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S0414 Cetuximab, Combo Chemo, and RT in Locally Advanced Esophageal Cancer

16 november 2015 uppdaterad av: Southwest Oncology Group

Cetuximab Plus Cisplatin, Irinotecan and Thoracic Radiotherapy (TRT) for Locally Advanced (Non-Metastatic), Clinically Unresectable Esophageal Cancer: A Phase II Trial With Molecular Correlates

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of esophageal cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab together with combination chemotherapy and radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy and radiation therapy works in treating patients with locally advanced esophageal cancer that cannot be removed by surgery.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

OBJECTIVES:

Primary

  • Determine the 2-year overall survival of patients with previously untreated, clinically unresectable, locally advanced squamous cell carcinoma or adenocarcinoma of the esophagus treated with cetuximab, cisplatin, irinotecan, and thoracic radiotherapy.

Secondary

  • Determine the toxicity profile of this regimen in these patients.
  • Determine the probability of objective response (confirmed and unconfirmed, complete and partial) in patients with measurable disease treated with this regimen.
  • Determine the time to progression in patients with measurable disease treated with this regimen.
  • Correlate, preliminarily, gene expression (RNA) levels and germline polymorphisms of genes involved in DNA repair (e.g., ECRCC-1 and XRCC-1), drug metabolism (e.g., UGT1A1), and the epidermal growth factor receptor (EGFR) pathway (e.g., EGFR, interleukin-8, and vascular endothelial growth factor) with response, time to progression, overall survival, and toxicity in patients treated with this regimen. (This will not be completed as this study was closed due to poor accrual.)

OUTLINE: This is a multicenter study.

Patients receive cetuximab intravenous (IV) over 1-2 hours on days 1, 8, and 15. Patients also receive cisplatin IV and irinotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of course 3, patients undergo thoracic radiotherapy once daily 5 days a week for 5-6 weeks (total of 28 treatments).

After completion of study treatment, patients are followed at 4 weeks and then every 3-6 months for up to 5 years after study entry.

PROJECTED ACCRUAL: A total of 75-100 patients (75 with adenocarcinoma and 25 with squamous cell carcinoma) will be accrued for this study.

Studietyp

Interventionell

Inskrivning (Faktisk)

