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CompletedNCT00198354Updated Mar 10, 2016

Stage I/II NSCLC Perioperative Chemotherapy

A Phase 3 interventional study of gemcitabine + cisplatine and Paclitaxel + Carboplatine in Non-small Cell Lung Cancer Stage I and II and Peri-operative Chemotherapy, sponsored by Intergroupe Francophone de Cancerologie Thoracique. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-03-10.

Sponsored by Intergroupe Francophone de Cancerologie Thoracique · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
530
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

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

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 530 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Intergroupe Francophone de Cancerologie Thoracique is the lead sponsor of 57 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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

Exclusion Criteria:

NSCLC stage III or IV

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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
530 participants (actual)

Study arms

  • Experimental
    A: pre-operative chemotherapy

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

    Drug: gemcitabine + cisplatine

  • Experimental
    B: pre-operative chemotherapy

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

    Drug: gemcitabine + cisplatine

  • Experimental
    C: peri-operative chemotherapy

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

    Drug: Paclitaxel + Carboplatine

  • Experimental
    D: peri-operative chemotherapy

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

    Drug: Paclitaxel + Carboplatine

Interventions

  • Druggemcitabine + cisplatine

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

  • DrugPaclitaxel + Carboplatine

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

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What researchers measure

Primary outcomes

  1. Compare 3-Years survival

    Time frame: 3 years

Secondary outcomes

  1. Compare Objective response rate

    Time frame: 6 weeks

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Study locations

1 site
  • CHU Besancon - Pneumologie
    Besancon, 25000, France
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References and documents

Publications

  • 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. PubMed 23735703 ↗
  • 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. PubMed 22434665 ↗
  • 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. PubMed 22722786 ↗
  • 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. PubMed 22411898 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00198354
Lead sponsor
Intergroupe Francophone de Cancerologie Thoracique
Responsible party
Sponsor
First posted
Sep 20, 2005
Start date
May 2001
Primary completion
Dec 2009
Completion
Dec 2010
Last update
Mar 10, 2016

Study contacts

Alain Depierre, Pr
principal investigator · Intergroupe Francophone de Cancerologie Thoracique

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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