Docetaxel, Oxaliplatin, Capecitabine, Fluorouracil, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
2. března 2018 aktualizováno: Alliance for Clinical Trials in Oncology
Randomized Phase II Trial of Extended Neoadjuvant Therapy for Locally Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia
This randomized phase II trial studies how well docetaxel, oxaliplatin, capecitabine, fluorouracil, and radiation therapy works compared with fluorouracil when given together with oxaliplatin and radiation therapy in treating patients with cancer of the esophagus or gastroesophageal junction that has spread from where it started to nearby tissue or lymph nodes.
Drugs used in chemotherapy, such as docetaxel, oxaliplatin, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from dividing.
Radiation therapy uses high-energy x-rays to kill tumor cells.
Giving more than one drug (combination chemotherapy) together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Přehled studie
Postavení
Dokončeno
Detailní popis
PRIMARY OBJECTIVES:
I. To assess and compare the pathologic complete response (PCR) rate of patients in Arm A receiving the sequence docetaxel, oxaliplatin, and capecitabine (DOC) followed by 5-fluorouracil (5-FU), oxaliplatin, and radiation therapy (RT) with patients in Arm B receiving only 5-FU, oxaliplatin and RT in patients with potentially resectable adenocarcinoma (ACA) of the esophagus, gastroesophageal junction (GEJ), or gastric cardia.
SECONDARY OBJECTIVES:
I. To assess the adverse event (AE) profile and safety of the proposed treatment in this population.
II. To assess and compare the overall survival (OS) between treatment arms. III. To assess and compare the disease-free survival between treatment arms. IV. To assess and compare the clinical tumor response rate of the proposed regiments when administered before surgery between treatment arms.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive docetaxel intravenously (IV) over 1 hour and oxaliplatin IV over 2 hours on day 1. Patients also receive capecitabine orally (PO) twice daily (BID) on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive fluorouracil* IV continuously on days 1-5 and oxaliplatin IV over 2 hours on days 1, 15, and 29. Patients also undergo radiotherapy** 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiotherapy, patients undergo surgery.
ARM II: Patients receive fluorouracil IV continuously on days 1-5 and oxaliplatin IV over 2 hours on days 1, 15, and 29. Patients also undergo radiotherapy and then surgery as in Arm I.
- NOTE: * Fluorouracil continuous IV infusion begins within 24 hours of radiotherapy and ends within 24 hours of radiotherapy completion.
- NOTE: ** Radiotherapy should begin within 2-6 weeks after completion of 2 courses of docetaxel, oxaliplatin, and capecitabine.
After completion of study treatment, patients are followed up every 3 months for 2 years.
Typ studie
Intervenční
Zápis (Aktuální)
73
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
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Arizona
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Scottsdale, Arizona, Spojené státy, 85259-5499
- Mayo Clinic Scottsdale
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Colorado
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Fort Collins, Colorado, Spojené státy, 80524
- Poudre Valley Hospital
-
Fort Collins, Colorado, Spojené státy, 80528
- Front Range Cancer Specialists
-
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Connecticut
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Hartford, Connecticut, Spojené státy, 06105
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
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Florida
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Jacksonville, Florida, Spojené státy, 32224
- Mayo Clinic - Jacksonville
-
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Idaho
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Boise, Idaho, Spojené státy, 83706
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
-
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Illinois
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Bloomington, Illinois, Spojené státy, 61701
- Illinois CancerCare - Bloomington
-
Bloomington, Illinois, Spojené státy, 61701
- St. Joseph Medical Center
-
Canton, Illinois, Spojené státy, 61520
- Illinois CancerCare - Canton
-
Canton, Illinois, Spojené státy, 61520
- Graham Hospital
-
Carthage, Illinois, Spojené státy, 62321
- Illinois CancerCare - Carthage
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Eureka, Illinois, Spojené státy, 61530
- Illinois CancerCare - Eureka
-
Eureka, Illinois, Spojené státy, 61530
- Eureka Community Hospital
-
Galesburg, Illinois, Spojené státy, 61401
- Illinois CancerCare - Galesburg
-
Galesburg, Illinois, Spojené státy, 61401
- Galesburg Clinic, PC
-
Havana, Illinois, Spojené státy, 62644
- Mason District Hospital
-
Havana, Illinois, Spojené státy, 62644
- Illinois CancerCare - Havana
-
Kewanee, Illinois, Spojené státy, 61443
- Illinois CancerCare - Kewanee Clinic
-
Macomb, Illinois, Spojené státy, 61455
- Illinois CancerCare - Macomb
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Macomb, Illinois, Spojené státy, 61455
- Mcdonough District Hospital
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Moline, Illinois, Spojené státy, 61265
-
Moline, Illinois, Spojené státy, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
-
Monmouth, Illinois, Spojené státy, 61462
- Illinois CancerCare - Monmouth
-
Monmouth, Illinois, Spojené státy, 61462
- OSF Holy Family Medical Center
-
Normal, Illinois, Spojené státy, 61761
- Bromenn Regional Medical Center
-
Normal, Illinois, Spojené státy, 61761
- Community Cancer Center
-
Normal, Illinois, Spojené státy, 61761
- Illinois CancerCare - Community Cancer Center
-
Ottawa, Illinois, Spojené státy, 61350
- Community Hospital of Ottawa
-
Ottawa, Illinois, Spojené státy, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
-
Pekin, Illinois, Spojené státy, 61554
- Cancer Treatment Center at Pekin Hospital
-
Peoria, Illinois, Spojené státy, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Spojené státy, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Spojené státy, 61615