22

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
    • Alabama
      • Mobile, Alabama, Förenta staterna, 36652-2144
        • Mobile Infirmary Medical Center
    • Arkansas
      • Little Rock, Arkansas, Förenta staterna, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Berkeley, California, Förenta staterna, 94704
        • Alta Bates Comprehensive Cancer Center
      • Burbank, California, Förenta staterna, 91505
        • Providence Saint Joseph Medical Center - Burbank
      • Burlingame, California, Förenta staterna, 94010
        • Peninsula Medical Center
      • Castro Valley, California, Förenta staterna, 94546
        • Eden Medical Center
      • Greenbrae, California, Förenta staterna, 94904
        • Marin Cancer Institute at Marin General Hospital
      • Greenbrae, California, Förenta staterna, 94904
        • Sutter Health - Western Division Cancer Research Group
      • Hayward, California, Förenta staterna, 94545
        • Saint Rose Hospital
      • Los Angeles, California, Förenta staterna, 90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Oakland, California, Förenta staterna, 94609
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland, California, Förenta staterna, 94602
        • Highland General Hospital
      • Oakland, California, Förenta staterna, 94609
        • CCOP - Bay Area Tumor Institute
      • Palm Springs, California, Förenta staterna, 92262
        • Desert Regional Medical Center Comprehensive Cancer Center
      • Pleasanton, California, Förenta staterna, 94588
        • Valley Care Medical Center
      • Sacramento, California, Förenta staterna, 95817
        • University of California Davis Cancer Center
      • San Francisco, California, Förenta staterna, 94118
        • California Pacific Medical Center - California Campus
      • San Pablo, California, Förenta staterna, 94806
        • Doctors Medical Center - San Pablo Campus
      • Sana Rosa, California, Förenta staterna, 95405
        • CCOP - Santa Rosa Memorial Hospital
      • Vallejo, California, Förenta staterna, 94589
        • Sutter Solano Medical Center
    • Colorado
      • Fort Collins, Colorado, Förenta staterna, 80524
        • Poudre Valley Hospital
    • Florida
      • Lakeland, Florida, Förenta staterna, 33804-5000
        • Watson Clinic, LLC
    • Georgia
      • Augusta, Georgia, Förenta staterna, 30901
        • Augusta Oncology Associates - Walton Way
      • Savannah, Georgia, Förenta staterna, 31403-3089
        • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
      • Savannah, Georgia, Förenta staterna, 31405
        • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
    • Idaho
      • Boise, Idaho, Förenta staterna, 83712
        • St. Luke's Mountain States Tumor Institute - Boise
    • Illinois
      • Springfield, Illinois, Förenta staterna, 62781-0001
        • Regional Cancer Center at Memorial Medical Center
    • 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, Incorporated
    • 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
      • Kansas City, Kansas, Förenta staterna, 66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
      • Kingman, Kansas, Förenta staterna, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Liberal, Kansas, Förenta staterna, 67901
        • Southwest Medical Center
      • 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, 67042
        • Cancer Center of Kansas, PA - Salina
      • Salina, Kansas, Förenta staterna, 67401
        • Tammy Walker Cancer Center at Salina Regional Health Center
      • Wellington, Kansas, Förenta staterna, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, Förenta staterna, 67214
        • Wesley Medical Center
      • Wichita, Kansas, Förenta staterna, 67203
        • Associates in Womens Health, PA - North Review
      • 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
      • Winfield, Kansas, Förenta staterna, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Kentucky
      • Lexington, Kentucky, Förenta staterna, 40536-0293
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
    • Michigan
      • Ann Arbor, Michigan, Förenta staterna, 48109-0942
        • University of Michigan Comprehensive Cancer Center
      • Battle Creek, Michigan, Förenta staterna, 49017
        • Battle Creek Health System Cancer Care Center
      • Big Rapids, Michigan, Förenta staterna, 49307
        • Mecosta County Medical Center
      • Detroit, Michigan, Förenta staterna, 48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
      • Grand Rapids, Michigan, Förenta staterna, 49503
        • CCOP - Grand Rapids
      • Grand Rapids, Michigan, Förenta staterna, 49503
        • Lacks Cancer Center at Saint Mary's Health Care
      • Grand Rapids, Michigan, Förenta staterna, 49506
        • Metro Health Hospital
      • Grand Rapids, Michigan, Förenta staterna, 49503
        • Spectrum Health Hospital - Butterworth Campus
      • Holland, Michigan, Förenta staterna, 49423
        • Holland Community Hospital
      • Muskegon, Michigan, Förenta staterna, 49442
        • Hackley Hospital
      • Traverse City, Michigan, Förenta staterna, 49684
        • Munson Medical Center
    • Missouri
      • Kansas City, Missouri, Förenta staterna, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, Förenta staterna, 63110
        • Saint Louis University 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, 59101
