- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00056030
Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases From Colorectal Cancer
A Phase II Study Of Oxaliplatin (OXAL), 5-Fluorouracil (5-FU), Leucovorin (CF), and Cetuximab (C225) For Patients With Unresectable Hepatic Metastases From Metastatic Adenocarcinoma Of The Colon Or Rectum
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with cetuximab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with cetuximab works in treating patients with unresectable liver metastases from colorectal cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Determine the surgical resectability rate of patients with unresectable hepatic metastases secondary to metastatic colorectal adenocarcinoma treated with oxaliplatin, fluorouracil, leucovorin calcium, and cetuximab.
- Determine the response rate and overall survival of patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1 and 8. Patients also receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity, for a minimum of 12 courses or until deemed to have resectable disease.
Quality of life is assessed at baseline and prior to each treatment course.
Patients are followed every 3 months for 1 year and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 67-73 patients will be accrued for this study within 4 years.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
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Alabama
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Mobile, Alabama, Estados Unidos, 36652-2144
- Mobile Infirmary Medical Center
-
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85259-5499
- Mayo Clinic Scottsdale
-
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Florida
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Jacksonville, Florida, Estados Unidos, 32224
- Mayo Clinic - Jacksonville
-
-
Illinois
-
Aurora, Illinois, Estados Unidos, 60507
- Rush-Copley Cancer Care Center
-
Bloomington, Illinois, Estados Unidos, 61701
- St. Joseph Medical Center
-
Canton, Illinois, Estados Unidos, 61520
- Graham Hospital
-
Carthage, Illinois, Estados Unidos, 62321
- Memorial Hospital
-
Eureka, Illinois, Estados Unidos, 61530
- Eureka Community Hospital
-
Galesburg, Illinois, Estados Unidos, 61401
- Galesburg Cottage Hospital
-
Galesburg, Illinois, Estados Unidos, 61401
- Galesburg Clinic, PC
-
Havana, Illinois, Estados Unidos, 62644
- Mason District Hospital
-
Hopedale, Illinois, Estados Unidos, 61747
- Hopedale Medical Complex
-
Joliet, Illinois, Estados Unidos, 60435
- Joliet Oncology-Hematology Associates, Limited - West
-
Kewanee, Illinois, Estados Unidos, 61443
- Kewanee Hospital
-
Macomb, Illinois, Estados Unidos, 61455
- Mcdonough District Hospital
-
Moline, Illinois, Estados Unidos, 61265
-
Moline, Illinois, Estados Unidos, 61265
- Trinity Medical Center - East
-
Normal, Illinois, Estados Unidos, 61761
- Bromenn Regional Medical Center
-
Normal, Illinois, Estados Unidos, 61761
- Community Cancer Center
-
Ottawa, Illinois, Estados Unidos, 61350
- Community Hospital of Ottawa
-
Ottawa, Illinois, Estados Unidos, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
-
Pekin, Illinois, Estados Unidos, 61554
- Cancer Treatment Center at Pekin Hospital
-
Peoria, Illinois, Estados Unidos, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, Estados Unidos, 61614
- Proctor Hospital
-
Peoria, Illinois, Estados Unidos, 61637
- OSF St. Francis Medical Center
-
Peoria, Illinois, Estados Unidos, 61615
- CCOP - Illinois Oncology Research Association
-
Peoria, Illinois, Estados Unidos, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
-
Peru, Illinois, Estados Unidos, 61354
- Illinois Valley Community Hospital
-
Princeton, Illinois, Estados Unidos, 61356
- Perry Memorial Hospital
-
Spring Valley, Illinois, Estados Unidos, 61362
- St. Margaret's Hospital
-
Urbana, Illinois, Estados Unidos, 61801
- Carle Cancer Center at Carle Foundation Hospital
-
Urbana, Illinois, Estados Unidos, 61801
- CCOP - Carle Cancer Center
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Indiana
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Beech Grove, Indiana, Estados Unidos, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Michigan City, Indiana, Estados Unidos, 46360
- Saint Anthony Memorial Health Centers
