- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00087711
Randomizovaná studie fáze 3 pemetrexedu a cisplatiny versus gemcitabin a cisplatina u pacientů s lokálně pokročilým nebo metastatickým nemalobuněčným karcinomem plic
10. září 2019 aktualizováno: Eli Lilly and Company
Randomizovaná studie fáze 3 ALIMTA a cisplatina versus GEMZAR a cisplatina u pacientů s lokálně pokročilým nebo metastatickým nemalobuněčným karcinomem plic
Tato studie je randomizovanou studií fáze 3 srovnávající kombinaci pemetrexedu a cisplatiny s gemcitabinem a cisplatinou pro léčbu nemalobuněčného karcinomu plic (NCSLC).
Gemcitabin plus cisplatina je v současnosti standardem péče o NSCLC.
Předpokládá se, že pemetrexed plus cisplatina mohou být stejně účinné a mohou mít méně nežádoucích účinků než standardní péče.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
1713
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Bahia Blanca, Argentina
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Buenos Aires, Argentina
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Bedford Park, Austrálie
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Camperdown, Austrálie
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Chermisdie, Austrálie
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Fitzroy, Austrálie
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Hornsby, Austrálie
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Nedlands, Austrálie
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South Brisbane, Austrálie
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St Leonards, Austrálie
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Leuven, Belgie
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Liege, Belgie
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Florianopolis, Brazílie
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Porto Alegre, Brazílie
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Rio De Janeiro, Brazílie
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Salvador, Brazílie
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Sao Paulo, Brazílie
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Herlev, Dánsko
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Odense, Dánsko
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Helsinki, Finsko
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Tampere, Finsko
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Bordeaux, Francie
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Grenoble, Francie
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Marseille, Francie
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Montpellier, Francie
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Paris, Francie
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Saint Herblain, Francie
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Strasbourg, Francie
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Vandoeuvre-les-Nancy, Francie
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Alkmaar, Holandsko
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Amstelveen, Holandsko
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Amsterdam, Holandsko
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Arnhem, Holandsko
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Den Bosch, Holandsko
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Eindhoven, Holandsko
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Harderwijk, Holandsko
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Heerlen, Holandsko
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Bangalore, Indie
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Cochin, Indie
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Hyderabad, Indie
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Mumbai, Indie
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New Dehli, Indie
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Pune, Indie
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Ancona, Itálie
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Bergamo, Itálie
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Bologna, Itálie
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Forli, Itálie
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Genova, Itálie
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Livorno, Itálie
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Modena, Itálie
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Orbassano, Itálie
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Roma, Itálie
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Taormina, Itálie
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Kfar Saba, Izrael
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Tel-Aviv, Izrael
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Tel-Hashomer, Izrael
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British Columbia
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North Vancouver, British Columbia, Kanada
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Ontario
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Brampton, Ontario, Kanada
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Toronto, Ontario, Kanada
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Quebec
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Sainte-Foy, Quebec, Kanada
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Goyang-Si, Korejská republika
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Seoul, Korejská republika
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Ankara, Krocan
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Antalya, Krocan
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Istanbul, Krocan
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Izmir, Krocan
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Budapest, Maďarsko
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Deszk, Maďarsko
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Pecs, Maďarsko
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Ciudad Obregon, Mexiko
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Guadalajara, Mexiko
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Leon, Mexiko
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Mexicali, Mexiko
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Mexico City, Mexiko
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Mannheim, Německo
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Krakow, Polsko
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Lodz, Polsko
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Szczecin-Zdunowo, Polsko
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Warszawa, Polsko
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San Juan, Portoriko
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Coimbra, Portugalsko
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Lisboa, Portugalsko
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Porto, Portugalsko
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Santa Maria Da Feira, Portugalsko
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Graz, Rakousko
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Grimmenstein, Rakousko
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Innsbruck, Rakousko
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Leoben, Rakousko
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Linz, Rakousko
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
St. Poelten, Rakousko
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Vienna, Rakousko
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Wels, Rakousko
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Aberdeen, Spojené království
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Bangor, Spojené království
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Chelmsford, Spojené království
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Fulham, Spojené království
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Plymouth, Spojené království
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Sutton, Spojené království
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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California
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Sacramento, California, Spojené státy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Torrance, California, Spojené státy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
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Florida
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Jacksonville, Florida, Spojené státy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
-
Georgia
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Macon, Georgia, Spojené státy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
-
Kansas
-
Wichita, Kansas, Spojené státy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
-
Kentucky
-
Lexington, Kentucky, Spojené státy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Maine
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Scarborough, Maine, Spojené státy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
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Minnesota
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Duluth, Minnesota, Spojené státy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
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Missouri
-
Saint Louis, Missouri, Spojené státy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
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Montana
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Billings, Montana, Spojené státy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
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New Jersey
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Hackensack, New Jersey, Spojené státy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
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North Carolina
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Hickory, North Carolina, Spojené státy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
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Oregon
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Portland, Oregon, Spojené státy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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South Carolina
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Columbia, South Carolina, Spojené státy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Tennessee
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Nashville, Tennessee, Spojené státy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Texas
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Arlington, Texas, Spojené státy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
-
Virginia
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Richmond, Virginia, Spojené státy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Washington
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Seattle, Washington, Spojené státy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Niao Sung Hsiang, Tchaj-wan
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Taichung, Tchaj-wan
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Taipei, Tchaj-wan
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Tao-Yuan, Tchaj-wan
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Athens, Řecko
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Heraklion, Řecko
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Patras, Řecko
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Alicante, Španělsko
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Badalona, Španělsko
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Barcelona, Španělsko
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Madrid, Španělsko
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Pamplona, Španělsko
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Sabadell, Španělsko
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Santander, Španělsko
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Zaragoza, Španělsko
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Goteborg, Švédsko
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Lund, Švédsko
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Stockholm, Švédsko
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Kritéria pro zařazení:
- Diagnóza NSCLC fáze IIIB, která není vhodná pro kurativní léčbu nebo stadium IV.
