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S0356 Oxaliplatin, 5-FU, Radiation Therapy (RT), Surgery for Pts With Stage II or III Cancer of Esophagus or Gastroesophageal (GE) Junction

4. september 2013 opdateret af: Southwest Oncology Group

Oxaliplatin (NSC-266046) Plus Protracted Infusion 5-Fluorouracil And Radiation For Potentially Curable Esophageal Cancer: A Phase II Trial With Molecular Correlates

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Oxaliplatin and fluorouracil may make tumor cells more sensitive to radiation therapy and may kill more tumor cells. Giving chemotherapy and radiation therapy before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well giving oxaliplatin together with fluorouracil and radiation therapy works in treating patients who are undergoing surgery for stage II or stage III cancer of the esophagus or gastroesophageal junction.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Determine the pathologic complete response probability in patients with stage II or III adenocarcinoma of the esophagus or gastroesophageal junction treated with neoadjuvant oxaliplatin, fluorouracil, and radiotherapy followed by definitive surgical resection.

Secondary

  • Determine the frequency and severity of toxic effects associated with this neoadjuvant regimen in these patients.
  • Determine the overall survival and progression-free survival of patients treated with this regimen.

Exploratory Analyses (subject to funding availability)

  • Correlate, preliminarily, initial messenger ribonucleic acid (mRNA) levels of the genes for thymidylate synthase (TS), γ-glutamyl transpeptidase (γGT), γ-glutamyl cysteine (γ-GCS), DNA excision repair cross-complementing (ERCC-1), and xeroderma pigmentosum (XPA) with response and survival of patients treated with this regimen.
  • Correlate, preliminarily, the mRNA levels of TS, γGT, γ-GCS, ERCC-1, and XPA before and after treatment with this regimen with survival of these patients.
  • Correlate, preliminarily, specific genetic polymorphisms of TS and ERCC-1 with tumor response and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Neoadjuvant chemoradiotherapy: Patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil (5-FU) IV continuously on days 8-43. Beginning on day 8, patients also undergo radiotherapy once daily, 5 days a week, for 5 weeks.
  • Surgery: Patients with stable disease or better undergo surgical resection 4-10 weeks after completion of chemoradiotherapy.
  • Adjuvant chemotherapy: Beginning 4-10 weeks after surgery, patients receive chemotherapy comprising oxaliplatin IV over 2 hours on days 1, 15, and 29 and 5-FU IV continuously on days 1-36.

Treatment continues in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 45-85 patients will be accrued for this study within 17-21 months.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

98

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Mobile, Alabama, Forenede Stater, 36652-2144
        • Mobile Infirmary Medical Center
    • Alaska
      • Anchorage, Alaska, Forenede Stater, 99508
        • Providence Cancer Center
    • Arkansas
      • Bentonville, Arkansas, Forenede Stater, 72712
        • Highlands Oncology Group - Springdale
    • California
      • Castro Valley, California, Forenede Stater, 94546
        • East Bay Radiation Oncology Center
      • Castro Valley, California, Forenede Stater, 94546
        • Eden Medical Center
      • Castro Valley, California, Forenede Stater, 94546
        • Valley Medical Oncology Consultants - Castro Valley
      • Fremont, California, Forenede Stater, 94538
        • Valley Medical Oncology
      • Los Angeles, California, Forenede Stater, 90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Oakland, California, Forenede Stater, 94609
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland, California, Forenede Stater, 94602
        • Highland General Hospital
      • Oakland, California, Forenede Stater, 94609
        • Larry G Strieff MD Medical Corporation
      • Oakland, California, Forenede Stater, 94609
        • CCOP - Bay Area Tumor Institute
      • Oakland, California, Forenede Stater, 94609
        • Bay Area Breast Surgeons, Incorporated
      • Oakland, California, Forenede Stater, 94609
        • Tom K Lee, Incorporated
      • Palm Springs, California, Forenede Stater, 92262
        • Desert Regional Medical Center Comprehensive Cancer Center
      • Pleasanton, California, Forenede Stater, 94588
        • Valley Care Medical Center
      • Pleasanton, California, Forenede Stater, 94588
        • Valley Medical Oncology Consultants - Pleasanton
      • Sacramento, California, Forenede Stater, 95817
        • University of California Davis Cancer Center
      • San Pablo, California, Forenede Stater, 94806
        • Doctors Medical Center - San Pablo Campus
    • Colorado
      • Fort Collins, Colorado, Forenede Stater, 80524
        • Poudre Valley Hospital
    • Georgia
      • Gainesville, Georgia, Forenede Stater, 30501
        • Northeast Georgia Medical Center
      • Savannah, Georgia, Forenede Stater, 31403-3089
        • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Illinois
      • Alton, Illinois, Forenede Stater, 62002
        • Saint Anthony's Hospital at Saint Anthony's Health Center
      • Decatur, Illinois, Forenede Stater, 62526
        • Decatur Memorial Hospital Cancer Care Institute
      • Maywood, Illinois, Forenede Stater, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
      • Mt. Vernon, Illinois, Forenede Stater, 62864
        • Good Samaritan Regional Health Center
      • Springfield, Illinois, Forenede Stater, 62781-0001
        • Regional Cancer Center at Memorial Medical Center
    • Indiana
      • Beech Grove, Indiana, Forenede Stater, 46107
        • St. Francis Hospital and Health Centers - Beech Grove Campus
      • Richmond, Indiana, Forenede Stater, 47374
        • Reid Hospital & Health Care Services
    • Kansas
      • Chanute, Kansas, Forenede Stater, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, Forenede Stater, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, Forenede Stater, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Kansas City, Kansas, Forenede Stater, 66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
      • Kingman, Kansas, Forenede Stater, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Liberal, Kansas, Forenede Stater, 67901
        • Southwest Medical Center
      • Newton, Kansas, Forenede Stater, 67114
        • Cancer Center of Kansas, PA - Newton
      • Olathe, Kansas, Forenede Stater, 66061
        • Olathe Cancer Center
      • Parsons, Kansas, Forenede Stater, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt, Kansas, Forenede Stater, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, Forenede Stater, 67042
        • Cancer Center of Kansas, PA - Salina
      • Topeka, Kansas, Forenede Stater, 66606
        • Cotton-O'Neil Cancer Center
      • Topeka, Kansas, Forenede Stater, 66606
        • St. Francis Comprehensive Cancer Center
      • Wellington, Kansas, Forenede Stater, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, Forenede Stater, 67214
        • Wesley Medical Center
      • Wichita, Kansas, Forenede Stater, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, Forenede Stater, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, Forenede Stater, 67214
        • CCOP - Wichita
      • Wichita, Kansas, Forenede Stater, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Wichita, Kansas, Forenede Stater, 67208
        • Associates in Womens Health, PA - North Review
      • Winfield, Kansas, Forenede Stater, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536-0093
        • Lucille P. Markey Cancer Center at University of Kentucky
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston University Cancer Research Center
    • Michigan
      • Battle Creek, Michigan, Forenede Stater, 49017
        • Battle Creek Health System Cancer Care Center
      • Big Rapids, Michigan, Forenede Stater, 49307
        • Mecosta County Medical Center
      • Detroit, Michigan, Forenede Stater, 48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
      • Detroit, Michigan, Forenede Stater, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Butterworth Hospital at Spectrum Health
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • CCOP - Grand Rapids
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Lacks Cancer Center at Saint Mary's Health Care
      • Grand Rapids, Michigan, Forenede Stater, 49506
        • Metro Health Hospital
      • Holland, Michigan, Forenede Stater, 49423
        • Holland Community Hospital
      • Muskegon, Michigan, Forenede Stater, 49442
        • Hackley Hospital
      • Traverse City, Michigan, Forenede Stater, 49684
        • Munson Medical Center
    • Missouri
      • Cape Girardeau, Missouri, Forenede Stater, 63703
        • Saint Francis Medical Center
      • Gape Girardeau, Missouri, Forenede Stater, 63701
        • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
      • Joplin, Missouri, Forenede Stater, 64804
        • St. John's Regional Medical Center
      • Kansas City, Missouri, Forenede Stater, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, Forenede Stater, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Saint Louis, Missouri, Forenede Stater, 63141
        • David C. Pratt Cancer Center at St. John's Mercy
      • Springfield, Missouri, Forenede Stater, 65802
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, Forenede Stater, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, Forenede Stater, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • Montana