-
Richmond, Indiana, Estados Unidos, 47374
- Reid Hospital & Health Care Services, Incorporated
-
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Iowa
-
Ames, Iowa, Estados Unidos, 50010
- McFarland Clinic, PC
-
Bettendorf, Iowa, Estados Unidos, 52722
-
Cedar Rapids, Iowa, Estados Unidos, 52403
- Cedar Rapids Oncology Associates
-
Des Moines, Iowa, Estados Unidos, 50309
- CCOP - Iowa Oncology Research Association
-
Des Moines, Iowa, Estados Unidos, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
-
Des Moines, Iowa, Estados Unidos, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
-
Des Moines, Iowa, Estados Unidos, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
-
Des Moines, Iowa, Estados Unidos, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Estados Unidos, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
-
Des Moines, Iowa, Estados Unidos, 50307
- Mercy Capitol Hospital
-
Mason City, Iowa, Estados Unidos, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
-
Sioux City, Iowa, Estados Unidos, 51101
- Siouxland Hematology-Oncology Associates, LLP
-
Sioux City, Iowa, Estados Unidos, 51104
- St. Luke's Regional Medical Center
-
Sioux City, Iowa, Estados Unidos, 51104
- Mercy Medical Center - Sioux City
-
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Kansas
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Chanute, Kansas, Estados Unidos, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Estados Unidos, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Estados Unidos, 67042
- Cancer Center of Kansas, PA - El Dorado
-
Kingman, Kansas, Estados Unidos, 67068
- Cancer Center of Kansas, PA - Kingman
-
Liberal, Kansas, Estados Unidos, 67901
- Southwest Medical Center
-
Newton, Kansas, Estados Unidos, 67114
- Cancer Center of Kansas, PA - Newton
-
Parsons, Kansas, Estados Unidos, 67357
- Cancer Center of Kansas, PA - Parsons
-
Pratt, Kansas, Estados Unidos, 67124
- Cancer Center of Kansas, PA - Pratt
-
Salina, Kansas, Estados Unidos, 67042
- Cancer Center of Kansas, PA - Salina
-
Wellington, Kansas, Estados Unidos, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Estados Unidos, 67203
- Associates in Womens Health, PA - North Review
-
Wichita, Kansas, Estados Unidos, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
-
Wichita, Kansas, Estados Unidos, 67214
- Cancer Center of Kansas, PA - Wichita
-
Wichita, Kansas, Estados Unidos, 67214
- CCOP - Wichita
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Wichita, Kansas, Estados Unidos, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Winfield, Kansas, Estados Unidos, 67156
- Cancer Center of Kansas, PA - Winfield
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Michigan
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Adrian, Michigan, Estados Unidos, 49221
- Hickman Cancer Center at Bixby Medical Center
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Escanaba, Michigan, Estados Unidos, 49431
- Green Bay Oncology, Limited - Escanaba
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Iron Mountain, Michigan, Estados Unidos, 49801
- Dickinson County Healthcare System
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Lambertville, Michigan, Estados Unidos, 48144
- Haematology-Oncology Associates of Ohio and Michigan, PC
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Monroe, Michigan, Estados Unidos, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, Estados Unidos, 48162
- Mercy Memorial Hospital - Monroe
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Minnesota
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Alexandria, Minnesota, Estados Unidos, 56308
-
Bemidji, Minnesota, Estados Unidos, 56601
- MeritCare Bemidji
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Burnsville, Minnesota, Estados Unidos, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Estados Unidos, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Estados Unidos, 55805
- CCOP - Duluth
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Duluth, Minnesota, Estados Unidos, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Estados Unidos, 55805
- Miller - Dwan Medical Center
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Edina, Minnesota, Estados Unidos, 55435
- Fairview Southdale Hospital
-
Fergus Falls, Minnesota, Estados Unidos, 56537