- Žádná předchozí chemoterapie pro rakovinu plic.
- Pacienti musí mít alespoň jednu jednorozměrně měřitelnou lézi.
- Před radiační terapií na méně než 25 % kostní dřeně, celá pánev není povolena. Radiace musí být dokončena alespoň 4 týdny před zápisem do studia.
Kritéria vyloučení:
- Léčba jakýmkoli lékem během posledních 30 dnů, který nezískal regulační povolení.
- Vážný srdeční stav.
- Závažná zdravotní porucha kromě NSCLC, která by pacientovi ztížila dokončení studie.
- Neschopnost nebo neochota užívat jako doplňky kyseliny listové nebo vitaminu B12.
- Přítomnost zadržování tekutin, které nelze kontrolovat drenáží.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Aktivní komparátor: B
|
75 mg/m2, IV, q 21 dní x 6 cyklů
1250 mg/m2, IV, den 1 a 8 q 21 dní x 6 cyklů
Ostatní jména:
|
Experimentální: A
|
500 mg/m2, IV q 21 dní x 6 cyklů
Ostatní jména:
75 mg/m2, IV, q 21 dní x 6 cyklů
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Celkové přežití
Časové okno: výchozí stav k datu úmrtí z jakékoli příčiny
|
výchozí stav k datu úmrtí z jakékoli příčiny
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Délka odezvy
Časové okno: doba reakce na progresivní onemocnění
|
doba reakce na progresivní onemocnění
|
Čas progrese onemocnění
Časové okno: výchozí hodnota k měřenému progresivnímu onemocnění
|
výchozí hodnota k měřenému progresivnímu onemocnění
|
Přežití bez progrese
Časové okno: výchozí hodnota k měřenému progresivnímu onemocnění
|
výchozí hodnota k měřenému progresivnímu onemocnění
|
Čas do selhání léčby
Časové okno: výchozí stav k ukončení léčby
|
výchozí stav k ukončení léčby
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Gridelli C, Brodowicz T, Langer CJ, Peterson P, Islam M, Guba SC, Moore P, Visseren-Grul CM, Scagliotti G. Pemetrexed therapy in elderly patients with good performance status: analysis of two phase III trials of patients with nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2012 Sep;13(5):340-6. doi: 10.1016/j.cllc.2011.12.002. Epub 2012 Jan 23.
- Wu YL, Lu S, Cheng Y, Zhou C, Wang M, Qin S, Lu Y, Zhang Y, Zhu Y, Song X, Wang X, Barraclough H, Zhang X, Chi H, Orlando M. Efficacy and safety of pemetrexed/cisplatin versus gemcitabine/cisplatin as first-line treatment in Chinese patients with advanced nonsquamous non-small cell lung cancer. Lung Cancer. 2014 Sep;85(3):401-7. doi: 10.1016/j.lungcan.2014.07.007. Epub 2014 Jul 17.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. července 2004
Primární dokončení (Aktuální)
1. ledna 2007
Dokončení studie (Aktuální)
1. března 2008
Termíny zápisu do studia
První předloženo
12. července 2004
První předloženo, které splnilo kritéria kontroly kvality
15. července 2004
První zveřejněno (Odhad)
16. července 2004
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
12. září 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
10. září 2019
Naposledy ověřeno
1. září 2019
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Nemoci dýchacích cest
- Novotvary
- Plicní onemocnění
- Novotvary podle místa
- Novotvary dýchacího traktu
- Novotvary hrudníku
- Karcinom, Bronchogenní
- Bronchiální novotvary
- Novotvary plic
- Karcinom, nemalobuněčné plíce
- Fyziologické účinky léků
- Molekulární mechanismy farmakologického působení
- Antiinfekční látky
- Antivirová činidla
- Inhibitory syntézy nukleových kyselin
- Inhibitory enzymů
- Antimetabolity, Antineoplastika
- Antimetabolity
- Antineoplastická činidla
- Imunosupresivní látky
- Imunologické faktory
- Antagonisté kyseliny listové
- Gemcitabin
- Pemetrexed
Další identifikační čísla studie
- 2938
- H3E-MC-JMDB (Jiný identifikátor: Eli Lilly and Company)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Anonymizovaná data na úrovni jednotlivých pacientů budou poskytnuta v prostředí zabezpečeného přístupu po schválení výzkumného návrhu a podepsané dohody o sdílení dat.
Časový rámec sdílení IPD
Údaje jsou k dispozici 6 měsíců po primární publikaci a schválení indikace studované v USA a EU, podle toho, co nastane později.
Data budou k dispozici po neomezenou dobu.
Kritéria přístupu pro sdílení IPD
Návrh výzkumu musí schválit nezávislý hodnotící panel a výzkumní pracovníci musí podepsat dohodu o sdílení dat.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- CSR
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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