- CCOP - Illinois Oncology Research Association
-
Peoria, Illinois, Spojené státy, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
-
Peru, Illinois, Spojené státy, 61354
- Illinois CancerCare - Peru
-
Peru, Illinois, Spojené státy, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Spojené státy, 61356
- Perry Memorial Hospital
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Princeton, Illinois, Spojené státy, 61356
- Illinois CancerCare - Princeton
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Indiana
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Beech Grove, Indiana, Spojené státy, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Richmond, Indiana, Spojené státy, 47374
- Reid Hospital & Health Care Services
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Iowa
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Bettendorf, Iowa, Spojené státy, 52722
-
Clive, Iowa, Spojené státy, 50325
- Medical Oncology and Hematology Associates - West Des Moines
-
Clive, Iowa, Spojené státy, 50325
- Mercy Cancer Center - West Lakes
-
Des Moines, Iowa, Spojené státy, 50309
- CCOP - Iowa Oncology Research Association
-
Des Moines, Iowa, Spojené státy, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
-
Des Moines, Iowa, Spojené státy, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
-
Des Moines, Iowa, Spojené státy, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
-
Des Moines, Iowa, Spojené státy, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Spojené státy, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
-
Sioux City, Iowa, Spojené státy, 51101
- Siouxland Hematology-Oncology Associates, LLP
-
Sioux City, Iowa, Spojené státy, 51102
- Mercy Medical Center - Sioux City
-
Sioux City, Iowa, Spojené státy, 51104
- St. Luke's Regional Medical Center
-
West Des Moines, Iowa, Spojené státy, 50266-7700
- Methodist West Hospital
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Kansas
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Chanute, Kansas, Spojené státy, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Spojené státy, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Spojené státy, 67042
- Cancer Center of Kansas, PA - El Dorado
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Fort Scott, Kansas, Spojené státy, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Spojené státy, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Spojené státy, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, Spojené státy, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, Spojené státy, 67901
- Cancer Center of Kansas, PA - Liberal
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Newton, Kansas, Spojené státy, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Spojené státy, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Spojené státy, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Spojené státy, 67401
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, Spojené státy, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Spojené státy, 67214
- Wesley Medical Center
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Wichita, Kansas, Spojené státy, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Spojené státy, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Spojené státy, 67214
- CCOP - Wichita
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Wichita, Kansas, Spojené státy, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, Spojené státy, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, Spojené státy, 67156
- Cancer Center of Kansas, PA - Winfield
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Spojené státy, 48106
- CCOP - Michigan Cancer Research Consortium
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Battle Creek, Michigan, Spojené státy, 49017
- Battle Creek Health System Cancer Care Center
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Dearborn, Michigan, Spojené státy, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Escanaba, Michigan, Spojené státy, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, Spojené státy, 48503
- Hurley Medical Center
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Flint, Michigan, Spojené státy, 48503
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, Spojené státy, 49503
- Butterworth Hospital at Spectrum Health
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Grand Rapids, Michigan, Spojené státy, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, Spojené státy, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Grosse Pointe Woods, Michigan, Spojené státy, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Iron Mountain, Michigan, Spojené státy, 49801
- Dickinson County Healthcare System
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Jackson, Michigan, Spojené státy, 49201
- Foote Memorial Hospital
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Lansing, Michigan, Spojené státy, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, Spojené státy, 48154
- St. Mary Mercy Hospital
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Muskegon, Michigan, Spojené státy, 49443
- Mercy General Health Partners
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Pontiac, Michigan, Spojené státy, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, Spojené státy, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Reed City, Michigan, Spojené státy, 49677
- Spectrum Health Reed City Hospital
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Saginaw, Michigan, Spojené státy, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Traverse City, Michigan, Spojené státy, 49684
- Munson Medical Center
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Warren, Michigan, Spojené státy, 48093
- St. John Macomb Hospital
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Minnesota
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Burnsville, Minnesota, Spojené státy, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Spojené státy, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Spojené státy, 55805
- CCOP - Duluth