      • Billings, Montana, Forenede Stater, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, Forenede Stater, 59101
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Billings, Montana, Forenede Stater, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, Forenede Stater, 59101
        • St. Vincent Healthcare Cancer Care Services
      • Billings, Montana, Forenede Stater, 59107-7000
        • Billings Clinic - Downtown
      • Bozeman, Montana, Forenede Stater, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, Forenede Stater, 59701
        • St. James Healthcare Cancer Care
      • Great Falls, Montana, Forenede Stater, 59405
        • Great Falls Clinic - Main Facility
      • Great Falls, Montana, Forenede Stater, 59405-5309
        • Big Sky Oncology
      • Great Falls, Montana, Forenede Stater, 59405
        • Sletten Cancer Institute at Benefis Healthcare
      • Great Falls, Montana, Forenede Stater, 59405
        • Frontier Cancer Center
      • Helena, Montana, Forenede Stater, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, Forenede Stater, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, Forenede Stater, 59901
        • Glacier Oncology, PLLC
      • Kalispell, Montana, Forenede Stater, 59901
        • Kalispell Medical Oncology at KRMC
      • Missoula, Montana, Forenede Stater, 59801
        • Community Medical Center
      • Missoula, Montana, Forenede Stater, 59804
        • Guardian Oncology and Center for Wellness
      • Missoula, Montana, Forenede Stater, 59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
      • Missoula, Montana, Forenede Stater, 59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • Nebraska
      • Kearney, Nebraska, Forenede Stater, 68848-1990
        • Good Samaritan Cancer Center at Good Samaritan Hospital
    • New York
      • Middletown, New York, Forenede Stater, 10940-4199
        • Tucker Center for Cancer Care at Orange Regional Medical Center
    • North Carolina
      • Asheboro, North Carolina, Forenede Stater, 27203-5400
        • Randolph Hospital
      • Asheville, North Carolina, Forenede Stater, 28801
        • Mission Hospitals - Memorial Campus
      • Greensboro, North Carolina, Forenede Stater, 27403-1198
        • Moses Cone Regional Cancer Center at Wesley Long Community Hospital
      • Reidsville, North Carolina, Forenede Stater, 27320
        • Annie Penn Cancer Center
      • Rutherfordton, North Carolina, Forenede Stater, 28139
        • Rutherford Hospital
    • Ohio
      • Akron, Ohio, Forenede Stater, 44307
        • McDowell Cancer Center at Akron General Medical Center
      • Cincinnati, Ohio, Forenede Stater, 45267
        • Charles M. Barrett Cancer Center at University Hospital
      • Dayton, Ohio, Forenede Stater, 45428
        • Veterans Affairs Medical Center - Dayton
      • Dayton, Ohio, Forenede Stater, 45405
        • Grandview Hospital
      • Dayton, Ohio, Forenede Stater, 45406
        • Good Samaritan Hospital
      • Dayton, Ohio, Forenede Stater, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton, Ohio, Forenede Stater, 45415
        • Samaritan North Cancer Care Center
      • Dayton, Ohio, Forenede Stater, 45429
        • CCOP - Dayton
      • Findlay, Ohio, Forenede Stater, 45840
        • Blanchard Valley Medical Associates
      • Franklin, Ohio, Forenede Stater, 45005-1066
        • Middletown Regional Hospital
      • Kettering, Ohio, Forenede Stater, 45429
        • Charles F. Kettering Memorial Hospital
      • Troy, Ohio, Forenede Stater, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Wilmington, Ohio, Forenede Stater, 45177
        • Clinton Memorial Hospital
      • Xenia, Ohio, Forenede Stater, 45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
    • South Carolina
      • Anderson, South Carolina, Forenede Stater, 29621
        • AnMed Cancer Center
      • Greenville, South Carolina, Forenede Stater, 29615
        • CCOP - Greenville
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • CCOP - Upstate Carolina
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • Tennessee
      • Kingsport, Tennessee, Forenede Stater, 37662
        • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
    • Texas
      • Temple, Texas, Forenede Stater, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • American Fork, Utah, Forenede Stater, 84003
        • American Fork Hospital
      • Cedar City, Utah, Forenede Stater, 84720
        • Sandra L. Maxwell Cancer Center
      • Logan, Utah, Forenede Stater, 84321
        • Logan Regional Hospital
      • Murray, Utah, Forenede Stater, 84157
        • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
      • Ogden, Utah, Forenede Stater, 84403
        • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
      • Provo, Utah, Forenede Stater, 84604
        • Utah Valley Regional Medical Center - Provo
      • Saint George, Utah, Forenede Stater, 84770
        • Dixie Regional Medical Center - East Campus
      • Salt Lake City, Utah, Forenede Stater, 84103
        • LDS Hospital
      • Salt Lake City, Utah, Forenede Stater, 84106
        • Utah Cancer Specialists at UCS Cancer Center
    • Virginia
      • Norton, Virginia, Forenede Stater, 24273
        • Southwest Virginia Regional Cancer Center at Wellmonth Health
    • Washington
      • Bellingham, Washington, Forenede Stater, 98225
        • St. Joseph Cancer Center
      • Bremerton, Washington, Forenede Stater, 98310
        • Olympic Hematology and Oncology
      • Kennewick, Washington, Forenede Stater, 99336
        • Columbia Basin Hematology
      • Seattle, Washington, Forenede Stater, 98104
        • Harborview Medical Center
      • Seattle, Washington, Forenede Stater, 98108
        • Veterans Affairs Medical Center - Seattle
      • Seattle, Washington, Forenede Stater, 98104
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, Forenede Stater, 98104
        • Minor and James Medical, PLLC
      • Seattle, Washington, Forenede Stater, 98112
        • Group Health Central Hospital
      • Seattle, Washington, Forenede Stater, 98122-4307
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Seattle, Washington, Forenede Stater, 98122
        • Polyclinic First Hill
      • Seattle, Washington, Forenede Stater, 98195-6043
        • University Cancer Center at University of Washington Medical Center
      • Spokane, Washington, Forenede Stater, 99202
        • Cancer Care Northwest - Spokane South
      • Spokane, Washington, Forenede Stater, 99204-2967
        • Rockwood Clinic Cancer Treatment Center
      • Wenatchee, Washington, Forenede Stater, 98801-2028
        • Wenatchee Valley Medical Center
    • Wyoming
      • Sheridan, Wyoming, Forenede Stater, 82801
        • Welch Cancer Center at Sheridan Memorial Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary adenocarcinoma of the thoracic esophagus or gastroesophageal junction

