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

16 de novembro de 2015 atualizado por: 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.

Visão geral do estudo

Status

Rescindido

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

22

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Alabama
      • Mobile, Alabama, Estados Unidos, 36652-2144
        • Mobile Infirmary Medical Center
    • Arkansas
      • Little Rock, Arkansas, Estados Unidos, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Berkeley, California, Estados Unidos, 94704
        • Alta Bates Comprehensive Cancer Center
      • Burbank, California, Estados Unidos, 91505
        • Providence Saint Joseph Medical Center - Burbank
      • Burlingame, California, Estados Unidos, 94010
        • Peninsula Medical Center
      • Castro Valley, California, Estados Unidos, 94546
        • Eden Medical Center
      • Greenbrae, California, Estados Unidos, 94904
        • Marin Cancer Institute at Marin General Hospital
      • Greenbrae, California, Estados Unidos, 94904
        • Sutter Health - Western Division Cancer Research Group
      • Hayward, California, Estados Unidos, 94545
        • Saint Rose Hospital
      • Los Angeles, California, Estados Unidos, 90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Oakland, California, Estados Unidos, 94609
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland, California, Estados Unidos, 94602
        • Highland General Hospital
      • Oakland, California, Estados Unidos, 94609
        • CCOP - Bay Area Tumor Institute
      • Palm Springs, California, Estados Unidos, 92262
        • Desert Regional Medical Center Comprehensive Cancer Center
      • Pleasanton, California, Estados Unidos, 94588
        • Valley Care Medical Center
      • Sacramento, California, Estados Unidos, 95817
        • University of California Davis Cancer Center
      • San Francisco, California, Estados Unidos, 94118
        • California Pacific Medical Center - California Campus
      • San Pablo, California, Estados Unidos, 94806
        • Doctors Medical Center - San Pablo Campus
      • Sana Rosa, California, Estados Unidos, 95405
        • CCOP - Santa Rosa Memorial Hospital
      • Vallejo, California, Estados Unidos, 94589
        • Sutter Solano Medical Center
    • Colorado
      • Fort Collins, Colorado, Estados Unidos, 80524
        • Poudre Valley Hospital
    • Florida
      • Lakeland, Florida, Estados Unidos, 33804-5000
        • Watson Clinic, LLC
    • Georgia
      • Augusta, Georgia, Estados Unidos, 30901
        • Augusta Oncology Associates - Walton Way
      • Savannah, Georgia, Estados Unidos, 31403-3089
        • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
      • Savannah, Georgia, Estados Unidos, 31405
        • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
    • Idaho
      • Boise, Idaho, Estados Unidos, 83712
        • St. Luke's Mountain States Tumor Institute - Boise
    • Illinois
      • Springfield, Illinois, Estados Unidos, 62781-0001
        • Regional Cancer Center at Memorial Medical Center
    • Indiana
      • Beech Grove, Indiana, Estados Unidos, 46107
        • St. Francis Hospital and Health Centers - Beech Grove Campus
      • Richmond, Indiana, Estados Unidos, 47374
        • Reid Hospital & Health Care Services, Incorporated
    • Kansas
      • Chanute, Kansas, Estados Unidos, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, Estados Unidos, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, Estados Unidos, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Kansas City, Kansas, Estados Unidos, 66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
      • Kingman, Kansas, Estados Unidos, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Liberal, Kansas, Estados Unidos, 67901
        • Southwest Medical Center
      • Newton, Kansas, Estados Unidos, 67114
        • Cancer Center of Kansas, PA - Newton
      • Parsons, Kansas, Estados Unidos, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt, Kansas, Estados Unidos, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, Estados Unidos, 67042
        • Cancer Center of Kansas, PA - Salina
      • Salina, Kansas, Estados Unidos, 67401
        • Tammy Walker Cancer Center at Salina Regional Health Center
      • Wellington, Kansas, Estados Unidos, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, Estados Unidos, 67214
        • Wesley Medical Center
      • Wichita, Kansas, Estados Unidos, 67203
        • Associates in Womens Health, PA - North Review
      • Wichita, Kansas, Estados Unidos, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, Estados Unidos, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, Estados Unidos, 67214
        • CCOP - Wichita
