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Pentosan polysulfat i behandling av pasienter med gastrointestinale forstyrrelser forårsaket av strålebehandling

15. oktober 2020 oppdatert av: Radiation Therapy Oncology Group

Fase III-studie av Pentosanpolysulfat (PPS) i behandling av GI-kanal-følger av strålebehandling

BAKGRUNN: Pentosan polysulfat kan være effektiv i behandling av bivirkninger av strålebehandling til magen eller bekkenet. Det er ennå ikke kjent om pentosanpolysulfat er mer effektivt enn ingen ytterligere terapi for behandling av gastrointestinale forstyrrelser forårsaket av tidligere strålebehandling.

FORMÅL: Randomisert fase III-studie for å bestemme effektiviteten av pentosanpolysulfat ved behandling av pasienter som har betennelse i endetarmen, diaré eller blod i avføring forårsaket av tidligere strålebehandling til magen og bekkenet.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

MÅL: I. Evaluere effekten av pentosanpolysulfat hos pasienter med følgetilstander i mage-tarmkanalen etter strålebehandling mot mage og bekken. II. Bestem de toksiske effektene av dette stoffet hos disse pasientene. III. Bestem effekten av dette stoffet på symptomene og livskvaliteten til disse pasientene.

OVERSIKT: Dette er en randomisert studie. Pasientene er randomisert til 1 av 2 behandlingsarmer. Arm I: Pasienter får oralt pentosanpolysulfat tre ganger daglig i 2-6 måneder. Arm II: Pasienter får oral placebo tre ganger daglig i 2-6 måneder. Begge armer: Pasienter kan få ny behandling i to måneder hvis symptomene kommer tilbake og varer i minst 2 uker. Livskvalitet vurderes før behandling, og ved hvert oppfølgingsbesøk. Pasientene følges hver 2. måned i 6 måneder, deretter hver 3. måned i 18 måneder, deretter årlig i 3 år.

PROSJERT PASSERING: Totalt 174 pasienter vil bli påløpt for denne studien innen 3 år.

Studietype

Intervensjonell

Registrering (Forventet)

174

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

1 sekund til 120 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

SYKDOMS KARAKTERISTIKA: Må ha mottatt tidligere strålebehandling av magen og bekkenet og har nå strålerelaterte gastrointestinale symptomer (som ikke var tilstede før strålebehandlingen og/eller tilskrives andre årsaker) Proktitt Diaré Melena (blod i avføringen) Alvorligheten av symptomene klassifisert som grad 1, 2 eller 3

PASIENT KARAKTERISTIKA: Alder: Alle aldre Ytelsesstatus: Ikke spesifisert Forventet levealder: Ikke spesifisert Hematopoetisk: Ikke spesifisert Lever: Ikke spesifisert Nyre: Ikke spesifisert Annet: Ingen blødende sår Ingen blødende diatese

TIDLIGERE SAMTIDIG BEHANDLING: Biologisk behandling: Ikke spesifisert Kjemoterapi: Minst 1 måned siden tidligere kjemoterapi Ingen samtidig kjemoterapi Endokrin terapi: Samtidig hormonbehandling for prostatakreft tillatt Strålebehandling: Se Sykdomskarakteristikker Minst 4 uker siden tidligere strålebehandling Kirurgi: Ingen tidligere tarmreseksjon Kl. minst 3 uker siden tidligere operasjon Annet: Ingen samtidig antikoagulasjonsbehandling (unntatt aspirin)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Radiation Therapy Oncology Group

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Studiestol: Miljenko V. Pilepich, MD, Saint Joseph Mercy Cancer Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 1999

Primær fullføring (Faktiske)

1. april 2006

Datoer for studieregistrering

Først innsendt

1. november 1999

Først innsendt som oppfylte QC-kriteriene

30. april 2004

Først lagt ut (Anslag)

3. mai 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. oktober 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. oktober 2020

Sist bekreftet

1. august 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RTOG-9809
  • CDR0000066979

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på livskvalitetsvurdering

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Latvia

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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