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NCT00023751

Cirugía, con o sin quimioterapia y radioterapia, en el tratamiento de pacientes con cáncer de recto en estadio I.

Archived Fase 2

Descripción

JUSTIFICACIÓN: Los fármacos utilizados en la quimioterapia emplean diferentes mecanismos para impedir que las células tumorales se dividan, de modo que dejen de crecer o mueran. La radioterapia utiliza rayos X de alta energía para dañar las células tumorales. La combinación de cirugía con quimioterapia y radioterapia puede destruir más células tumorales y prevenir la recurrencia del cáncer.

OBJETIVO: Ensayo de fase II para estudiar la eficacia de la cirugía, con o sin quimioterapia y radioterapia, en el tratamiento de pacientes con cáncer de recto en estadio I.

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 del recto confirmado histológicamente
  • T1 o T2 según los exámenes físicos y endoscópicos
  • Sin lesiones T3 según el examen clínico o radiológico
  • Se permiten adenomas vellosos o carcinoma in situ sin confirmación histológica si existe una apariencia clínica de cáncer
  • Sin enfermedad multifocal en el recto en el momento del diagnóstico inicial
  • Sin cáncer rectal o anal no adenocarcinoma
  • Menos de 4 cm en el diámetro máximo
  • Menos del 40% de la circunferencia de la pared rectal afectada
  • El margen proximal no debe ser mayor de 8 cm desde la línea dentada
  • Sin fijación tumoral a los tejidos perirrectales, independientemente del tamaño
  • Sin ganglios linfáticos regionales malignos ni metástasis a distancia según el examen clínico o la imagen radiográfica
  • Sin ganglios linfáticos perirrectales palpables o ganglios mayores de 1 cm
  • Sin evidencia de ganglios linfáticos perirrectales malignos mediante ecografía endorrectal o resonancia magnética endorrectal

CARACTERÍSTICAS DEL PACIENTE:

Edad:

  • 18 años o más

Estado funcional:

  • CTC 0-2

Esperanza de vida:

  • No especificado

Hematopoyético:

  • Conteo de glóbulos blancos de al menos 4.000/mm³
  • Conteo de plaquetas de al menos 100.000/mm³

Hepático:

  • Bilirrubina menor de 1,5 veces el valor normal

Renal:

  • Creatinina menor de 1,8 mg/dL

Otros:

  • No estar embarazada ni en período de lactancia
  • Prueba de embarazo negativa
  • Los pacientes fértiles deben utilizar métodos anticonceptivos eficaces
  • Sin otra neoplasia previa o concurrente en los últimos 5 años, excepto cáncer de piel no melanoma inactivo o carcinoma in situ del cuello uterino

TERAPIA PREVIA O CONCURRENTE:

Terapia biológica:

  • No especificado

Quimioterapia:

  • Sin quimioterapia previa

Terapia endocrina:

  • No especificado

Radioterapia:

  • Sin radioterapia previa

Cirugía:

  • Sin cirugía previa para el cáncer de recto, incluidos intentos previos de resección quirúrgica transanal o transcoccígea con márgenes poco claros o positivos
  • Se permite una incisión o biopsia operatoria previa o una resección colonoscópica

Información del Ensayo

NCT00023751
Archived
Fase 2
320 participantes
Jul 2001

Ubicaciones180

Canada (1)
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Puerto Rico (1)
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, 00936-5067
United States (178)
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36207
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, 85012
Arizona Cancer Center
Tucson, Arizona, 85724
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
Chao Family Comprehensive Cancer Center
Orange, California, 92868
University of California Davis Cancer Center
Sacramento, California, 95817
Veterans Affairs Medical Center - San Diego
San Diego, California, 92161
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
David Grant Medical Center
Travis Air Force Base, California, 94535
University of Colorado Cancer Center
Denver, Colorado, 80010
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, 20060
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, 20422
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
Broward General Medical Center
Fort Lauderdale, Florida, 33316
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, 33021
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140
Florida Hospital Cancer Institute
Orlando, Florida, 32804
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
West Palm Beach, Florida, 33401
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813-2424
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-W227
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
CCOP - Central Illinois
Decatur, Illinois, 62526
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
Loyola University Medical Center
Maywood, Illinois, 60153-5500
West Suburban Center for Cancer Care
River Forest, Illinois, 60305
Saint Anthony Medical Center
Rockford, Illinois, 61108
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, 46885-5099
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, 52722
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
University of Kansas Medical Center
Kansas City, Kansas, 66160-7353
CCOP - Wichita
Wichita, Kansas, 67214-3882
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40502-2236
Baptist Hospital East - Louisville
Louisville, Kentucky, 40207
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
Tulane University School of Medicine
New Orleans, Louisiana, 70112
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, 21201
Boston Medical Center
Boston, Massachusetts, 02118
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0912
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Henry Ford Hospital
Detroit, Michigan, 48202
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, 49085
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, 39534-2576
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
CCOP - Kansas City
Kansas City, Missouri, 64131
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
Barnes-Jewish Hospital
St Louis, Missouri, 63110
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141
Missouri Baptist Cancer Center
St Louis, Missouri, 63131
St. Louis University Health Sciences Center
St Louis, Missouri, 63110
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, 89106
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
Cooper University Hospital
Camden, New Jersey, 08103
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
Elmhurst Hospital Center
Elmhurst, New York, 11373
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
CCOP - North Shore University Hospital
Manhasset, New York, 11030
North Shore University Hospital
Manhasset, New York, 11030
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Mount Sinai Medical Center, NY
New York, New York, 10029
Weill Medical College of Cornell University
New York, New York, 10021
James P. Wilmot Cancer Center
Rochester, New York, 14642
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
State University of New York - Upstate Medical University
Syracuse, New York, 13210
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, 28805
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
NorthEast Oncology Associates
Concord, North Carolina, 28025
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
Cape Fear Valley Health System
Fayetteville, North Carolina, 28302-2000
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, 28503-1678
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402-9025
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102
Barrett Cancer Center
Cincinnati, Ohio, 45267-0501
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195-9001
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
CCOP - Columbus
Columbus, Ohio, 43206
CCOP - Dayton
Dayton, Ohio, 45429
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
Oregon Cancer Institute
Portland, Oregon, 97201-3098
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
Lifespan: The Miriam Hospital
Providence, Rhode Island, 02906
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, 29401-5799
CCOP - Greenville
Greenville, South Carolina, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
Danville Radiation Therapy Center
Memphis, Tennessee, 38104
University of Tennessee Cancer Institute
Memphis, Tennessee, 38103
Harrington Cancer Center
Amarillo, Texas, 79106
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas, 79106
Veterans Affairs Medical Center - Dallas
Dallas, Texas, 75216
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200
University of Texas Medical Branch
Galveston, Texas, 77555-0565
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4095
Veterans Affairs Medical Center - Houston
Houston, Texas, 77030
Texas Tech University Health Science Center
Lubbock, Texas, 79415
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78229
CCOP - Scott and White Hospital
Temple, Texas, 76508
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
Green Mountain Oncology Group
Bennington, Vermont, 05201
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, 05401
Vermont Cancer Center
Burlington, Vermont, 05401-3498
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
Martha Jefferson Hospital
Charlottesville, Virginia, 22901
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, 23502
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
CCOP - Northwest
Tacoma, Washington, 98405-0986
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
St. Mary's Medical Center
Huntington, West Virginia, 25701
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, 54501

Fuente Oficial

Ver en ClinicalTrials.gov