    • No recurrent disease
    • Primary esophageal tumor at least 20 cm below the incisors (if < 26 cm below the incisors, a bronchoscopy must be performed and cytology must be negative)
    • Esophageal disease confined to esophagus and peri-esophageal soft tissue
    • Gastroesophageal junction disease extending ≤ 2 cm into the gastric cardia

  • Clinical stage II or III disease by CT scan or MRI

    • If no esophageal mass is detected by these methods, esophageal endoscopic ultrasound is required to determine stage
    • Positron-emission tomography scan is required to confirm stage
  • Measurable or non-measurable disease by x-ray, scanning, or physical examination

  • No celiac axis nodes ≥ 1.5 cm

    • Measurable regional lymph nodes ≥ 1.5 cm at stations 2-10=N1 OR subdiaphragmatic lymph nodes at stations 15-19 ≤ 1.5 cm by CT scan or MRI allowed
    • Palpable supraclavicular lymph nodes must be free of metastatic esophageal cancer by biopsy

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • White blood cell (WBC) count ≥ 3,000/mm^3
  • Hemoglobin ≥ 10.0 g/dL (transfusion allowed)

Hepatic

  • Albumin ≥ 3 g/dL
  • Bilirubin normal

Renal

  • Creatinine ≤ 1.5 times upper limit of normal

Cardiovascular

  • No myocardial infarction or cerebrovascular event within the past 6 months

Pulmonary

  • No active pneumonia or inflammatory lung infiltrate

Other

  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No peripheral neuropathy ≥ grade 2
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for esophageal cancer

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy for esophageal cancer
  • No concurrent intensity-modulated radiotherapy

Surgery

  • No prior surgical resection or attempted surgical resection of esophageal cancer

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Chemo Plus RT, Surgery, Chemo
neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
Medicin: fluorouracil
Before surgery: 180 mg/m2/day by 24-hour infusion days 8 through 43. After surgery:180 mg/m2/day by 24-hour infusion days 1 through 36.
Andre navne:
  • 5-FU
Medicin: oxaliplatin
Before surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29. After surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29.
Andre navne:
  • eloxatin
Procedure: conventional surgery
The surgical technique will depend upon the location and extent of tumor and individual surgeon preference.
Stråling: radiation therapy
Starting Day 8, patients will be treated 5 days/week at 180 centigray (cGy)/day times 25 fractions to a total dose of 4,500 cGy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pathological Complete Response
Tidsramme: 10-16 weeks after beginning study treatment
Complete pathologic response assessed after chemoradiotherapy and surgery, defined as no evidence of residual disease on path review. Patients who did not receive surgery are assumed to have not responded.
10-16 weeks after beginning study treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Antal patienter med grad 3 til 5 bivirkninger, der er relateret til undersøgelsesmedicin
Tidsramme: Op til 3 år
Kun uønskede hændelser, der muligvis, sandsynligvis eller helt sikkert er relateret til undersøgelseslægemidlet, er rapporteret.
Op til 3 år
Overall Survival
Tidsramme: 0-5 years
Measured from time of registration to death, or last contact date
0-5 years
Progression-free Survival
Tidsramme: 0-3 years
measured from date of registration to time of first documentation of progression by Response Evaluation Criteria in Solid Tumors (RECIST), death, or last contact date.
0-3 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Southwest Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Studiestol: Lawrence P. Leichman, MD, Desert Regional Medical Center Comprehensive Cancer Center
  • Studiestol: Charles R. Thomas, MD, OHSU Knight Cancer Institute

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2004

Primær færdiggørelse (Faktiske)

1. august 2009

Studieafslutning (Faktiske)

1. august 2011

Datoer for studieregistrering

Først indsendt

8. juli 2004

Først indsendt, der opfyldte QC-kriterier

9. juli 2004

Først opslået (Skøn)

12. juli 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. oktober 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. september 2013

Sidst verificeret

1. september 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000371963
  • U10CA032102 (U.S. NIH-bevilling/kontrakt)
  • S0356 (Anden identifikator: SWOG)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Spiserørskræft

Kliniske forsøg med fluorouracil

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Singapore

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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