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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 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

73

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: oksaliplatin
Gitt IV
Legemiddel: fluorouracil
Gitt IV
Legemiddel: capecitabin
Gitt PO
Fremgangsmåte: terapeutisk konvensjonell kirurgi
Å bli operert
Stråling: strålebehandling
Gjennomgå strålebehandling
Legemiddel: docetaksel
Gitt 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.
Legemiddel: oksaliplatin
Gitt IV
Legemiddel: fluorouracil
Gitt IV
Fremgangsmåte: terapeutisk konvensjonell kirurgi
Å bli operert
Stråling: strålebehandling
Gjennomgå strålebehandling

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With Pathologic Complete Response (PCR)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Survival
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbeidspartnere

National Cancer Institute (NCI)

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2010

Primær fullføring (Faktiske)

1. desember 2013

Studiet fullført (Faktiske)

1. mars 2018

Datoer for studieregistrering

Først innsendt

10. juli 2009

Først innsendt som oppfylte QC-kriteriene

10. juli 2009

Først lagt ut (Anslag)

13. juli 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. mars 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. mars 2018

Sist bekreftet

1. mars 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere