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Docetaxel, Oxaliplatin, Capecitabine, Fluorouracil, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

2 mars 2018 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

73

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Arizona
      • Scottsdale, Arizona, Förenta staterna, 85259-5499
        • Mayo Clinic Scottsdale
    • Colorado
      • Fort Collins, Colorado, Förenta staterna, 80524
        • Poudre Valley Hospital
      • Fort Collins, Colorado, Förenta staterna, 80528
        • Front Range Cancer Specialists
    • Connecticut
      • Hartford, Connecticut, Förenta staterna, 06105
        • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
    • Florida
      • Jacksonville, Florida, Förenta staterna, 32224
        • Mayo Clinic - Jacksonville
    • Idaho
      • Boise, Idaho, Förenta staterna, 83706
        • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
    • Illinois
      • Bloomington, Illinois, Förenta staterna, 61701
        • Illinois CancerCare - Bloomington
      • Bloomington, Illinois, Förenta staterna, 61701
        • St. Joseph Medical Center
      • Canton, Illinois, Förenta staterna, 61520
        • Illinois CancerCare - Canton
      • Canton, Illinois, Förenta staterna, 61520
        • Graham Hospital
      • Carthage, Illinois, Förenta staterna, 62321
        • Illinois CancerCare - Carthage
      • Eureka, Illinois, Förenta staterna, 61530
        • Illinois CancerCare - Eureka
      • Eureka, Illinois, Förenta staterna, 61530
        • Eureka Community Hospital
      • Galesburg, Illinois, Förenta staterna, 61401
        • Illinois CancerCare - Galesburg
      • Galesburg, Illinois, Förenta staterna, 61401
        • Galesburg Clinic, PC
      • Havana, Illinois, Förenta staterna, 62644
        • Mason District Hospital
      • Havana, Illinois, Förenta staterna, 62644
        • Illinois CancerCare - Havana
      • Kewanee, Illinois, Förenta staterna, 61443
        • Illinois CancerCare - Kewanee Clinic
      • Macomb, Illinois, Förenta staterna, 61455
        • Illinois CancerCare - Macomb
      • Macomb, Illinois, Förenta staterna, 61455
        • Mcdonough District Hospital
      • Moline, Illinois, Förenta staterna, 61265
      • Moline, Illinois, Förenta staterna, 61265
        • Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
      • Monmouth, Illinois, Förenta staterna, 61462
        • Illinois CancerCare - Monmouth
      • Monmouth, Illinois, Förenta staterna, 61462
        • OSF Holy Family Medical Center
      • Normal, Illinois, Förenta staterna, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, Förenta staterna, 61761
        • Community Cancer Center
      • Normal, Illinois, Förenta staterna, 61761
        • Illinois CancerCare - Community Cancer Center
      • Ottawa, Illinois, Förenta staterna, 61350
        • Community Hospital of Ottawa
      • Ottawa, Illinois, Förenta staterna, 61350
        • Oncology Hematology Associates of Central Illinois, PC - Ottawa
      • Pekin, Illinois, Förenta staterna, 61554
        • Cancer Treatment Center at Pekin Hospital
      • Peoria, Illinois, Förenta staterna, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Förenta staterna, 61637
        • OSF St. Francis Medical Center
      • Peoria, Illinois, Förenta staterna, 61615
        • CCOP - Illinois Oncology Research Association
      • Peoria, Illinois, Förenta staterna, 61615
        • Oncology Hematology Associates of Central Illinois, PC - Peoria
      • Peru, Illinois, Förenta staterna, 61354
        • Illinois CancerCare - Peru
      • Peru, Illinois, Förenta staterna, 61354
        • Illinois Valley Community Hospital
      • Princeton, Illinois, Förenta staterna, 61356
        • Perry Memorial Hospital
      • Princeton, Illinois, Förenta staterna, 61356
        • Illinois CancerCare - Princeton
    • Indiana
      • Beech Grove, Indiana, Förenta staterna, 46107
        • St. Francis Hospital and Health Centers - Beech Grove Campus
      • Richmond, Indiana, Förenta staterna, 47374
        • Reid Hospital & Health Care Services
    • Iowa
      • Bettendorf, Iowa, Förenta staterna, 52722
      • Clive, Iowa, Förenta staterna, 50325
        • Medical Oncology and Hematology Associates - West Des Moines
      • Clive, Iowa, Förenta staterna, 50325
        • Mercy Cancer Center - West Lakes
      • Des Moines, Iowa, Förenta staterna, 50309
        • CCOP - Iowa Oncology Research Association
      • Des Moines, Iowa, Förenta staterna, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, Förenta staterna, 50309
        • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
      • Des Moines, Iowa, Förenta staterna, 50314
        • Medical Oncology and Hematology Associates at Mercy Cancer Center
      • Des Moines, Iowa, Förenta staterna, 50314
