Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

16 november 2015 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

22

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Treatment
Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3.
Biologisch: 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.
Andere namen:
  • Erbitux
Geneesmiddel: cisplatin
30mg/m^2, bolus intravenous (IV), on Days 1 & 8 of each cycle.
Andere namen:
  • Platina
Geneesmiddel: irinotecan hydrochloride
65mg/m^2, intravenous (IV) over 30 min, on Days 1 & 8 of each cycle.
Andere namen:
  • CPT-11
Straling: 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.
Andere namen:
  • RT
  • TRT

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Survival at 2 Years
Tijdsspanne: 0-2 years
Measured from time of registration to date of death due to any cause, or last contact date
0-2 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Southwest Oncology Group

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2005

Primaire voltooiing (Werkelijk)

1 september 2009

Studie voltooiing (Werkelijk)

1 mei 2012

Studieregistratiedata

Eerst ingediend

3 mei 2005

Eerst ingediend dat voldeed aan de QC-criteria

3 mei 2005

Eerst geplaatst (Schatting)

4 mei 2005

Updates van studierecords

Laatste update geplaatst (Schatting)

18 november 2015

Laatste update ingediend die voldeed aan QC-criteria

16 november 2015

Laatst geverifieerd

1 november 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CDR0000426442
  • U10CA032102 (Subsidie/contract van de Amerikaanse NIH)
  • S0414 (Andere identificatie: SWOG)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Slokdarmkanker

Klinische onderzoeken op cetuximab

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Panama

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

Abonneren