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Billings, Montana, Förenta staterna, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, Förenta staterna, 59101
        • St. Vincent Healthcare Cancer Care Services
      • Billings, Montana, Förenta staterna, 59107-7000
        • Billings Clinic - Downtown
      • 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
      • 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, 59801
        • Community Medical Center
      • Missoula, Montana, Förenta staterna, 59804
        • Guardian Oncology and Center for Wellness
      • 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
    • Nebraska
      • Kearney, Nebraska, Förenta staterna, 68848-1990
        • Good Samaritan Cancer Center at Good Samaritan Hospital
    • New York
      • Rochester, New York, Förenta staterna, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Rochester, New York, Förenta staterna, 14623
        • Interlakes Oncology/Hematology PC
    • North Carolina
      • Goldsboro, North Carolina, Förenta staterna, 27534
        • Wayne Memorial Hospital, Incorporated
    • Ohio
      • Akron, Ohio, Förenta staterna, 44307
        • McDowell Cancer Center at Akron General Medical Center
      • Dayton, Ohio, Förenta staterna, 45428
        • Veterans Affairs Medical Center - Dayton
      • 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, 45429
        • CCOP - Dayton
      • Findlay, Ohio, Förenta staterna, 45840
        • Blanchard Valley Medical Associates
      • Kettering, Ohio, Förenta staterna, 45429
        • Charles F. Kettering Memorial Hospital
      • Middletown, Ohio, Förenta staterna, 45044
        • Middletown Regional Hospital
      • Troy, Ohio, Förenta staterna, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Xenia, Ohio, Förenta staterna, 45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
    • Oregon
      • Gresham, Oregon, Förenta staterna, 97030
        • Legacy Mount Hood Medical Center
      • Milwaukie, Oregon, Förenta staterna, 97222
        • Providence Milwaukie Hospital
      • Portland, Oregon, Förenta staterna, 97227
        • Northwest Cancer Specialists at Rose Quarter Cancer Center
      • Portland, Oregon, Förenta staterna, 97213-2967
        • Providence Cancer Center at Providence Portland Medical Center
      • Portland, Oregon, Förenta staterna, 97225
        • CCOP - Columbia River Oncology Program
      • Portland, Oregon, Förenta staterna, 97225
        • Providence St. Vincent Medical Center
      • Portland, Oregon, Förenta staterna, 97210
        • Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
      • Portland, Oregon, Förenta staterna, 97227
        • Legacy Emanuel Hospital and Health Center & Children's Hospital
      • Portland, Oregon, Förenta staterna, 97239-3098
        • Oregon Health & Science University Cancer Institute
      • Salem, Oregon, Förenta staterna, 97309-5014
        • Salem Hospital Regional Cancer Care Services
      • Tualatin, Oregon, Förenta staterna, 97062
        • Legacy Meridian Park Hospital
    • South Carolina
      • Charleston, South Carolina, Förenta staterna, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Charleston, South Carolina, Förenta staterna, 29401
        • Roper St. Francis Cancer Center at Roper Hospital
      • Greenville, South Carolina, Förenta staterna, 29615
        • CCOP - Greenville
    • Tennessee
      • Kingsport, Tennessee, Förenta staterna, 37662
        • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
      • Knoxville, Tennessee, Förenta staterna, 37920-6999
        • U.T. Cancer Institute at University of Tennessee Medical Center
    • Virginia
      • Danville, Virginia, Förenta staterna, 24541
        • Danville Regional Medical Center
      • Norton, Virginia, Förenta staterna, 24273
        • Southwest Virginia Regional Cancer Center
    • Washington
      • Bellingham, Washington, Förenta staterna, 98225
        • St. Joseph Cancer Center
      • Bremerton, Washington, Förenta staterna, 98310
        • Olympic Hematology and Oncology
      • Kennewick, Washington, Förenta staterna, 99336
        • Columbia Basin Hematology
      • Mt. Vernon, Washington, Förenta staterna, 98273
        • Skagit Valley Hospital Cancer Care Center
      • Seattle, Washington, Förenta staterna, 98104
        • Harborview Medical Center
      • Seattle, Washington, Förenta staterna, 98104
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, Förenta staterna, 98104
        • Minor and James Medical, PLLC
      • Seattle, Washington, Förenta staterna, 98112
        • Group Health Central Hospital
      • Seattle, Washington, Förenta staterna, 98122-4307
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Seattle, Washington, Förenta staterna, 98122
        • Polyclinic First Hill
      • Seattle, Washington, Förenta staterna, 98195-6043
        • University Cancer Center at University of Washington Medical Center
      • Spokane, Washington, Förenta staterna, 99202
        • Cancer Care Northwest - Spokane South
      • Vancouver, Washington, Förenta staterna, 98684
        • Northwest Cancer Specialists at Vancouver Cancer Center
      • Vancouver, Washington, Förenta staterna, 98668
        • Southwest Washington Medical Center Cancer Center
      • Wenatchee, Washington, Förenta staterna, 98801-2028
        • Wenatchee Valley Medical Center
    • 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

