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NCT00006366

Radioterapia combinada con quimioterapia, seguida de cirugía, en el tratamiento de pacientes con cáncer de recto localmente avanzado.

Completado Fase 2

Descripción

JUSTIFICACIÓN: La radioterapia utiliza rayos X de alta energía para dañar las células tumorales. Los fármacos utilizados en la quimioterapia emplean diferentes mecanismos para impedir la división de las células tumorales, de modo que dejen de crecer o mueran. Aún no se sabe qué régimen de radioterapia más quimioterapia es más eficaz para el cáncer de recto.

OBJETIVO: Ensayo aleatorizado de fase II para comparar dos regímenes de radioterapia más quimioterapia, seguidos de cirugía, en el tratamiento de pacientes con cáncer de recto localmente avanzado.

Evidencia de la diana molecular en cáncer colorrectal

Aún no hay evidencia documentada en nuestra base para la diana o el fármaco de este ensayo. Esta sección crece a medida que se procesan nuevas publicaciones.

Criterios de Elegibilidad

CARACTERÍSTICAS DE LA ENFERMEDAD:

  • Adenocarcinoma confirmado histológicamente del recto distal
  • Localizado entre 0 y 9 cm desde la línea dentada (entre 3 y 12 cm desde el borde anal)
  • Sin extensión de la enfermedad maligna hacia el canal anal
  • Las lesiones pueden ser de estadio T3 móvil según la ecografía endorrectal O fijas, definidas como estadio clínico T4, mediante palpación
  • Sin evidencia de metástasis a distancia

CARACTERÍSTICAS DEL PACIENTE:

Edad:

  • Mayor de 18 años

Estado funcional:

  • Zubrod 0-1

Esperanza de vida:

  • No especificado

Hematopoyético:

  • Recuento de glóbulos blancos (WBC) mayor de 4.000/mm³
  • Recuento de plaquetas mayor de 130.000/mm³

Hepático:

  • Bilirrubina no mayor de 1,5 veces el límite superior de la normalidad
  • Fosfatasa alcalina, SGOT (transaminasa glutámico oxaloacética sérica) y LDH (lactato deshidrogenasa) normales

Renal:

  • Creatinina normal

Otros:

  • No embarazada ni en período de lactancia
  • Los pacientes fértiles deben utilizar métodos anticonceptivos eficaces
  • No debe haber otra neoplasia invasiva en los últimos 5 años, excepto:
  • Cáncer de piel no melanoma inactivo
  • Carcinoma in situ del cuello uterino
  • Cáncer colorrectal sincrónico si el tumor es Tis o T1 y ha sido resecado por completo
  • No debe haber otras enfermedades médicas graves

TERAPIA ANTERIOR O CONCURRENTE:

Terapia biológica:

  • No especificado

Quimioterapia:

  • No se ha administrado quimioterapia previa

Terapia endocrina:

  • No especificado

Radioterapia:

  • No se ha administrado radioterapia previa en la pelvis

Cirugía:

  • No especificado

Otros:

