri
United States CCOP - Dayton Kettering Ohio
United States Baptist Regional Cancer Center - Knoxville Knoxville Tennessee
United States Gundersen Lutheran Medical Foundation La Crosse Wisconsin
United States University of California San Diego Cancer Center La Jolla California
United States Wilford Hall - 59th Medical Wing Lackland Air Force Base Texas
United States Romagosa Radiation Oncology Center Lafayette Louisiana
United States Sparrow Regional Cancer Center Lansing Michigan
United States CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada
United States Norris Cotton Cancer Center Lebanon New Hampshire
United States Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky
United States Veterans Affairs Medical Center - Lexington Lexington Kentucky
United States Loma Linda University Medical Center Loma Linda California
United States Veterans Affairs Medical Center - Long Beach Long Beach California
United States Monmouth Medical Center Long Branch New Jersey
United States Beckman Research Institute, City of Hope Los Angeles California
United States Jonsson Comprehensive Cancer Center, UCLA Los Angeles California
United States Kaiser Permanente Medical Center - Los Angeles Los Angeles California
United States USC/Norris Comprehensive Cancer Center Los Angeles California
United States James Graham Brown Cancer Center Louisville Kentucky
United States Louisville Radiation Oncology Louisville Kentucky
United States Joe Arrington Cancer Research and Treatment Center Lubbock Texas
United States Virginia Baptist Hospital Lynchburg Virginia
United States Southern Wisconsin Radiotherapy Center Madison Wisconsin
United States University of Wisconsin Comprehensive Cancer Center Madison Wisconsin
United States Merle M. Mahr Cancer Center Madisonville Kentucky
United States Elliot Regional Cancer Center Manchester New Hampshire
United States CCOP - North Shore University Hospital Manhasset New York
United States Marquette General Hospital Marquette Michigan
United States Marshfield Clinic Marshfield Wisconsin
United States Loyola University Medical Center Maywood Illinois
United States Health First Holmes Regional Medical Center Melbourne Florida
United States CCOP - Baptist Cancer Institute Memphis Tennessee
United States University of Tennessee, Memphis Cancer Center Memphis Tennessee
United States Community Memorial Hospital Menomonee Falls Wisconsin
United States Baptist Hospital of Miami Miami Florida
United States Sylvester Cancer Center, University of Miami Miami Florida
United States Veterans Affairs Medical Center - Miami Miami Florida
United States CCOP - Mount Sinai Medical Center Miami Beach Florida
United States MidMichigan Regional Medical Center Midland Michigan
United States South Jersey Hospital - Millville Millville New Jersey
United States Columbia Hospital Milwaukee Wisconsin
United States Medical College of Wisconsin Milwaukee Wisconsin
United States St. Joseph's Hospital Milwaukee Wisconsin
United States St. Luke's Medical Center Milwaukee Wisconsin
United States Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee Wisconsin
United States UNIMED Medical Center Minot North Dakota
United States MBCCOP - University of South Alabama Mobile Alabama
United States Mobile Infirmary Medical Center Mobile Alabama
United States Urology Associates - Mobile AL Mobile Alabama
United States Alabama Oncology, LLC Montgomery Alabama
United States Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County Mount Holly New Jersey
United States Ball Memorial Hospital Muncie Indiana
United States Vanderbilt Cancer Center Nashville Tennessee
United States Cancer Institute of New Jersey New Brunswick New Jersey
United States CCOP - Ochsner New Orleans Louisiana
United States MBCCOP - LSU Medical Center New Orleans Louisiana
United States Tulane University School of Medicine New Orleans Louisiana
United States Beth Israel Medical Center New York New York
United States Herbert Irving Comprehensive Cancer Center New York New York
United States Memorial Sloan-Kettering Cancer Center New York New York
United States NYU School of Medicine's Kaplan Comprehensive Cancer Center New York New York
United States Newark Beth Israel Medical Center Newark New Jersey
United States Whittingham Cancer Center Norwalk Connecticut
United States CCOP - Bay Area Tumor Institute Oakland California
United States St. Anthony Hospital Oklahoma City Oklahoma
United States Methodist Cancer Center - Omaha Omaha Nebraska
United States Nebraska Health System Omaha Nebraska
United States Florida Radiation Oncology Group Orange Park Florida
United States MD Anderson Cancer Center Orlando Orlando Florida
United States Western Baptist Hospital Paducah Kentucky
United States Bay Medical Center Panama City Florida
United States Gulf Coast Cancer Treatment Center Panama City Florida
United States Lutheran General Cancer Care Center Park Ridge Illinois
United States Bayshore Medical Center Pasadena Texas
United States West Florida Cancer Institute - Pensacola Pensacola Florida
United States Methodist Medical Center of Illinois Peoria Illinois
United States Albert Einstein Cancer Center Philadelphia Pennsylvania
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Hahnemann University Hospital Philadelphia Pennsylvania
United States Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania
United States University of Pennsylvania Cancer Center Philadelphia Pennsylvania
United States Veterans Affairs Medical Center - Philadelphia Philadelphia Pennsylvania
United States Mercy Hospital of Pittsburgh Pittsburgh Pennsylvania
United States University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania
United States Western Pennsylvania Hospital Pittsburgh Pennsylvania
United States Champlain Valley Physicians Hospital Medical Center Plattsburgh New York
United States Atlantic City Medical Center Pomona New Jersey
United States Cancer Care Center Pomona California
United States CCOP - Columbia River Program Portland Oregon
United States Maine Medical Center Portland Maine
United States Naval Medical Center, Portsmouth Portsmouth Virginia
United States Vassar Brothers Hospital Poughkeepsie New York
United States Roger Williams Medical Center/BUSM Providence Rhode Island
United States Southeastern Wisconsin Regional Cancer Center Racine Wisconsin
United States Rapid City Regional Hospital Rapid City South Dakota
United States Reading Hospital and Medical Center Reading Pennsylvania
United States Mayo Clinic Cancer Center Rochester Minnesota
United States University of Rochester Cancer Center Rochester New York
United States InterCommunity Cancer Center at Rome Rome Georgia
United States William Beaumont Hospital Royal Oak Michigan
United States Green Mountain Oncology Group Rutland Vermont
United States Radiation Oncology Center - Sacramento Sacramento California
United States St. Mary's Medical Center Saginaw Michigan
United States Dixie Regional Medical Center Saint George Utah
United States Mallinckrodt Institute of Radiology Saint Louis Missouri
United States St. Louis University Health Sciences Center Saint Louis Missouri
United States CCOP - Metro-Minnesota Saint Louis Park Minnesota
United States Bayfront Medical Center Saint Petersburg Florida
United States Peninsula Regional Medical Center Salisbury Maryland
United States LDS Hospital Salt Lake City Utah
United States University of Utah Health Sciences Center Salt Lake City Utah
United States Radiation Medical Group, Inc. San Diego California
United States UCSF Cancer Center and Cancer Research Institute San Francisco California
United States O'Connor Hospital San Jose California
United States CCOP - Santa Rosa Memorial Hospital Santa Rosa California
United States Sarasota Radiation and Medical Oncology Center Sarasota Florida
United States Mercy Hospital Cancer Center - Scranton Scranton Pennsylvania
United States Swedish Cancer Institute Seattle Washington
United States Virginia Mason Medical Center Seattle Washington
United States Memorial Hospital of South Bend South Bend Indiana
United States St. Joseph's Radiation Oncology Center South Bend Indiana
United States CCOP - Upstate Carolina Spartanburg South Carolina
United States Deaconess Medical Center Spokane Washington
United States Cancer Research for the Ozarks Springfield Missouri
United States CCOP - Cancer Research for the Ozarks Springfield Missouri
United States Stanford University Stanford California
United States Tallahassee Memorial Healthcare Tallahassee Florida
United States H. Lee Moffitt Cancer Center and Research Institute Tampa Florida
United States CCOP - Toledo Community Hospital Oncology Program Toledo Ohio
United States Community Medical Center Toms River New Jersey
United States St. Francis Medical Center Trenton New Jersey
United States Arizona Cancer Center Tucson Arizona
United States St. John Medical Center Tulsa Oklahoma
United States North Mississippi Medical Center/Cancer Center Tupelo Mississippi
United States Radiation Oncology Associates of West Alabama Tuscaloosa Alabama
United States East Texas Medical Center - Cancer Institute Tyler Texas
United States New York Medical College Valhalla New York
United States Associated Radiologists, P.A. Warren New Jersey
United States Walter Reed Army Medical Center Washington District of Columbia
United States Waukesha Memorial Hospital Waukesha Wisconsin
United States Schiffler Cancer Center Wheeling West Virginia
United States Wilkes Barre General Hospital Wilkes-Barre Pennsylvania
United States CCOP - Christiana Care Health Services Wilmington Delaware
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 CCOP - MainLine Health Wynnewood Pennsylvania
United States Yakima Valley Memorial Hospital Yakima Washington
United States York Hospital York Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Radiation Therapy Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & 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. — View Citation

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