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Duluth, Minnesota, Spojené státy, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Spojené státy, 55805
- Miller - Dwan Medical Center
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Edina, Minnesota, Spojené státy, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Spojené státy, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Spojené státy, 55350
- Hutchinson Area Health Care
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Maplewood, Minnesota, Spojené státy, 55109
- HealthEast Cancer Care at St. John's Hospital
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Maplewood, Minnesota, Spojené státy, 55109
- Minnesota Oncology - Maplewood
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Minneapolis, Minnesota, Spojené státy, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Minneapolis, Minnesota, Spojené státy, 55415
- Hennepin County Medical Center - Minneapolis
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Robbinsdale, Minnesota, Spojené státy, 55422-2900
- Humphrey Cancer Center at North Memorial Outpatient Center
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Rochester, Minnesota, Spojené státy, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, Spojené státy, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Spojené státy, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, Spojené státy, 55102
- United Hospital
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Saint Paul, Minnesota, Spojené státy, 55101
- Regions Hospital Cancer Care Center
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Shakopee, Minnesota, Spojené státy, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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Stillwater, Minnesota, Spojené státy, 55082
- Lakeview Hospital
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Waconia, Minnesota, Spojené státy, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, Spojené státy, 56201
- Willmar Cancer Center at Rice Memorial Hospital
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Woodbury, Minnesota, Spojené státy, 55125
- Minnesota Oncology - Woodbury
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Missouri
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Bolivar, Missouri, Spojené státy, 65613
- Central Care Cancer Center at Carrie J. Babb Cancer Center
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Springfield, Missouri, Spojené státy, 65802
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Spojené státy, 65804
- St. John's Regional Health Center
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Springfield, Missouri, Spojené státy, 65807
- Hulston Cancer Center at Cox Medical Center South
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Montana
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Billings, Montana, Spojené státy, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, Spojené státy, 59107-7000
- Billings Clinic - Downtown
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Billings, Montana, Spojené státy, 59102
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Bozeman, Montana, Spojené státy, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Spojené státy, 59701
- St. James Healthcare Cancer Care
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Great Falls, Montana, Spojené státy, 59405
- Great Falls Clinic - Main Facility
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Great Falls, Montana, Spojené státy, 59405
- Sletten Cancer Institute at Benefis Healthcare
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Havre, Montana, Spojené státy, 59501
- Northern Montana Hospital
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Helena, Montana, Spojené státy, 59601
- St. Peter's Hospital
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Kalispell, Montana, Spojené státy, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, Spojené státy, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, Spojené státy, 59901
- Kalispell Medical Oncology at KRMC
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Missoula, Montana, Spojené státy, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, Spojené státy, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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New Mexico
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Albuquerque, New Mexico, Spojené státy, 87131-5636
- University of New Mexico Cancer Center
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North Carolina
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Rutherfordton, North Carolina, Spojené státy, 28139
- Rutherford Hospital
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North Dakota
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Fargo, North Dakota, Spojené státy, 58103
- Dakota Cancer Institute at Dakota Clinic - South University
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Grand Forks, North Dakota, Spojené státy, 58201
- Altru Cancer Center at Altru Hospital
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Ohio
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Chillicothe, Ohio, Spojené státy, 45601
- Adena Regional Medical Center
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Columbus, Ohio, Spojené státy, 43214-3998
- Riverside Methodist Hospital Cancer Care
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Columbus, Ohio, Spojené státy, 43222
- Mount Carmel Health - West Hospital
-
Columbus, Ohio, Spojené státy, 43215
- CCOP - Columbus
-
Columbus, Ohio, Spojené státy, 43215
- Grant Medical Center Cancer Care
-
Columbus, Ohio, Spojené státy, 43228
- Doctors Hospital at Ohio Health
-
Dayton, Ohio, Spojené státy, 45405
- Grandview Hospital
-
Dayton, Ohio, Spojené státy, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, Spojené státy, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
-
Dayton, Ohio, Spojené státy, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, Spojené státy, 45420
- CCOP - Dayton
-
Delaware, Ohio, Spojené státy, 43015
- Grady Memorial Hospital
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Findlay, Ohio, Spojené státy, 45840
- Blanchard Valley Medical Associates