  • No se deben administrar fármacos antiepilépticos de forma concurrente

Información del Ensayo

NCT00006366
Completado
Fase 2
100 participantes
Feb 2001

Ubicaciones235

Canada (19)
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Newfoundland Cancer Treatment and Research Foundation
St. John's, Newfoundland and Labrador, A1B 3V6
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Northeastern Ontario Regional Cancer Centre, Sudbury
Greater Sudbury, Ontario, P3E 5J1
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, P7A 7T1
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L 4MI
McGill University
Montreal, Quebec, H2W 1S6
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, G1R 2J6
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
United States (216)
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, 35801
Huntsville Hospital System
Huntsville, Alabama, 35807
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
Alabama Oncology, LLC
Montgomery, Alabama, 36106-3657
Radiation Oncology Associates of West Alabama
Tuscaloosa, Alabama, 35401
Foundation for Cancer Research and Education
Phoenix, Arizona, 85013
Mount Diablo Medical Center
Concord, California, 94524-4110
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
California Cancer Center
Fresno, California, 93729-5100
Saint Agnes Cancer Center
Fresno, California, 93720
Sutter Health West Cancer Research Group
Greenbrae, California, 94904
Loma Linda University Medical Center
Loma Linda, California, 92354
Veterans Affairs Medical Center - Long Beach
Long Beach, California, 90822
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90025-1781
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
Huntington Cancer Center
Pasadena, California, 91105
Cancer Care Center
Pomona, California, 91767
Radiation Oncology Center - Sacramento
Sacramento, California, 95816
Radiation Medical Group, Inc.
San Diego, California, 92101
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
O'Connor Hospital
San Jose, California, 95128
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
David Grant Medical Center
Travis Air Force Base, California, 94535
Memorial Hospital Cancer Center
Colorado Springs, Colorado, 80909
University of Colorado Cancer Center
Denver, Colorado, 80010
Saint Mary's Hospital and Medical Center
Grand Junction, Colorado, 81502-1628
Hospital of St. Raphael
New Haven, Connecticut, 06511
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
University of Florida Health Science Center
Gainesville, Florida, 32610-0385
Florida Radiation Oncology Group
Jacksonville, Florida, 32207
Health First Holmes Regional Medical Center
Melbourne, Florida, 32901-3276
Baptist Hospital of Miami
Miami, Florida, 33256-2110
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
Veterans Affairs Medical Center - Miami
Miami, Florida, 33125
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140
MD Anderson Cancer Center Orlando
Orlando, Florida, 32806
Bay Medical Center
Panama City, Florida, 32401
Gulf Coast Cancer Treatment Center
Panama City, Florida, 32405-4587
Sarasota Radiation and Medical Oncology Center
Sarasota, Florida, 34233
Tallahassee Memorial Healthcare
Tallahassee, Florida, 32308
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
Medical Center/John B. Amos Community Cancer Center
Columbus, Georgia, 31901
Regional Radiation Oncology Center at Rome
Rome, Georgia, 30165
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
Northwest Community Hospital
Arlington Heights, Illinois, 60005
Northwestern Memorial Hospital
Chicago, Illinois, 60611
CCOP - Central Illinois
Decatur, Illinois, 62526
Ingalls Memorial Hospital
Harvey, Illinois, 60426
Loyola University Medical Center
Maywood, Illinois, 60153
Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
St. John's Medical Center
Anderson, Indiana, 46016
Bloomington Hospital
Bloomington, Indiana, 47402
Clarian Health Partners Inc.
Indianapolis, Indiana, 46206-1367
Regional Cancer Center
Indianapolis, Indiana, 46219
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
Ball Memorial Hospital
Muncie, Indiana, 47303-3499
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, 52001
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0293
Central Baptist Hospital
Lexington, Kentucky, 40503
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Louisville Radiation Oncology
Louisville, Kentucky, 40215
Merle M. Mahr Cancer Center
Madisonville, Kentucky, 42431
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
CCOP - Ochsner
New Orleans, Louisiana, 70121
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
Tulane University School of Medicine
New Orleans, Louisiana, 70112-2699
Maine Medical Center
Portland, Maine, 04102
Anne Arundel Oncology Center
Annapolis, Maryland, 21401
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, 21204
Harbor Hospital Center
Baltimore, Maryland, 21215-1290
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Peninsula Regional Medical Center
Salisbury, Maryland, 21801
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Cape Cod Hospital
Hyannis, Massachusetts, 02601
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Henry Ford Hospital
Detroit, Michigan, 48202
Hurley Medical Center
Flint, Michigan, 48503
McLaren Regional Cancer Center
Flint, Michigan, 48532-3685
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
Marquette General Hospital
Marquette, Michigan, 49855
MidMichigan Medical Center - Midland
Midland, Michigan, 48670
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
William Beaumont Hospital
Royal Oak, Michigan, 48073
William Beaumont Hospital - Troy
Troy, Michigan, 48098