        • Mercy Cancer Center at Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Förenta staterna, 50316
        • John Stoddard Cancer Center at Iowa Lutheran Hospital
      • Sioux City, Iowa, Förenta staterna, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, Förenta staterna, 51102
        • Mercy Medical Center - Sioux City
      • Sioux City, Iowa, Förenta staterna, 51104
        • St. Luke's Regional Medical Center
      • West Des Moines, Iowa, Förenta staterna, 50266-7700
        • Methodist West Hospital
    • Kansas
      • Chanute, Kansas, Förenta staterna, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, Förenta staterna, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, Förenta staterna, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Fort Scott, Kansas, Förenta staterna, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, Förenta staterna, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, Förenta staterna, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Lawrence, Kansas, Förenta staterna, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, Förenta staterna, 67901
        • Cancer Center of Kansas, PA - Liberal
      • Newton, Kansas, Förenta staterna, 67114
        • Cancer Center of Kansas, PA - Newton
      • Parsons, Kansas, Förenta staterna, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt, Kansas, Förenta staterna, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, Förenta staterna, 67401
        • Cancer Center of Kansas, PA - Salina
      • Wellington, Kansas, Förenta staterna, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, Förenta staterna, 67214
        • Wesley Medical Center
      • Wichita, Kansas, Förenta staterna, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, Förenta staterna, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, Förenta staterna, 67214
        • CCOP - Wichita
      • Wichita, Kansas, Förenta staterna, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Wichita, Kansas, Förenta staterna, 67208
        • Associates in Womens Health, PA - North Review
      • Winfield, Kansas, Förenta staterna, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Michigan
      • Ann Arbor, Michigan, Förenta staterna, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor, Michigan, Förenta staterna, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Battle Creek, Michigan, Förenta staterna, 49017
        • Battle Creek Health System Cancer Care Center
      • Dearborn, Michigan, Förenta staterna, 48123-2500
        • Oakwood Cancer Center at Oakwood Hospital and Medical Center
      • Escanaba, Michigan, Förenta staterna, 49431
        • Green Bay Oncology, Limited - Escanaba
      • Flint, Michigan, Förenta staterna, 48503
        • Hurley Medical Center
      • Flint, Michigan, Förenta staterna, 48503
        • Genesys Hurley Cancer Institute
      • Grand Rapids, Michigan, Förenta staterna, 49503
        • Butterworth Hospital at Spectrum Health
      • Grand Rapids, Michigan, Förenta staterna, 49503
        • CCOP - Grand Rapids
      • Grand Rapids, Michigan, Förenta staterna, 49503
        • Lacks Cancer Center at Saint Mary's Health Care
      • Grosse Pointe Woods, Michigan, Förenta staterna, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Iron Mountain, Michigan, Förenta staterna, 49801
        • Dickinson County Healthcare System
      • Jackson, Michigan, Förenta staterna, 49201
        • Foote Memorial Hospital
      • Lansing, Michigan, Förenta staterna, 48912-1811
        • Sparrow Regional Cancer Center
      • Livonia, Michigan, Förenta staterna, 48154
        • St. Mary Mercy Hospital
      • Muskegon, Michigan, Förenta staterna, 49443
        • Mercy General Health Partners
      • Pontiac, Michigan, Förenta staterna, 48341-2985
        • St. Joseph Mercy Oakland
      • Port Huron, Michigan, Förenta staterna, 48060
        • Mercy Regional Cancer Center at Mercy Hospital
      • Reed City, Michigan, Förenta staterna, 49677
        • Spectrum Health Reed City Hospital
      • Saginaw, Michigan, Förenta staterna, 48601
        • Seton Cancer Institute at Saint Mary's - Saginaw
      • Traverse City, Michigan, Förenta staterna, 49684
        • Munson Medical Center
      • Warren, Michigan, Förenta staterna, 48093
        • St. John Macomb Hospital
    • Minnesota
      • Burnsville, Minnesota, Förenta staterna, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Förenta staterna, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Duluth, Minnesota, Förenta staterna, 55805
        • CCOP - Duluth
      • Duluth, Minnesota, Förenta staterna, 55805-1983
        • Duluth Clinic Cancer Center - Duluth
      • Duluth, Minnesota, Förenta staterna, 55805
        • Miller - Dwan Medical Center
      • Edina, Minnesota, Förenta staterna, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, Förenta staterna, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Hutchinson, Minnesota, Förenta staterna, 55350
        • Hutchinson Area Health Care
      • Maplewood, Minnesota, Förenta staterna, 55109
        • HealthEast Cancer Care at St. John's Hospital
      • Maplewood, Minnesota, Förenta staterna, 55109
        • Minnesota Oncology - Maplewood
      • Minneapolis, Minnesota, Förenta staterna, 55407
        • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
      • Minneapolis, Minnesota, Förenta staterna, 55415
        • Hennepin County Medical Center - Minneapolis
      • Robbinsdale, Minnesota, Förenta staterna, 55422-2900
        • Humphrey Cancer Center at North Memorial Outpatient Center
      • Rochester, Minnesota, Förenta staterna, 55905
        • Mayo Clinic Cancer Center
      • Saint Louis Park, Minnesota, Förenta staterna, 55416
        • CCOP - Metro-Minnesota
      • Saint Louis Park, Minnesota, Förenta staterna, 55416
        • Park Nicollet Cancer Center
      • Saint Paul, Minnesota, Förenta staterna, 55102
        • United Hospital
      • Saint Paul, Minnesota, Förenta staterna, 55101
        • Regions Hospital Cancer Care Center
      • Shakopee, Minnesota, Förenta staterna, 55379
        • St. Francis Cancer Center at St. Francis Medical Center
      • Stillwater, Minnesota, Förenta staterna, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, Förenta staterna, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, Förenta staterna, 56201
        • Willmar Cancer Center at Rice Memorial Hospital
      • Woodbury, Minnesota, Förenta staterna, 55125
        • Minnesota Oncology - Woodbury
    • Missouri
      • Bolivar, Missouri, Förenta staterna, 65613
        • Central Care Cancer Center at Carrie J. Babb Cancer Center
      • Springfield, Missouri, Förenta staterna, 65802
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, Förenta staterna, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, Förenta staterna, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • Montana
      • Billings, Montana, Förenta staterna, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, Förenta staterna, 59107-7000
        • Billings Clinic - Downtown
      • Billings, Montana, Förenta staterna, 59102
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Bozeman, Montana, Förenta staterna, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, Förenta staterna, 59701
        • St. James Healthcare Cancer Care
      • Great Falls, Montana, Förenta staterna, 59405
        • Great Falls Clinic - Main Facility
      • Great Falls, Montana, Förenta staterna, 59405
        • Sletten Cancer Institute at Benefis Healthcare
      • Havre, Montana, Förenta staterna, 59501
        • Northern Montana Hospital
      • Helena, Montana, Förenta staterna, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, Förenta staterna, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, Förenta staterna, 59901
        • Glacier Oncology, PLLC
      • Kalispell, Montana, Förenta staterna, 59901
        • Kalispell Medical Oncology at KRMC
      • Missoula, Montana, Förenta staterna, 59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
      • Missoula, Montana, Förenta staterna, 59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • New Mexico
      • Albuquerque, New Mexico, Förenta staterna, 87131-5636
        • University of New Mexico Cancer Center
    • North Carolina
      • Rutherfordton, North Carolina, Förenta staterna, 28139
        • Rutherford Hospital
    • North Dakota
      • Fargo, North Dakota, Förenta staterna, 58103
        • Dakota Cancer Institute at Dakota Clinic - South University
      • Grand Forks, North Dakota, Förenta staterna, 58201
        • Altru Cancer Center at Altru Hospital
    • Ohio
      • Chillicothe, Ohio, Förenta staterna, 45601
        • Adena Regional Medical Center
      • Columbus, Ohio, Förenta staterna, 43214-3998
        • Riverside Methodist Hospital Cancer Care
      • Columbus, Ohio, Förenta staterna, 43222
        • Mount Carmel Health - West Hospital
      • Columbus, Ohio, Förenta staterna, 43215
        • CCOP - Columbus
      • Columbus, Ohio, Förenta staterna, 43215
        • Grant Medical Center Cancer Care
      • Columbus, Ohio, Förenta staterna, 43228
        • Doctors Hospital at Ohio Health
      • Dayton, Ohio, Förenta staterna, 45405
        • Grandview Hospital
      • Dayton, Ohio, Förenta staterna, 45406
        • Good Samaritan Hospital
      • Dayton, Ohio, Förenta staterna, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton, Ohio, Förenta staterna, 45415
        • Samaritan North Cancer Care Center
      • Dayton, Ohio, Förenta staterna, 45420
        • CCOP - Dayton
      • Delaware, Ohio, Förenta staterna, 43015
        • Grady Memorial Hospital
      • Findlay, Ohio, Förenta staterna, 45840
        • Blanchard Valley Medical Associates