-
Fridley, Minnesota, Estados Unidos, 55432
- Mercy and Unity Cancer Center at Unity Hospital
-
Hutchinson, Minnesota, Estados Unidos, 55350
- Hutchinson Area Health Care
-
Lichfield, Minnesota, Estados Unidos, 55355
- Meeker County Memorial Hospital
-
Maplewood, Minnesota, Estados Unidos, 55109
- Minnesota Oncology Hematology, PA - Maplewood
-
Maplewood, Minnesota, Estados Unidos, 55109
- HealthEast Cancer Care at St. John's Hospital
-
Minneapolis, Minnesota, Estados Unidos, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Minneapolis, Minnesota, Estados Unidos, 55415
- Hennepin County Medical Center - Minneapolis
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Montevideo, Minnesota, Estados Unidos, 56265
- Chippewa County - Montevideo Hospital and Medical Center
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Robbinsdale, Minnesota, Estados Unidos, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Estados Unidos, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, Estados Unidos, 55416
- CCOP - Metro-Minnesota
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Shakopee, Minnesota, Estados Unidos, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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St Paul, Minnesota, Estados Unidos, 55102
- HealthEast Cancer Care at St. Joseph's Hospital
-
St. Cloud, Minnesota, Estados Unidos, 56303
- CentraCare Clinic - River Campus
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St. Louis Park, Minnesota, Estados Unidos, 55416
- Park Nicollet Cancer Center
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St. Paul, Minnesota, Estados Unidos, 55102
- United Hospital
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St. Paul, Minnesota, Estados Unidos, 55101
- Regions Hospital Cancer Care Center
-
Waconia, Minnesota, Estados Unidos, 55387
- Ridgeview Medical Center
-
Woodbury, Minnesota, Estados Unidos, 55125
- Minnesota Oncology Hematology, PA - Woodbury
-
Woodbury, Minnesota, Estados Unidos, 55125
- HealthEast Cancer Care at Woodwinds Health Campus
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Montana
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Great Falls, Montana, Estados Unidos, 59405-5309
- Big Sky Oncology
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68106
- CCOP - Missouri Valley Cancer Consortium
-
Omaha, Nebraska, Estados Unidos, 68122
- Immanuel Medical Center
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Omaha, Nebraska, Estados Unidos, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
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Omaha, Nebraska, Estados Unidos, 68131-2197
- Creighton University Medical Center
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North Carolina
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Rutherfordton, North Carolina, Estados Unidos, 28139
- Rutherford Hospital
-
-
North Dakota
-
Bismarck, North Dakota, Estados Unidos, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Estados Unidos, 58501
- Medcenter One Hospital Cancer Care Center
-
Bismarck, North Dakota, Estados Unidos, 58501
- Mid Dakota Clinic, PC
-
Bismarck, North Dakota, Estados Unidos, 58502
- St. Alexius Medical Center Cancer Center
-
Fargo, North Dakota, Estados Unidos, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, Estados Unidos, 58122
- MeritCare Broadway
-
Grand Forks, North Dakota, Estados Unidos, 58201
- Altru Cancer Center at Altru Hospital
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Ohio
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Bowling Green, Ohio, Estados Unidos, 43402
- Wood County Oncology Center
-
Dayton, Ohio, Estados Unidos, 45428
- Veterans Affairs Medical Center - Dayton
-
Dayton, Ohio, Estados Unidos, 45405
- Grandview Hospital
-
Dayton, Ohio, Estados Unidos, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, Estados Unidos, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
-
Dayton, Ohio, Estados Unidos, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, Estados Unidos, 45429
- CCOP - Dayton
-
Findlay, Ohio, Estados Unidos, 45840
- Blanchard Valley Medical Associates
-
Fremont, Ohio, Estados Unidos, 43420
- Fremont Memorial Hospital
-
Kettering, Ohio, Estados Unidos, 45429
- Charles F. Kettering Memorial Hospital
