Stage I/II NSCLC Perioperative Chemotherapy

NCT ID: NCT00198354

Last Updated: 2016-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

530 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Non-small Cell Lung Cancer Stage I and II Peri-operative Chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A: pre-operative chemotherapy

pre-operative chemotherapy (gemcitabine+cisplatine, 4 cycles)

Group Type EXPERIMENTAL

gemcitabine + cisplatine

Intervention Type DRUG

gemcitabine 1250 mg/m², D1+D8 cisplatine 80 mg/m², D1 (D1=D22)

B: pre-operative chemotherapy

pre-operative chemotherapy (paclitaxel+carboplatin, 4 cycles)

Group Type EXPERIMENTAL

gemcitabine + cisplatine

Intervention Type DRUG

gemcitabine 1250 mg/m², D1+D8 cisplatine 80 mg/m², D1 (D1=D22)

C: peri-operative chemotherapy

peri-operative chemotherapy (gemcitabine+cisplatine, 4 cycles)

Group Type EXPERIMENTAL

Paclitaxel + Carboplatine

Intervention Type DRUG

paclitaxel 200 mg/m², D1 carboplatin AUC 6, D1 (D1=D22)

D: peri-operative chemotherapy

peri-operative chemotherapy (paclitaxel+carboplatin, 4 cycles)

Group Type EXPERIMENTAL

Paclitaxel + Carboplatine

Intervention Type DRUG

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)

Intervention Type DRUG

Paclitaxel + Carboplatine

paclitaxel 200 mg/m², D1 carboplatin AUC 6, D1 (D1=D22)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intergroupe Francophone de Cancerologie Thoracique

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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France

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.

Reference Type RESULT
PMID: 23735703 (View on PubMed)

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.

Reference Type RESULT
PMID: 22434665 (View on PubMed)

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.

Reference Type RESULT
PMID: 22722786 (View on PubMed)

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.

Reference Type RESULT
PMID: 22411898 (View on PubMed)

Related Links

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http://www.ifct.fr

Official website

Other Identifiers

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IFCT-0002

Identifier Type: -

Identifier Source: org_study_id

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