Study of Pemetrexed and Carboplatin Compared With Etoposide Carboplatin to Treat Extensive-Stage Small Cell Lung Cancer
NCT ID: NCT00363415
Last Updated: 2009-10-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
908 participants
INTERVENTIONAL
2006-08-31
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 6 cycles
carboplatin
Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
B
etoposide
100 mg/m2, intravenous (IV), days 1-3 x 6 cycles
carboplatin
Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
Interventions
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pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 6 cycles
etoposide
100 mg/m2, intravenous (IV), days 1-3 x 6 cycles
carboplatin
Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Capable of self-care but may be unable to carry out any work activities.
* No prior anticancer therapy for SCLC
Exclusion Criteria
* have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Eli Lilly
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Fayetteville, Arkansas, United States
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Burbank, California, United States
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Poway, California, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Springfield, Illinois, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Scarborough, Maine, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Sparta, New Jersey, United States
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Albuquerque, New Mexico, United States
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Santa Fe, New Mexico, United States
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Chapel Hill, North Carolina, United States
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Concord, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Zanesville, Ohio, United States
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Portland, Oregon, United States
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Dunmore, Pennsylvania, United States
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East Stroudsburg, Pennsylvania, United States
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Ephrata, Pennsylvania, United States
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Media, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Wilkes-Barre, Pennsylvania, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Chattanooga, Tennessee, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Richmond, Virginia, United States
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Everett, Washington, United States
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Madison, Wisconsin, United States
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Bahía Blanca, , Argentina
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Buenos Aires, , Argentina
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Mar del Plata, , Argentina
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Rosario, , Argentina
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Tucumain, , Argentina
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Camperdown, New South Wales, Australia
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Coffs Harbour, New South Wales, Australia
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Port Macquarie, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Brisbane, Queensland, Australia
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Chermisdie, Queensland, Australia
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Redcliffe, Queensland, Australia
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South Brisbane, Queensland, Australia
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Townsville, Queensland, Australia
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Adelaide, South Australia, Australia
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Woodville, South Australia, Australia
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Hobart, Tasmania, Australia
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Frankston, Victoria, Australia
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Geelong, Victoria, Australia
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Wodonga, Victoria, Australia
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Graz, , Austria
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Linz, , Austria
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Vienna, , Austria
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Brussels, , Belgium
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Edegem, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Florianópolis, , Brazil
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Fortaleza, , Brazil
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Jaú, , Brazil
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São Paulo, , Brazil
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Beijing, , China
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Guangzhou, , China
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Shanghai, , China
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Brest, , France
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Caen, , France
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Clichy, , France
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Grenoble, , France
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Lille, , France
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Lyon, , France
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Marseille, , France
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Montpellier, , France
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Borstel, , Germany
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Cologne, , Germany
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Freiburg im Breisgau, , Germany
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Gauting, , Germany
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Großhansdorf, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Hemer, , Germany
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Kassel, , Germany
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Nuremberg, , Germany
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Regensburg, , Germany
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Rostock, , Germany
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Stralsund, , Germany
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Athens, , Greece
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Heraklion, , Greece
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Marousi Attikis, , Greece
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Pylaia/Thessaloniki, , Greece
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Deszk, , Hungary
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Pécs, , Hungary
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Székesfehérvár, , Hungary
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Szombathely, , Hungary
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Törökbálint, , Hungary
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Zalaegerszeg, , Hungary
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Ahmedabad, , India
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Bangalore, , India
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Kolkata, , India
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Ludhiana, , India
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Mumbai, , India
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New Delhi, , India
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Pune, , India
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Trivandrum, , India
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Bergamo, , Italy
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Livorno, , Italy
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Monteforte Irpino, , Italy
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Orbassano, , Italy
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Parma, , Italy
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Ravenna, , Italy
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Rome, , Italy
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San Sisto, , Italy
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's-Hertogenbosch, , Netherlands
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Amsterdam, , Netherlands
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Arnhem, , Netherlands
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Groningen, , Netherlands
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Harderwijk, , Netherlands
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Heerlen, , Netherlands
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Auckland, , New Zealand
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Christchurch, , New Zealand
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Wellington, , New Zealand
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Gdansk, , Poland
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Krakow-Nowa Huta, , Poland
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Otwock, , Poland
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Szczecin-Zdunowo, , Poland
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Zabrze-Biskupice, , Poland
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Coimbra, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Santa Maria da Feira, , Portugal
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Vila Nova de Gaia, , Portugal
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San Juan, , Puerto Rico
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Chelyabinsk, , Russia
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Engel's, , Russia
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Kazan', , Russia
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Murmansk, , Russia
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Saint Petersburg, , Russia
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Stavropol, , Russia
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Cape Town, , South Africa
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Durban, , South Africa
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Parktown, , South Africa
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Seoul, , South Korea
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Alicante, , Spain
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Badalona, , Spain
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Barakaldo, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Zaragoza, , Spain
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Niao Sung Hsiang, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Besevler/Ankara, , Turkey (Türkiye)
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Gaziantep, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Samsun, , Turkey (Türkiye)
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Bristol, Avon, United Kingdom
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Truro, Cornwall, United Kingdom
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Chelmsford, Essex, United Kingdom
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Aberdeen, Scotland, United Kingdom
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Glasgow, Scotland, United Kingdom
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Birmingham, West Midlands, United Kingdom
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Wolverhampton, West Midlands, United Kingdom
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Manchester, , United Kingdom
Countries
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References
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Ventz S, Khozin S, Louv B, Sands J, Wen PY, Rahman R, Comment L, Alexander BM, Trippa L. The design and evaluation of hybrid controlled trials that leverage external data and randomization. Nat Commun. 2022 Oct 2;13(1):5783. doi: 10.1038/s41467-022-33192-1.
Socinski MA, Smit EF, Lorigan P, Konduri K, Reck M, Szczesna A, Blakely J, Serwatowski P, Karaseva NA, Ciuleanu T, Jassem J, Dediu M, Hong S, Visseren-Grul C, Hanauske AR, Obasaju CK, Guba SC, Thatcher N. Phase III study of pemetrexed plus carboplatin compared with etoposide plus carboplatin in chemotherapy-naive patients with extensive-stage small-cell lung cancer. J Clin Oncol. 2009 Oct 1;27(28):4787-92. doi: 10.1200/JCO.2009.23.1548. Epub 2009 Aug 31.
Other Identifiers
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H3E-MC-JMHO
Identifier Type: -
Identifier Source: secondary_id
9691
Identifier Type: -
Identifier Source: org_study_id
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