      • Wichita, Kansas, Estados Unidos, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Winfield, Kansas, Estados Unidos, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40536-0293
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109-0942
        • University of Michigan Comprehensive Cancer Center
      • Battle Creek, Michigan, Estados Unidos, 49017
        • Battle Creek Health System Cancer Care Center
      • Big Rapids, Michigan, Estados Unidos, 49307
        • Mecosta County Medical Center
      • Detroit, Michigan, Estados Unidos, 48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • CCOP - Grand Rapids
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • Lacks Cancer Center at Saint Mary's Health Care
      • Grand Rapids, Michigan, Estados Unidos, 49506
        • Metro Health Hospital
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • Spectrum Health Hospital - Butterworth Campus
      • Holland, Michigan, Estados Unidos, 49423
        • Holland Community Hospital
      • Muskegon, Michigan, Estados Unidos, 49442
        • Hackley Hospital
      • Traverse City, Michigan, Estados Unidos, 49684
        • Munson Medical Center
    • Missouri
      • Kansas City, Missouri, Estados Unidos, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, Estados Unidos, 63110
        • Saint Louis University Cancer Center
      • Springfield, Missouri, Estados Unidos, 65802
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, Estados Unidos, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, Estados Unidos, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • Montana
      • Billings, Montana, Estados Unidos, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, Estados Unidos, 59101
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Billings, Montana, Estados Unidos, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, Estados Unidos, 59101
        • St. Vincent Healthcare Cancer Care Services
      • Billings, Montana, Estados Unidos, 59107-7000
        • Billings Clinic - Downtown
      • Bozeman, Montana, Estados Unidos, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, Estados Unidos, 59701
        • St. James Healthcare Cancer Care
      • Great Falls, Montana, Estados Unidos, 59405
        • Great Falls Clinic - Main Facility
      • Great Falls, Montana, Estados Unidos, 59405
      • Helena, Montana, Estados Unidos, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, Estados Unidos, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, Estados Unidos, 59901
        • Glacier Oncology, PLLC
      • Kalispell, Montana, Estados Unidos, 59901
        • Kalispell Medical Oncology at KRMC
      • Missoula, Montana, Estados Unidos, 59801
        • Community Medical Center
      • Missoula, Montana, Estados Unidos, 59804
        • Guardian Oncology and Center for Wellness
      • Missoula, Montana, Estados Unidos, 59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
      • Missoula, Montana, Estados Unidos, 59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • Nebraska
      • Kearney, Nebraska, Estados Unidos, 68848-1990
        • Good Samaritan Cancer Center at Good Samaritan Hospital
    • New York
      • Rochester, New York, Estados Unidos, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Rochester, New York, Estados Unidos, 14623
        • Interlakes Oncology/Hematology PC
    • North Carolina
      • Goldsboro, North Carolina, Estados Unidos, 27534
        • Wayne Memorial Hospital, Incorporated
    • Ohio
      • Akron, Ohio, Estados Unidos, 44307
        • McDowell Cancer Center at Akron General Medical Center
      • Dayton, Ohio, Estados Unidos, 45428
        • Veterans Affairs Medical Center - Dayton
      • Dayton, Ohio, Estados Unidos, 45405
        • Grandview Hospital
      • Dayton, Ohio, Estados Unidos, 45406
        • Good Samaritan Hospital
      • Dayton, Ohio, Estados Unidos, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton, Ohio, Estados Unidos, 45415
        • Samaritan North Cancer Care Center
      • Dayton, Ohio, Estados Unidos, 45429
        • CCOP - Dayton
      • Findlay, Ohio, Estados Unidos, 45840
        • Blanchard Valley Medical Associates
      • Kettering, Ohio, Estados Unidos, 45429
        • Charles F. Kettering Memorial Hospital
      • Middletown, Ohio, Estados Unidos, 45044
        • Middletown Regional Hospital
      • Troy, Ohio, Estados Unidos, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Xenia, Ohio, Estados Unidos, 45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
    • Oregon
      • Gresham, Oregon, Estados Unidos, 97030
        • Legacy Mount Hood Medical Center
      • Milwaukie, Oregon, Estados Unidos, 97222
        • Providence Milwaukie Hospital
      • Portland, Oregon, Estados Unidos, 97227
        • Northwest Cancer Specialists at Rose Quarter Cancer Center
      • Portland, Oregon, Estados Unidos, 97213-2967
        • Providence Cancer Center at Providence Portland Medical Center
