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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

98

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

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

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Chemo Plus RT, Surgery, Chemo
neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
Legemiddel: 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 navn:
  • 5-FU
Legemiddel: 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 navn:
  • eloxatin
Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
Tidsramme
Antall pasienter med grad 3 til 5 uønskede hendelser som er relatert til studiemedikament
Tidsramme: Inntil 3 år
Bare uønskede hendelser som er mulig, sannsynligvis eller definitivt relatert til studiemedikamentet er rapportert.
Inntil 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

Samarbeidspartnere og etterforskere

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

Sponsor

Southwest Oncology Group

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

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

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. september 2004

Primær fullføring (Faktiske)

1. august 2009

Studiet fullført (Faktiske)

1. august 2011

Datoer for studieregistrering

Først innsendt

8. juli 2004

Først innsendt som oppfylte QC-kriteriene

9. juli 2004

Først lagt ut (Anslag)

12. juli 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

11. oktober 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. september 2013

Sist bekreftet

1. september 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

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. .

Kliniske studier på Kreft i spiserøret

Kliniske studier på fluorouracil

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

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