Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study
A Double Blind,Placebo Controlled,Parallel Group,Multicentre,Randomised,Phase Iii Survival Study Comparing ZD1839 (IRESSA™)(250mg Tablet) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients With Advanced NSCLC Who Have Received One Or Two Prior Chemotherapy Regimens And Are Refractory Or Intolerant To Their Most Recent Regimen
2 other identifiers
interventional
1,692
32 countries
211
Brief Summary
This study is being carried out to see if adding ZD1839 to other standard supportive care is more effective than standard supportive care alone for the treatment of patients with NSCLC whose disease has recurred after previous chemotherapy treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2003
211 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 19, 2005
CompletedFirst Posted
Study publicly available on registry
October 21, 2005
CompletedApril 23, 2009
April 1, 2009
October 19, 2005
April 22, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
The primary objective of this study is to compare overall survival for ZD1839 plus best supportive care versus placebo plus best supportive care
Secondary Outcomes (5)
· ZD1839 + BSC versus Placebo + BSC in terms of time to treatment failure
· ZD1839 + BSC versus Placebo + BSC in terms of investigator assessed overall
· objective tumour response (CR + PR)
· ZD1839 + BSC versus Placebo + BSC in terms of tolerability
· ZD1839 + BSC versus Placebo + BSC in terms of quality of life changes
Interventions
Eligibility Criteria
You may qualify if:
- · Life expectancy of at least 8 weeks.
- Histologically or cytologically confirmed non-small cell bronchogenic carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma
- Not suitable for chemotherapy
- WHO Performance status 0,1, 2 or 3
You may not qualify if:
- Newly diagnosed CNS mets
- Less than 1 week since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
- ALT/AST greater than 5 x upper limit of normal
- ANC less than 1.0 x 109/L or platelets less than 100 x 109/L
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (211)
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Capital Federal, Buenos Aires, Argentina
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Bahía Blanca, Argentina
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Buenos Aires, Argentina
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La Plata, Argentina
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Mar del Plata, Argentina
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Rosario, Argentina
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Santa Fe, Argentina
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Concord, New South Wales, Australia
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Potts Point, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Chermside, Queensland, Australia
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South Brisbane, Queensland, Australia
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Ashford, South Australia, Australia
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Woodville, South Australia, Australia
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Melbourne, Victoria, Australia
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Parkville, Victoria, Australia
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Prahran, Victoria, Australia
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Wodonga, Victoria, Australia
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Woodville South, Australia
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Fortaleza, Ceará, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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Sorocaba, São Paulo, Brazil
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Varna, Bulgaria
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Veliko Tarnovo, Bulgaria
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Monoton, New Brunswick, Canada
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Greater Sudbury, Ontario, Canada
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Mississauga, Ontario, Canada
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Newmarket, Ontario, Canada
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Saint Catherines, Ontario, Canada
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Toronto, Ontario, Canada
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York, Ontario, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Ste-Foy, Quebec, Canada
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Various Cities, Chile
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Talinn, Estonia
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Tartu, Estonia
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Heidelberg, Baden-Wurttemberg, Germany
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Muchen, Bavaria, Germany
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Frankfurt am Main, Hesse, Germany
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Münster, North Rhine-Westphalia, Germany
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Bad Segeberg, Schleswig-Holstein, Germany
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Frankfurt, Germany
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Freiburg im Breisgau, Germany
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Gauting, Germany
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Grobhansdorf, Germany
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Hamburg, Germany
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Heidelberg, Germany
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Hemer, Germany
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Mutzschen, Germany
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Athens, Greece
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Heraklion, Greece
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Marousi, Greece
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Thessaloniki, Greece
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Budapest, Hungary
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Debrecen, Hungary
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Deszk, Hungary
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Kecskemét, Hungary
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Mosdós, Hungary
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Mosonmagyaróvár, Hungary
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Pécs, Hungary
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Szeged, Hungary
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Törökbálint, Hungary
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Ujronafj, Hungary
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Zalaegerszeg, Hungary
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Zalaegerszeg-Pozva, Hungary
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India, India
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Karnataka, India
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Kolkata, India
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Vellore, India
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Cork, Cork, Ireland
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Dooradoyle, Limerick, Ireland
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Beaumont Road, Ireland
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Dublin, Ireland
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Elm Park, Ireland
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Daugavpils, Latvia
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Liepāja, Latvia
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Riga, Latvia
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Kaunas, Lithuania
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Vilnius, Lithuania
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George Town, Malaysia
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Kampung Baharu Nilai, Malaysia
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Kuala Lumpur, Malaysia
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Torreón, Coahuila, Mexico
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Durango, Durango, Mexico
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Guadalajara, Jalisco, Mexico
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Monterrey, Neuvo Leon, Mexico
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Mérida, Yucatán, Mexico
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Acapulco, Mexico
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Guadalajara, Mexico
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León, Mexico
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México, Mexico
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Alkmaar, Netherlands
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Amsterdam, Netherlands
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Enschede, Netherlands
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Groningen, Netherlands
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Leiden, Netherlands
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Nieuwegein, Netherlands
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Rotterdam, Netherlands
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Ålesund, Norway
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Bergen, Norway
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Gjettum, Norway
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Hamar, Norway
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Haugesund, Norway
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Kristiansand, Norway
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Nordbyhagen, Norway
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Oslo, Norway
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Skien, Norway
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Stavanger, Norway
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Tromsø, Norway
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Trondheim, Norway
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Various Cities, Peru
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Manila, Philippines
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Pasig, Philippines
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Quezon City, Philippines
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Gdansk, Poland
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Katowice, Poland
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Krakow, Poland
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Lodz, Poland
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Poznan, Poland
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Szczecin, Poland
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Zabrze, Poland
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Bucharest, Romania
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Cluj-Napoca, Romania
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Craiova, Romania
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Iași, Romania
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Timișoara, Romania
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Moscow, Russia
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Saint Petersburg, Russia
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Singapore, Singapore
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Bratislava, Slovakia
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Dolný Kubín, Slovakia
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Kojice, Slovakia
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Martin, Slovakia
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Michalovce, Slovakia
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Nitra, Slovakia
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Nitra-Zobor, Slovakia
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Nové Zámky, Slovakia
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Poprad, Slovakia
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Poprad - Kvetnica, Slovakia
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Prejov, Slovakia
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Trnava, Slovakia
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Žilina, Slovakia
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Västerås, Västmanland County, Sweden
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Gothenburg, Sweden
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Huddinge, Sweden
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Jönköping, Sweden
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Karlstad, Sweden
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Linköping, Sweden
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Lund, Sweden
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Stockholm, Sweden
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Uppsala, Sweden
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Banqiao District, Taipei, Taiwan
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Bangkok, Thailand
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Chiang Mai, Thailand
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Ankara, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Various Cities, Ukraine
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Cambridge, Cambrideshire, United Kingdom
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Exeter, Devon, United Kingdom
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Colchester, Essex, United Kingdom
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Romford, Essex, United Kingdom
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Gorleston-on-Sea, Great Yarmouth, United Kingdom
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Fulwood, Lanc, United Kingdom
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Norwich, Norfolk, United Kingdom
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Nottingham, Northamptonshire, United Kingdom
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Belfast, Northern Ireland, United Kingdom
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Birmingham, West Midlands, United Kingdom
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Aberdeen, United Kingdom
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Birmingham, United Kingdom
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Bradford, United Kingdom
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Brighton, United Kingdom
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Coventry, United Kingdom
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Dundee, United Kingdom
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Essex, United Kingdom
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Glasgow, United Kingdom
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Guildford, United Kingdom
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Gwynedd, United Kingdom
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Harrogate, United Kingdom
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Huddersfield, United Kingdom
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Hull, United Kingdom
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Lancaster, United Kingdom
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Leicester, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Nottingham, United Kingdom
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Oxford, United Kingdom
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Reading, United Kingdom
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Southampton, United Kingdom
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Swansea, United Kingdom
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Wolverhampton, United Kingdom
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York, United Kingdom
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Various Cities, Venezuela
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Oncology Medical Science Direction
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 19, 2005
First Posted
October 21, 2005
Study Start
July 1, 2003
Study Completion
April 1, 2005
Last Updated
April 23, 2009
Record last verified: 2009-04