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Lima, Ohio, Estados Unidos, 45804
- Lima Memorial Hospital
-
Maumee, Ohio, Estados Unidos, 43537
- Northwest Ohio Oncology Center
-
Maumee, Ohio, Estados Unidos, 43537
- St. Luke's Hospital
-
Middletown, Ohio, Estados Unidos, 45044
- Middletown Regional Hospital
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Oregon, Ohio, Estados Unidos, 43616
- St. Charles Mercy Hospital
-
Oregon, Ohio, Estados Unidos, 43616
- Toledo Clinic - Oregon
-
Sandusky, Ohio, Estados Unidos, 44870
- Firelands Regional Medical Center
-
Sandusky, Ohio, Estados Unidos, 44870
- North Coast Cancer Care, Incorporated
-
Sylvania, Ohio, Estados Unidos, 43560
- Flower Hospital Cancer Center
-
Tiffin, Ohio, Estados Unidos, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, Estados Unidos, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, Estados Unidos, 43606
- Toledo Hospital
-
Toledo, Ohio, Estados Unidos, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, Estados Unidos, 43617
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, Estados Unidos, 43623
- Toledo Clinic, Incorporated - Main Clinic
-
Troy, Ohio, Estados Unidos, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Wauseon, Ohio, Estados Unidos, 43567
- Fulton County Health Center
-
Xenia, Ohio, Estados Unidos, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
-
Pennsylvania
-
Allentown, Pennsylvania, Estados Unidos, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
-
Danville, Pennsylvania, Estados Unidos, 17822-0001
- Geisinger Medical Center
-
Pittsburgh, Pennsylvania, Estados Unidos, 15212
- Allegheny Cancer Center at Allegheny General Hospital
-
Sayre, Pennsylvania, Estados Unidos, 18840
- Guthrie Cancer Center at Guthrie Clinic Sayre
-
State College, Pennsylvania, Estados Unidos, 16801
- Geisinger Medical Group - Scenery Park
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Wilkes-Barre, Pennsylvania, Estados Unidos, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
-
-
South Carolina
-
Anderson, South Carolina, Estados Unidos, 29621
- AnMed Cancer Center
-
Spartanburg, South Carolina, Estados Unidos, 29303
- CCOP - Upstate Carolina
-
Spartanburg, South Carolina, Estados Unidos, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
-
-
South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, Estados Unidos, 57105
- Medical X-Ray Center, PC
-
Sioux Falls, South Dakota, Estados Unidos, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
-
-
Virginia
-
Fredericksburg, Virginia, Estados Unidos, 22401
- Fredericksburg Oncology, Incorporated
-
-
Wisconsin
-
Green Bay, Wisconsin, Estados Unidos, 54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Estados Unidos, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, Estados Unidos, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay, Wisconsin, Estados Unidos, 54303
- St. Mary's Hospital Medical Center - Green Bay
-
Marinette, Wisconsin, Estados Unidos, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
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Oconto Falls, Wisconsin, Estados Unidos, 54154
- Green Bay Oncology, Limited - Oconto Falls
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Sturgeon Bay, Wisconsin, Estados Unidos, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
History of completely resected primary adenocarcinoma of the colon or rectum
- No gross or microscopic evidence of residual disease
Liver metastases, meeting 1 of the following criteria:
- Not optimally resectable
- Requires resection of all 3 major hepatic veins, the portal vein bifurcation, or the retrohepatic vena cava
- Includes the main right or main left portal vein and the main hepatic vein of the opposite lobe
- Requires more than a right or left trisegmentectomy
- At least 6 metastatic lesions distributed diffusely in both lobes of the liver
Measurable disease
- At least 1 measurable lesion ≥ 20 mm
- No evidence of extrahepatic metastases by physical examination or x-ray
- No previously resected extrahepatic metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Hemoglobin ≥ 9 g/dL
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- AST ≤ 3 times upper limit of normal (ULN)
- Bilirubin ≤ ULN
- No preexisting chronic hepatic disease (e.g., chronic active hepatitis, cirrhosis) that would preclude surgical resection of metastases
