Stage I/II NSCLC Perioperative Chemotherapy

This study has been completed.
Eli Lilly and Company
Bristol-Myers Squibb
Information provided by:
Intergroupe Francophone de Cancerologie Thoracique Identifier:
First received: September 13, 2005
Last updated: March 26, 2008
Last verified: December 2005

September 13, 2005
March 26, 2008
May 2001
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Complete list of historical versions of study NCT00198354 on Archive Site
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Stage I/II NSCLC Perioperative Chemotherapy
Phase III Trial Comparing 2 Chemotherapy Schedules (Preoperative vs Pre and Postoperative) in Stage I and II NSCLC
The addition of chemotherapy to lung cancer surgery is now considered as the standard of care. Solid data support postoperative chemotherapy but only few results are available in the preoperative setting. To define which timing of perioperative chemotherapy offers the best survival improvement, the IFCT 0002 study is conducted in France.
In this multicenter study, patients are randomized to receive either two preoperative chemotherapy cycles plus two additional preoperative cycles if they respond to chemotherapy, or two preoperative plus two postoperative cycles in case of response.
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-Small Cell Lung Cancer Stage I and II
  • Peri-Operative Chemotherapy
Drug: gemcitabine, paclitaxel, cisplatin, carbopatine
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Westeel V, Quoix E, Puyraveau M, Lavolé A, Braun D, Laporte S, Bigay-Game L, Pujol JL, Ozenne G, Rivière A, Douillard JY, Lebeau B, Debieuvre D, Poudenx M, David P, Molinier O, Zalcman G, Lemarié E, Morin F, Depierre A, Milleron B; Intergroupe Francophone de Cancérologie 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2008
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Inclusion Criteria:

Histologically or cytologically NSCLC stade I or II Resectable disease WHO performance status of 2 or less

Exclusion Criteria:

NSCLC stage III or IV

18 Years to 75 Years
Contact information is only displayed when the study is recruiting subjects
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Intergroupe Francophone de Cancerologie Thoracique
  • Eli Lilly and Company
  • Bristol-Myers Squibb
Principal Investigator: Alain Depierre, Pr IFCT
Intergroupe Francophone de Cancerologie Thoracique
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP