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
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.

Condition Intervention Phase
Non-Small Cell Lung Cancer Stage I and II
Peri-Operative Chemotherapy
Drug: gemcitabine, paclitaxel, cisplatin, carbopatine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Trial Comparing 2 Chemotherapy Schedules (Preoperative vs Pre and Postoperative) in Stage I and II NSCLC

Resource links provided by NLM:

Further study details as provided by Intergroupe Francophone de Cancerologie Thoracique:

Primary Outcome Measures:
  • Compare 3-Years survival [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Compare Objective response rate [ Time Frame: 6 weeks ]

Enrollment: 530
Study Start Date: May 2001
Estimated Study Completion Date: December 2008
Detailed Description:
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.

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00198354

CHU Besancon - Pneumologie
Besancon, France, 25000
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Eli Lilly and Company
Bristol-Myers Squibb
Principal Investigator: Alain Depierre, Pr IFCT
  More Information

No publications provided by Intergroupe Francophone de Cancerologie Thoracique

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00198354     History of Changes
Other Study ID Numbers: IFCT-0002 
Study First Received: September 13, 2005
Last Updated: March 26, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms processed this record on February 08, 2016