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
CCOP - Kansas City
Kansas City, Missouri, 64131
Cancer Research for the Ozarks
Springfield, Missouri, 65807
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
Mallinckrodt Institute of Radiology
St Louis, Missouri, 63108
St. Louis University Health Sciences Center
St Louis, Missouri, 63110-0250
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
Methodist Cancer Center - Omaha
Omaha, Nebraska, 68114
Nebraska Health System
Omaha, Nebraska, 68198-7460
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
Elliot Regional Cancer Center
Manchester, New Hampshire, 03103
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07019
John F. Kennedy Medical Center
Edison, New Jersey, 08818
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, 07201
Monmouth Medical Center
Long Branch, New Jersey, 07740-6395
South Jersey Regional Cancer Center
Millville, New Jersey, 08332
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060
Cancer Institute of New Jersey
New Brunswick, New Jersey, 38103-2807
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Atlantic City Medical Center
Pomona, New Jersey, 08240
Valley Hospital
Ridgewood, New Jersey, 07450
Community Medical Center
Toms River, New Jersey, 08755
St. Francis Medical Center
Trenton, New Jersey, 08629
Associated Radiologists, P.A.
Warren Township, New Jersey, 07059
Radiation Oncology Associates of Albuquerque
Albuquerque, New Mexico, 87109
Cancer Center of Albany Medical Center
Albany, New York, 12208
New York Methodist Hospital
Brooklyn, New York, 11215
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Finger Lakes Radiation Oncology Center
Clifton Springs, New York, 14432
CCOP - North Shore University Hospital
Manhasset, New York, 11030
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, 12901
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601
James P. Wilmot Cancer Center
Rochester, New York, 14642
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
Riverhill Radiation Oncology
Yonkers, New York, 10701
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
Northeast Medical Center
Concord, North Carolina, 28025
East Carolina University School of Medicine
Greenville, North Carolina, 27858-4354
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082
Trinity Cancer Care Center
Minot, North Dakota, 58701
Akron City Hospital
Akron, Ohio, 44304
Akron General Medical Center
Akron, Ohio, 44302
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45267-0502
Christ Hospital
Cincinnati, Ohio, 45219
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
CCOP - Columbus
Columbus, Ohio, 43206
CCOP - Dayton
Kettering, Ohio, 45429
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
St. Anthony Hospital
Oklahoma City, Oklahoma, 73101
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
CCOP - Oklahoma
Tulsa, Oklahoma, 74136
St. John Health System
Tulsa, Oklahoma, 74104
CCOP - Columbia River Program
Portland, Oregon, 97225
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, 18015
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001
Mercy Fitzgerald Hospital
Darby, Pennsylvania, 19023
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
Pocono Cancer Center
East Stroudsburg, Pennsylvania, 18301
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141-3098
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
Veterans Affairs Medical Center - Philadelphia
Philadelphia, Pennsylvania, 19104
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15219
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, 18501
Wilkes Barre General Hospital
Wilkes-Barre, Pennsylvania, 18764
York Hospital
York, Pennsylvania, 17315
Roger Williams Medical Center/BUSM
Providence, Rhode Island, 02908-4735
CCOP - Greenville
Greenville, South Carolina, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301-3956
University of Tennessee Cancer Institute
Memphis, Tennessee, 38103
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-5671
Harrington Cancer Center
Amarillo, Texas, 79106
University of Texas Medical Branch
Galveston, Texas, 77555-0209
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236-5300
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410-1894
Bayshore Medical Center
Pasadena, Texas, 77504
Latter Day Saints Hospital
Salt Lake City, Utah, 84143
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
Dixie Regional Medical Center
St. George, Utah, 84770
Vermont Cancer Center
Burlington, Vermont, 05401
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
RMH Regional Cancer Center
Harrisonburg, Virginia, 22801
Naval Medical Center, Portsmouth
Portsmouth, Virginia, 23708-2197
Bon-Secours - St. Mary's Hospital
Richmond, Virginia, 23226
Massey Cancer Center
Richmond, Virginia, 23298-0037
Virginia Mason Medical Center
Seattle, Washington, 98111
Deaconess Medical Center
Spokane, Washington, 99210-0248
Yakima Valley Memorial Hospital
Yakima, Washington, 98902
Schiffler Cancer Center
Wheeling, West Virginia, 26003
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
St. Vincent Hospital
Green Bay, Wisconsin, 54307-3508
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, 54601
Southern Wisconsin Radiotherapy Center
Madison, Wisconsin, 53713
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
Marshfield Clinic
Marshfield, Wisconsin, 54449
Community Memorial Hospital
Menomonee Falls, Wisconsin, 53051
Columbia Hospital
Milwaukee, Wisconsin, 53211
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
All Saints Cancer Center
Racine, Wisconsin, 53405
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188

Fuente Oficial

Ver en ClinicalTrials.gov