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (≥ 20 cm from the incisors*) or the gastroesophageal junction (confined to ≤ 2 cm into the gastric cardia)

    • Disease confined to the esophagus or peri-esophageal soft tissue
    • T4, M0 disease
    • Surgically unresectable disease by esophageal endoscopic ultrasonography OR medically unresectable disease

NOTE: *Patients with primary disease < 26 cm from the incisors must undergo bronchoscopy AND have negative cytology within the past 4 weeks

  • Measurable or non-measurable disease by x-ray, CT scan and/or MRI, or physical examination within the past 4 weeks (for measurable disease) or within the past 6 weeks (for non-measurable disease)
  • Tumor specimens available
  • No recurrent disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count (ANC) ≥ 1,500/mm^3
  • White Blood Cell (WBC) count ≥ 3,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10.0 g/dL

Hepatic

  • Albumin normal
  • Bilirubin normal
  • Alkaline phosphatase normal
  • Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 times upper limit of normal

Renal

  • Creatinine clearance > 50 mL/min

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No prior severe reaction to monoclonal antibodies
  • 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

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
  • No concurrent cobalt-60

Surgery

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

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: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Treatment
Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3.
Biologisk: cetuximab
400mg/m^2 loading dose, intravenous (IV) over 120 min, day 1 of cycle 1 only. 250mg/m^2 maintenance dose, IV over 60 min, Days 8 & 15 of Cycle 1 and Days 1, 8, and 15 of subsequent cycles.
Andra namn:
  • Erbitux
Läkemedel: cisplatin
30mg/m^2, bolus intravenous (IV), on Days 1 & 8 of each cycle.
Andra namn:
  • Platinol
Läkemedel: irinotecan hydrochloride
65mg/m^2, intravenous (IV) over 30 min, on Days 1 & 8 of each cycle.
Andra namn:
  • CPT-11
Strålning: radiation therapy
The total dose to the prescription point will be 5,040 cGy given in 28 fractions. The patient will be treated with one fraction per day with all fields treated per day. 180 cGy will be delivered to the isocenter. The dose variation in the planning target volume (PTV) will be +7% and -5% of the prescription point dose.
Andra namn:
  • RT
  • TRT

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Survival at 2 Years
Tidsram: 0-2 years
Measured from time of registration to date of death due to any cause, or last contact date
0-2 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Tidsram: Patients were assessed for adverse events after every two cycles of chemotherapy.
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Patients were assessed for adverse events after every two cycles of chemotherapy.
Objective Response (Confirmed and Unconfined, Complete and Partial)
Tidsram: at week 16, then every 3 months until progression
Complete response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. Partial response (PR) applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.
at week 16, then every 3 months until progression
Progression Free Survival
Tidsram: 0 - 5 years
Measured from date of registration to date of first observation of progression or symptomatic deterioration. Patients last known to be alive and progression-free are censored at date of last contact.
0 - 5 years

Samarbetspartners och utredare

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

Sponsor

Southwest Oncology Group

Samarbetspartners

National Cancer Institute (NCI)

Utredare

  • Studiestol: Lisa Hammond, MD, The University of Texas Health Science Center at San Antonio
  • Studiestol: Charles R. Thomas, MD, OHSU Knight Cancer Institute
  • Studiestol: Charles D. Blanke, MD, FACP, OHSU Knight Cancer Institute
  • Studiestol: Vivek Mehta, MD, Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

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 maj 2005

Primärt slutförande (Faktisk)

1 september 2009

Avslutad studie (Faktisk)

1 maj 2012

Studieregistreringsdatum

Först inskickad

3 maj 2005

Först inskickad som uppfyllde QC-kriterierna

3 maj 2005

Första postat (Uppskatta)

4 maj 2005

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

18 november 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 november 2015

Senast verifierad

1 november 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CDR0000426442
  • U10CA032102 (U.S.S. NIH-anslag/kontrakt)
  • S0414 (Annan identifierare: SWOG)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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