Stage I/II NSCLC Perioperative Chemotherapy

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Bristol-Myers Squibb
Information provided by:
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT00198354
First received: September 13, 2005
Last updated: March 26, 2008
Last verified: December 2005

September 13, 2005
March 26, 2008
May 2001
Not Provided
Compare 3-Years survival [ Time Frame: 3 years ]
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Complete list of historical versions of study NCT00198354 on ClinicalTrials.gov Archive Site
Compare Objective response rate [ Time Frame: 6 weeks ]
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Not Provided
Not Provided
 
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.

Interventional
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
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
530
December 2008
Not Provided

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

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00198354
IFCT-0002
Yes
Not Provided
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