Stage I/II NSCLC Perioperative Chemotherapy

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ClinicalTrials.gov Identifier: NCT00198354

Recruitment Status : Completed

First Posted : September 20, 2005

Last Update Posted : March 10, 2016

Sponsor:

Information provided by (Responsible Party):

Intergroupe Francophone de Cancerologie Thoracique

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Non-small Cell Lung Cancer Stage I and II Peri-operative Chemotherapy	Drug: gemcitabine + cisplatine Drug: Paclitaxel + Carboplatine	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	530 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	May 2001
Actual Primary Completion Date :	December 2009
Actual Study Completion Date :	December 2010

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Lung cancer

Drug Information available for: Paclitaxel Gemcitabine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: A: pre-operative chemotherapy pre-operative chemotherapy (gemcitabine+cisplatine, 4 cycles)	Drug: gemcitabine + cisplatine gemcitabine 1250 mg/m², D1+D8 cisplatine 80 mg/m², D1 (D1=D22)
Experimental: B: pre-operative chemotherapy pre-operative chemotherapy (paclitaxel+carboplatin, 4 cycles)	Drug: gemcitabine + cisplatine gemcitabine 1250 mg/m², D1+D8 cisplatine 80 mg/m², D1 (D1=D22)
Experimental: C: peri-operative chemotherapy peri-operative chemotherapy (gemcitabine+cisplatine, 4 cycles)	Drug: Paclitaxel + Carboplatine paclitaxel 200 mg/m², D1 carboplatin AUC 6, D1 (D1=D22)
Experimental: D: peri-operative chemotherapy peri-operative chemotherapy (paclitaxel+carboplatin, 4 cycles)	Drug: Paclitaxel + Carboplatine paclitaxel 200 mg/m², D1 carboplatin AUC 6, D1 (D1=D22)

Outcome Measures

Primary Outcome Measures :

Compare 3-Years survival [ Time Frame: 3 years ]

Secondary Outcome Measures :

Compare Objective response rate [ Time Frame: 6 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198354

Locations

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France
CHU Besancon - Pneumologie
Besancon, France, 25000

Sponsors and Collaborators

Intergroupe Francophone de Cancerologie Thoracique

Investigators

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Principal Investigator:	Alain Depierre, Pr	IFCT

More Information

Additional Information:

Official website This link exits the ClinicalTrials.gov site

Publications of Results:

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.

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 Cancérologie 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, Ducoloné A, Molinier O, Zalcman G, Depierre A, Westeel V; Intergroupe Francophone de Cancérologie 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 Cancérologie 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.

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Responsible Party:	Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:	NCT00198354
Other Study ID Numbers:	IFCT-0002
First Posted:	September 20, 2005 Key Record Dates
Last Update Posted:	March 10, 2016
Last Verified:	March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Additional relevant MeSH terms:

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Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Paclitaxel Carboplatin Antineoplastic Agents, Phytogenic	Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs

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