Study Results
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Basic Information
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COMPLETED
PHASE3
530 participants
INTERVENTIONAL
2001-05-31
2010-12-31
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: pre-operative chemotherapy
pre-operative chemotherapy (gemcitabine+cisplatine, 4 cycles)
gemcitabine + cisplatine
gemcitabine 1250 mg/m², D1+D8 cisplatine 80 mg/m², D1 (D1=D22)
B: pre-operative chemotherapy
pre-operative chemotherapy (paclitaxel+carboplatin, 4 cycles)
gemcitabine + cisplatine
gemcitabine 1250 mg/m², D1+D8 cisplatine 80 mg/m², D1 (D1=D22)
C: peri-operative chemotherapy
peri-operative chemotherapy (gemcitabine+cisplatine, 4 cycles)
Paclitaxel + Carboplatine
paclitaxel 200 mg/m², D1 carboplatin AUC 6, D1 (D1=D22)
D: peri-operative chemotherapy
peri-operative chemotherapy (paclitaxel+carboplatin, 4 cycles)
Paclitaxel + Carboplatine
paclitaxel 200 mg/m², D1 carboplatin AUC 6, D1 (D1=D22)
Interventions
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gemcitabine + cisplatine
gemcitabine 1250 mg/m², D1+D8 cisplatine 80 mg/m², D1 (D1=D22)
Paclitaxel + Carboplatine
paclitaxel 200 mg/m², D1 carboplatin AUC 6, D1 (D1=D22)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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Intergroupe Francophone de Cancerologie Thoracique
OTHER
Responsible Party
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Principal Investigators
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Alain Depierre, Pr
Role: PRINCIPAL_INVESTIGATOR
Intergroupe Francophone de Cancerologie Thoracique
Locations
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CHU Besancon - Pneumologie
Besançon, , France
Countries
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References
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Westeel V, Quoix E, Puyraveau M, Lavole A, Braun D, Laporte S, Bigay-Game L, Pujol JL, Ozenne G, Riviere A, Douillard JY, Lebeau B, Debieuvre D, Poudenx M, David P, Molinier O, Zalcman G, Lemarie E, Morin F, Depierre A, Milleron B; Intergroupe Francophone de Cancerologie Thoracique. A randomised trial comparing preoperative to perioperative chemotherapy in early-stage non-small-cell lung cancer (IFCT 0002 trial). Eur J Cancer. 2013 Aug;49(12):2654-64. doi: 10.1016/j.ejca.2013.04.013. Epub 2013 Jun 1.
de Fraipont F, Levallet G, Creveuil C, Bergot E, Beau-Faller M, Mounawar M, Richard N, Antoine M, Rouquette I, Favrot MC, Debieuvre D, Braun D, Westeel V, Quoix E, Brambilla E, Hainaut P, Moro-Sibilot D, Morin F, Milleron B, Zalcman G; Intergroupe Francophone de Cancerologie Thoracique. An apoptosis methylation prognostic signature for early lung cancer in the IFCT-0002 trial. Clin Cancer Res. 2012 May 15;18(10):2976-86. doi: 10.1158/1078-0432.CCR-11-2797. Epub 2012 Mar 20.
Mouillet G, Monnet E, Milleron B, Puyraveau M, Quoix E, David P, Ducolone A, Molinier O, Zalcman G, Depierre A, Westeel V; Intergroupe Francophone de Cancerologie Thoracique (IFCT). Pathologic complete response to preoperative chemotherapy predicts cure in early-stage non-small-cell lung cancer: combined analysis of two IFCT randomized trials. J Thorac Oncol. 2012 May;7(5):841-9. doi: 10.1097/JTO.0b013e31824c7d92.
Levallet G, Bergot E, Antoine M, Creveuil C, Santos AO, Beau-Faller M, de Fraipont F, Brambilla E, Levallet J, Morin F, Westeel V, Wislez M, Quoix E, Debieuvre D, Dubois F, Rouquette I, Pujol JL, Moro-Sibilot D, Camonis J, Zalcman G; Intergroupe Francophone de Cancerologie Thoracique (IFCT). High TUBB3 expression, an independent prognostic marker in patients with early non-small cell lung cancer treated by preoperative chemotherapy, is regulated by K-Ras signaling pathway. Mol Cancer Ther. 2012 May;11(5):1203-13. doi: 10.1158/1535-7163.MCT-11-0899. Epub 2012 Mar 12.
Related Links
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Official website
Other Identifiers
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IFCT-0002
Identifier Type: -
Identifier Source: org_study_id
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