Renal
- Creatinine ≤ 1.5 times ULN
Cardiovascular
- No myocardial infarction within the past 6 months
- No clinical evidence of congestive heart failure
- No New York Heart Association class III-IV heart disease
- No significant cardiac disease
- No uncontrolled hypertension
- No unstable angina
- No congestive heart failure
- No uncontrolled arrhythmias
Gastrointestinal
- Adequate oral nutrition with estimated caloric intake of ≥ 1,500 calories/day
- No severe anorexia or frequent nausea and/or vomiting
- No history of gastrointestinal bleeding that has not been appropriately addressed
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to tolerate major surgery
- No prior allergic reaction or known sensitivity to chimerized or murine monoclonal antibody therapy
- No documented presence of human anti-mouse antibodies
- No known allergy to other platinum compounds
- No other malignancy within the past 5 years except basal cell or squamous cell skin cancer, carcinoma in situ, or tumors associated with less than 10% probability of death within 5 years of diagnosis
- No preexisting neuropathy ≥ grade 2
- No symptomatic pulmonary fibrosis or interstitial pneumonitis
- No uncontrolled bacterial or viral infection
- HIV negative
- No fungal infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No colony-stimulating factors within 24 hours of day 1 of each course
- No concurrent immunotherapy
Chemotherapy
- At least 1 year since prior adjuvant systemic fluorouracil with or without levamisole or with or without leucovorin calcium
- No prior oxaliplatin
- No prior systemic chemotherapy for metastatic disease
- No prior chemoembolization for metastatic disease
- No prior hepatic artery infusion chemotherapy for metastatic disease
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- At least 12 months since prior adjuvant radiotherapy
- Prior radiofrequency ablation allowed
- No prior radiotherapy to the liver
- No prior radiotherapy to more than 25% of the bone marrow
- No concurrent radiotherapy
Surgery
- See Disease Characteristics
- More than 21 days since prior abdominal exploration (with or without intestinal resection)
Other
- No prior anti-EGFR-directed therapy
- Prior cryotherapy allowed
- No oral cryotherapy on day 1 of each course
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: cetuximab + oxaliplatin + leucovorin + fluorouracil
Patients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1 and 8. Patients also receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity, for a minimum of 12 courses or until deemed to have resectable disease. Quality of life is assessed at baseline and prior to each treatment course. Patients are followed every 3 months for 1 year and then every 6 months for 3 years. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Surgical resectability rate as assessed by surgical resection of liver metastases
Periodo de tiempo: Up to 4 years
|
Up to 4 years
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Sobrevivencia promedio
Periodo de tiempo: Hasta 4 años
|
Hasta 4 años
|
Response rate as measured by RECIST criteria every 6 weeks
Periodo de tiempo: Up to 4 years
|
Up to 4 years
|
Quality of life as assessed by UNISCALE and Symptom Distress Scale every 6 weeks
Periodo de tiempo: Up to 4 years
|
Up to 4 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Procesos Patológicos
- Neoplasias
- Neoplasias por sitio
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Colon
- Enfermedades intestinales
- Neoplasias Intestinales
- Enfermedades Rectales
- Procesos Neoplásicos
- Neoplasias colorrectales
- Metástasis de neoplasias
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes Protectores
- Agentes antineoplásicos inmunológicos
- Micronutrientes
- Vitaminas
- Hormonas y agentes reguladores del calcio
- Antídotos
- Complejo de vitamina B
- Fluorouracilo
- Oxaliplatino
- Leucovorina
- Calcio
- Levoleucovorina
- Cetuximab
Otros números de identificación del estudio
- NCCTG-N014A
- NCI-2012-02521 (Identificador de registro: CTRP (Clinical Trials Reporting System))
- CDR0000271923 (Identificador de registro: PDQ (Physician Data Query))
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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