      • Portland, Oregon, Estados Unidos, 97225
        • CCOP - Columbia River Oncology Program
      • Portland, Oregon, Estados Unidos, 97225
        • Providence St. Vincent Medical Center
      • Portland, Oregon, Estados Unidos, 97210
        • Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
      • Portland, Oregon, Estados Unidos, 97227
        • Legacy Emanuel Hospital and Health Center & Children's Hospital
      • Portland, Oregon, Estados Unidos, 97239-3098
        • Oregon Health & Science University Cancer Institute
      • Salem, Oregon, Estados Unidos, 97309-5014
        • Salem Hospital Regional Cancer Care Services
      • Tualatin, Oregon, Estados Unidos, 97062
        • Legacy Meridian Park Hospital
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Charleston, South Carolina, Estados Unidos, 29401
        • Roper St. Francis Cancer Center at Roper Hospital
      • Greenville, South Carolina, Estados Unidos, 29615
        • CCOP - Greenville
    • Tennessee
      • Kingsport, Tennessee, Estados Unidos, 37662
        • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
      • Knoxville, Tennessee, Estados Unidos, 37920-6999
        • U.T. Cancer Institute at University of Tennessee Medical Center
    • Virginia
      • Danville, Virginia, Estados Unidos, 24541
        • Danville Regional Medical Center
      • Norton, Virginia, Estados Unidos, 24273
        • Southwest Virginia Regional Cancer Center
    • Washington
      • Bellingham, Washington, Estados Unidos, 98225
        • St. Joseph Cancer Center
      • Bremerton, Washington, Estados Unidos, 98310
        • Olympic Hematology and Oncology
      • Kennewick, Washington, Estados Unidos, 99336
        • Columbia Basin Hematology
      • Mt. Vernon, Washington, Estados Unidos, 98273
        • Skagit Valley Hospital Cancer Care Center
      • Seattle, Washington, Estados Unidos, 98104
        • Harborview Medical Center
      • Seattle, Washington, Estados Unidos, 98104
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, Estados Unidos, 98104
        • Minor and James Medical, PLLC
      • Seattle, Washington, Estados Unidos, 98112
        • Group Health Central Hospital
      • Seattle, Washington, Estados Unidos, 98122-4307
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Seattle, Washington, Estados Unidos, 98122
        • Polyclinic First Hill
      • Seattle, Washington, Estados Unidos, 98195-6043
        • University Cancer Center at University of Washington Medical Center
      • Spokane, Washington, Estados Unidos, 99202
        • Cancer Care Northwest - Spokane South
      • Vancouver, Washington, Estados Unidos, 98684
        • Northwest Cancer Specialists at Vancouver Cancer Center
      • Vancouver, Washington, Estados Unidos, 98668
        • Southwest Washington Medical Center Cancer Center
      • Wenatchee, Washington, Estados Unidos, 98801-2028
        • Wenatchee Valley Medical Center
    • Wyoming
      • Sheridan, Wyoming, Estados Unidos, 82801
        • Welch Cancer Center at Sheridan Memorial Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Treatment
Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3.
Biológico: 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.
Outros nomes:
  • Erbitux
Medicamento: cisplatin
30mg/m^2, bolus intravenous (IV), on Days 1 & 8 of each cycle.
Outros nomes:
  • Platinol
Medicamento: irinotecan hydrochloride
65mg/m^2, intravenous (IV) over 30 min, on Days 1 & 8 of each cycle.
Outros nomes:
  • CPT-11
Radiação: 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.
Outros nomes:
  • RT
  • TRT

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Overall Survival at 2 Years
Prazo: 0-2 years
Measured from time of registration to date of death due to any cause, or last contact date
0-2 years

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Prazo: 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)
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Southwest Oncology Group

Colaboradores

National Cancer Institute (NCI)

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de maio de 2005

Conclusão Primária (Real)

1 de setembro de 2009

Conclusão do estudo (Real)

1 de maio de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

3 de maio de 2005

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de maio de 2005

Primeira postagem (Estimativa)

4 de maio de 2005

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

18 de novembro de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de novembro de 2015

Última verificação

1 de novembro de 2015

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CDR0000426442
  • U10CA032102 (Concessão/Contrato do NIH dos EUA)
  • S0414 (Outro identificador: SWOG)

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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