      • Franklin, Ohio, Förenta staterna, 45005-1066
        • Middletown Regional Hospital
      • Greenville, Ohio, Förenta staterna, 45331
        • Wayne Hospital
      • Kettering, Ohio, Förenta staterna, 45429
        • Charles F. Kettering Memorial Hospital
      • Lancaster, Ohio, Förenta staterna, 43130
        • Fairfield Medical Center
      • Marietta, Ohio, Förenta staterna, 45750
        • Strecker Cancer Center at Marietta Memorial Hospital
      • Mount Vernon, Ohio, Förenta staterna, 43050
        • Knox Community Hospital
      • Newark, Ohio, Förenta staterna, 43055
        • Licking Memorial Cancer Care Program at Licking Memorial Hospital
      • Springfield, Ohio, Förenta staterna, 45505
        • Community Hospital of Springfield and Clark County
      • Troy, Ohio, Förenta staterna, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Westerville, Ohio, Förenta staterna, 43081
        • Mount Carmel St. Ann's Cancer Center
      • Xenia, Ohio, Förenta staterna, 45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
      • Zanesville, Ohio, Förenta staterna, 43701
        • Genesis - Good Samaritan Hospital
    • Pennsylvania
      • Danville, Pennsylvania, Förenta staterna, 17822-0001
        • Geisinger Cancer Institute at Geisinger Health
      • Hazleton, Pennsylvania, Förenta staterna, 18201
        • Geisinger Hazleton Cancer Center
      • State College, Pennsylvania, Förenta staterna, 16801
        • Geisinger Medical Group - Scenery Park
      • Wilkes-Barre, Pennsylvania, Förenta staterna, 18711
        • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
    • South Carolina
      • Anderson, South Carolina, Förenta staterna, 29621
        • AnMed Cancer Center
      • Greenville, South Carolina, Förenta staterna, 29601
        • Bon Secours St. Francis Health System
      • Spartanburg, South Carolina, Förenta staterna, 29303
        • CCOP - Upstate Carolina
      • Spartanburg, South Carolina, Förenta staterna, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, Förenta staterna, 57105
        • Avera Cancer Institute
    • Wisconsin
      • Eau Claire, Wisconsin, Förenta staterna, 54703-1510
        • Midelfort Clinic - Luther
      • Eau Claire, Wisconsin, Förenta staterna, 54703
        • Luther Midlelfort Hospital
      • Green Bay, Wisconsin, Förenta staterna, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, Förenta staterna, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, Förenta staterna, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, Förenta staterna, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • Manitowoc, Wisconsin, Förenta staterna, 54221-1450
        • Holy Family Memorial Medical Center Cancer Care Center
      • Marinette, Wisconsin, Förenta staterna, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Oconto Falls, Wisconsin, Förenta staterna, 54154
        • Green Bay Oncology, Limited - Oconto Falls
      • Sheboygan, Wisconsin, Förenta staterna, 53081
        • St. Nicholas Hospital
      • Sturgeon Bay, Wisconsin, Förenta staterna, 54235
        • Green Bay Oncology, Limited - Sturgeon Bay
      • Sturgeon Bay, Wisconsin, Förenta staterna, 54235-1495
        • Door County Cancer Center at Door County Memorial Hospital
    • Wyoming
      • Sheridan, Wyoming, Förenta staterna, 82801
        • Welch Cancer Center at Sheridan Memorial Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: oxaliplatin
Givet IV
Läkemedel: fluorouracil
Givet IV
Läkemedel: capecitabin
Givet PO
Procedur: terapeutisk konventionell kirurgi
Genomgå kirurgi
Strålning: strålbehandling
Genomgå strålbehandling
Läkemedel: docetaxel
Givet IV
Aktiv komparator: 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.
Läkemedel: oxaliplatin
Givet IV
Läkemedel: fluorouracil
Givet IV
Procedur: terapeutisk konventionell kirurgi
Genomgå kirurgi
Strålning: strålbehandling
Genomgå strålbehandling

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants With Pathologic Complete Response (PCR)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Survival
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbetspartners

National Cancer Institute (NCI)

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2010

Primärt slutförande (Faktisk)

1 december 2013

Avslutad studie (Faktisk)

1 mars 2018

Studieregistreringsdatum

Först inskickad

10 juli 2009

Först inskickad som uppfyllde QC-kriterierna

10 juli 2009

Första postat (Uppskatta)

13 juli 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 mars 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 mars 2018

Senast verifierad

1 mars 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NCCTG-N0849
  • NCI-2011-01930 (Registeridentifierare: CTRP (Clinical Trials Reporting System))
  • CDR0000646724 (Registeridentifierare: PDQ (Physician Data Query))

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