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Franklin, Ohio, Spojené státy, 45005-1066
- Middletown Regional Hospital
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Greenville, Ohio, Spojené státy, 45331
- Wayne Hospital
-
Kettering, Ohio, Spojené státy, 45429
- Charles F. Kettering Memorial Hospital
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Lancaster, Ohio, Spojené státy, 43130
- Fairfield Medical Center
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Marietta, Ohio, Spojené státy, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
-
Mount Vernon, Ohio, Spojené státy, 43050
- Knox Community Hospital
-
Newark, Ohio, Spojené státy, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
-
Springfield, Ohio, Spojené státy, 45505
- Community Hospital of Springfield and Clark County
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Troy, Ohio, Spojené státy, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Westerville, Ohio, Spojené státy, 43081
- Mount Carmel St. Ann's Cancer Center
-
Xenia, Ohio, Spojené státy, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
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Zanesville, Ohio, Spojené státy, 43701
- Genesis - Good Samaritan Hospital
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Pennsylvania
-
Danville, Pennsylvania, Spojené státy, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
-
Hazleton, Pennsylvania, Spojené státy, 18201
- Geisinger Hazleton Cancer Center
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State College, Pennsylvania, Spojené státy, 16801
- Geisinger Medical Group - Scenery Park
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Wilkes-Barre, Pennsylvania, Spojené státy, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
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South Carolina
-
Anderson, South Carolina, Spojené státy, 29621
- AnMed Cancer Center
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Greenville, South Carolina, Spojené státy, 29601
- Bon Secours St. Francis Health System
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Spartanburg, South Carolina, Spojené státy, 29303
- CCOP - Upstate Carolina
-
Spartanburg, South Carolina, Spojené státy, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
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South Dakota
-
Sioux Falls, South Dakota, Spojené státy, 57105
- Avera Cancer Institute
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Wisconsin
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Eau Claire, Wisconsin, Spojené státy, 54703-1510
- Midelfort Clinic - Luther
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Eau Claire, Wisconsin, Spojené státy, 54703
- Luther Midlelfort Hospital
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Green Bay, Wisconsin, Spojené státy, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, Spojené státy, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, Spojené státy, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay, Wisconsin, Spojené státy, 54303
- St. Mary's Hospital Medical Center - Green Bay
-
Manitowoc, Wisconsin, Spojené státy, 54221-1450
- Holy Family Memorial Medical Center Cancer Care Center
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Marinette, Wisconsin, Spojené státy, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
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Oconto Falls, Wisconsin, Spojené státy, 54154
- Green Bay Oncology, Limited - Oconto Falls
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Sheboygan, Wisconsin, Spojené státy, 53081
- St. Nicholas Hospital
-
Sturgeon Bay, Wisconsin, Spojené státy, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
-
Sturgeon Bay, Wisconsin, Spojené státy, 54235-1495
- Door County Cancer Center at Door County Memorial Hospital
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Wyoming
-
Sheridan, Wyoming, Spojené státy, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria
- Histological confirmation of adenocarcinoma of the esophagus, gastroesophageal (GE) junction, or gastric cardia
- Tumor must be considered surgically resectable; Note: patients with T4N0M0 tumors that are potentially resectable are also eligible
- Nodal involvement: patients with involvement of celiac nodes, (stations 15-20) are eligible if the primary lesion is mid-thoracic, distal esophagus or GE junction; patients with supraclavicular node involvement are eligible with upper thoracic esophagus primary lesions
- Capable of swallowing pills
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- Absolute neutrophil count (ANC) >= 1500
- Peripheral platelet count >= 100,000
- Hemoglobin >= 9.0 g/dL
- Total bilirubin =< 1.5 x upper normal limit (UNL)
- Serum glutamic oxaloacetic transaminase (SGOT) (alanine aminotransferase [AST]) =< 3 x UNL
- Creatinine =< 1.5 x UNL
- Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
- Provide informed written consent
- Willingness to return to NCCTG enrolling institution for follow-up
- Patient willing to provide mandatory tissue and blood samples for research purposes
- Patient willing to allow use of FDG PET/CT scans for mandatory research purposes
Exclusion Criteria
- Evidence of distant metastases
- Palpable supraclavicular nodes, biopsy-proven involvement of supraclavicular nodes, or radiographically involved supraclavicular nodes (> 1.5 cm in greatest dimension) for lesions in mid-thoracic, distal thoracic or GE junction
- T1N0M0 or T2N0M0 tumor stage
Any of the following
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Uncontrolled diabetes (i.e., will interfere with the performance of the FDG PET/CT scans)
- Receiving current treatment or prior treatment for this malignancy
- Other active malignancy 5 years prior to registration, except non-melanotic skin cancer or carcinoma-in-situ of the cervix; if there is a history of prior malignancy, patient must not be receiving other specific treatment (other than hormonal therapy) for cancer
- Prior radiation to > 30% of the marrow cavity
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Arm I (combination chemotherapy, radiation therapy, surgery)
Patients receive docetaxel IV over 1 hour and oxaliplatin IV over 2 hours on day 1.
