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RTOG 9809 Protocol Information

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Phase III Study of Pentosanpolysulfate (PPS) in Treatment of GI Tract Sequelae of Radiotherapy
Protocol Documents
Current Version Date: 10/26/1999
Principal Investigator: Miljenko Pilepich, M.D.
Primary Objective:
  • To evaluate the effectiveness of pentosanpolysulfate (PPS) in the treatment of the sequelae of abdominal and pelvic irradiation.
  • To assess the potential toxicity of pentosanpolysulfate or to document the lack of toxicity.
  • To evaluate the effectiveness of PPS in improving symptoms and quality of life scores.
Patient Population:
  • Patients with Grades 1 to 3 symptoms of radiation related proctitis, diarrhea and/or melena following completion of radiotherapy.
  • At least four weeks must have elapsed since the completion of radiotherapy course.
  • No bleeding diathesis, peptic ulcers, bleeding ulcers.
  • No anticoagulation therapy.
  • No concurrent chemotherapy or on any chemotherapy less than a month prior to accession to the study.
  • No recent surgery (less than three weeks prior to randomization). History of bowel resection makes the patient not eligible.
  • Prior or concurrent hormones for prostate cancer are permissible.
  • Signed study-specific consent form prior to randomization.
Target Accrual: 174
Current Accrual: 180
Status: Terminated
Date: 10/18/2002
Participating Sites:
Arizona Oncology Services Foundation Scottsdale AZ
Atlanta Regional CCOP Atlanta GA
Aurora Saint Luke's Medical Center Milwaukee WI
Baptist Cancer Institute Jacksonville FL
Baptist Health Lexington Lexington KY
Baptist Hospital of East Tennessee Knoxville TN
Bay Area Tumor Institute Oakland CA
Bay Medical Center Panama City FL
Cape Cod Hospital Hyannis MA
Champlain Valley Physicians Hospital Medical Center Plattsburgh NY
Christiana Care Health System-Christiana Hospital Newark DE
Cleveland Clinic Foundation Cleveland OH
Clifton Springs Hospital and Clinic Clifton Springs NY
Columbia Saint Mary's Water Tower Medical Commons Milwaukee WI
Columbus CCOP Columbus OH
Community Medical Center Toms River NJ
Community Memorial Hospital Menomonee Falls WI
Cottonwood Hospital Medical Center Murray UT
Dayton CCOP Kettering OH
Delaware County Memorial Hospital Drexel Hill PA
Dixie Medical Center Regional Cancer Center East St. George UT
Einstein Medical Center Philadelphia Philadelphia PA
Finley Hospital Dubuque IA
Froedtert and the Medical College of Wisconsin Milwaukee WI
Greater Baltimore Medical Center Baltimore MD
Greenville Health System Cancer Institute-Eastside Greenville SC
Gulf Coast Cancer Treatment Center Panama City FL
Halifax Health Medical Center-Centers for Oncology Daytona Beach FL
Holmes Regional Medical Center Melbourne FL
Indiana University Health Methodist Hospital Indianapolis IN
Inspira Medical Center Vineland Vineland NJ
Jackson-Madison County General Hospital Jackson TN
John F Kennedy Medical Center Edison NJ
Kalamazoo CCOP-West Michigan Cancer Center Kalamazoo MI
Kansas City CCOP Prairie Village KS
Kingston Health Sciences Centre Kingston, Ontario
LDS Hospital Salt Lake City UT
Lewis and Faye Manderson Cancer Center Tuscaloosa AL
Loma Linda University Medical Center Loma Linda CA
Mary Bird Perkins Cancer Center Baton Rouge LA
Methodist Medical Center of Illinois Peoria IL
Metro-Minnesota CCOP St. Louis Park MN
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor MI
Missouri Valley Cancer Consortium Omaha NE
Mobile Infirmary Medical Center Mobile AL
Monmouth Medical Center Long Branch NJ
Natalie Warren Bryant Cancer Center at Saint Francis Tulsa OK
Nebraska Methodist Hospital Omaha NE
North Shore-LIJ Health System CCOP Manhasset NY
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima WA
Northwest Community Clinical Oncology Program Tacoma WA
Northwestern University Chicago IL
Ochsner Medical Center Jefferson New Orleans LA
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Springfield MO
QEII Health Sciences Centre/Nova Scotia Health Authority Halifax, Nova Scotia
Radiation Oncology Affiliates of Maryland Baltimore MD
Radiation Oncology Associates of W. Alabama PC Tuscaloosa AL
Regional Hospital of Scranton Scranton PA
Romagosa Radiation Oncology Center Lafayette LA
Saint Agnes Medical Center Fresno CA
Saint Francis Medical Center Trenton NJ
Saint Mary's Hospital and Regional Medical Center Grand Junction CO
Saint Vincent Hospital Cancer Center Green Bay Green Bay WI
Santa Rosa Memorial Hospital Santa Rosa CA
Sarasota Radiation & Medical Oncology Center Sarasota FL
Sentara Martha Jefferson Hospital Charlottesville VA
Southeast Cancer Control Consortium CCOP Winston Salem NC
Summa Akron City Hospital/Cooper Cancer Center Akron OH
Sutter Cancer Research Consortium Novato CA
Swedish Medical Center-First Hill Seattle WA
Tallahassee Memorial HealthCare Tallahassee FL
The Don and Sybil Harrington Cancer Center Amarillo TX
The James Graham Brown Cancer Center at University of Louisville Louisville KY
Thomas Jefferson University Hospital Philadelphia PA
Toledo Community Hospital Oncology Program CCOP Toledo OH
Trinity Cancer Care Center Minot ND
Trinity Cancer Care Center Minot ND
University of Alabama at Birmingham Cancer Center Birmingham AL
University of Arizona Medical Center-University Campus Tucson AZ
University of California Davis Comprehensive Cancer Center Sacramento CA
University of Kentucky/Markey Cancer Center Lexington KY
University of Maryland Saint Joseph Medical Center Towson MD
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami FL
University of Pennsylvania Medical Center Philadelphia PA
University of Rochester Rochester NY
University of South Alabama Mobile AL
University of Texas Medical Branch Galveston TX
UPMC-Mercy Hospital Pittsburgh PA
UPMC-Presbyterian Hospital Pittsburgh PA
Upstate Carolina CCOP Spartanburg SC
Vassar Brothers Medical Center Poughkeepsie NY
Veterans Affairs Medical Center - Miami, Florida Miami FL
Virginia Commonwealth University/Massey Cancer Center Richmond VA
Virginia Mason CCOP Seattle WA
Virginia Mason Medical Center Seattle WA
Wake Forest University Health Sciences Winston-Salem NC
Warren Radiation Therapy Center Warren NJ
Washington University School of Medicine St. Louis MO
WellSpan Health-York Hospital York PA
West Penn Hospital Pittsburgh PA
Western Oncology Research Consortium Portland OR
Wheaton Franciscan Cancer Care-All Saints Racine WI
William Beaumont Hospital-Royal Oak Royal Oak MI
Wyoming Valley Health Care System - Hospital Wilkes-Barre PA
Zablocki VA Medical Center-Wood Milwaukee WI
Updated: 4/13/2011

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