Patients also receive capecitabine PO BID on days 1-14.
Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of the second course, patients receive fluorouracil IV continuously on days 1-5 and oxaliplatin IV over 2 hours on days 1, 15, and 29.
Patients also undergo radiotherapy 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity.
Approximately 4-12 weeks after completion of radiotherapy, patients undergo surgery.
|
Vzhledem k tomu, IV
Vzhledem k tomu, IV
Vzhledem k PO
Podstoupit operaci
Podstoupit radiační terapii
Vzhledem k tomu, IV
|
|
Aktivní komparátor: Arm II (oxaliplatin, fluorouracil, radiation, and surgery)
Patients receive fluorouracil IV continuously on days 1-5 and oxaliplatin IV over 2 hours on days 1, 15, and 29.
Patients also undergo radiotherapy and then surgery as in Arm I.
|
Vzhledem k tomu, IV
Vzhledem k tomu, IV
Podstoupit operaci
Podstoupit radiační terapii
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage of Participants With Pathologic Complete Response (PCR)
Časové okno: Up to 2 years
|
Pathologic complete response was defined as no gross or microscopic tumor identified with the surgical specimen.
All lymph nodes should be free of tumor to document a PCR.
If no gross tumor is visible, section around the area of inflammation (nodularity) should be made every 2-3 cm and specimens examined.
|
Up to 2 years
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overall Survival
Časové okno: Up to 2 years
|
Overall survival was defined as the time from randomization to the time of death from any cause.
Overall survival was censored at the date of last follow-up visit for patients who are still alive or loss of follow-up.
|
Up to 2 years
|
|
Disease-free Survival
Časové okno: Up to 2 years
|
Disease-free survival was defined as the time from randomization to the date of recurrent or death, whichever comes first.
|
Up to 2 years
|
|
Number of Participants Who Experienced a Maximum Grade of 3 or Above Adverse Event
Časové okno: Up to 2 years
|
Adverse events were assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
|
Up to 2 years
|
|
Percentage of Participants With Overall Clinical Tumor Response (CR or PR)
Časové okno: Up to 2 years
|
Overall clinical tumor response rate was defined as the percentage of evaluable participants who achieved either complete response (CR) or partial response (PR) noted on the objective status from pre-surgical staging (for arm II) or either from pre-RT or pre-surgical staging (for arm I).>
CR was defined as disappearance of all non-target lesion (TL) and normalization of tumor biomarker level, all lymph nodes (LN) must be non-pathological in size (<1 cm short axis); or disappearance of all TL and normalization of tumor biomarkers, any pathological LN (whether target or non-target) must have reduction in short axis to <1 cm; or >=30% decrease in the sum of the diameters of TL taking as reference the baseline sum of the diameters.
|
Up to 2 years
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. ledna 2010
Primární dokončení (Aktuální)
1. prosince 2013
Dokončení studie (Aktuální)
1. března 2018
Termíny zápisu do studia
První předloženo
10. července 2009
První předloženo, které splnilo kritéria kontroly kvality
10. července 2009
První zveřejněno (Odhad)
13. července 2009
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
29. března 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
2. března 2018
Naposledy ověřeno
1. března 2018
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Nemoci trávicího systému
- Novotvary podle histologického typu
- Novotvary
- Novotvary podle místa
- Karcinom
- Novotvary, žlázové a epiteliální
- Gastrointestinální novotvary
- Novotvary trávicího systému
- Gastrointestinální onemocnění
- Onemocnění žaludku
- Novotvary hlavy a krku
- Nemoci jícnu
- Novotvary žaludku
- Adenokarcinom
- Novotvary jícnu
- Fyziologické účinky léků
- Molekulární mechanismy farmakologického působení
- Antimetabolity, Antineoplastika
- Antimetabolity
- Antineoplastická činidla
- Imunosupresivní látky
- Imunologické faktory
- Tubulinové modulátory
- Antimitotické látky
- Modulátory mitózy
- Docetaxel
- Fluorouracil
- Kapecitabin
- Oxaliplatina
Další identifikační čísla studie
- NCCTG-N0849
- NCI-2011-01930 (Identifikátor registru: CTRP (Clinical Trials Reporting System))
- CDR0000646724 (Identifikátor registru: PDQ (Physician Data Query))
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .