Stage I/II NSCLC Perioperative Chemotherapy

NCT00198354 | Completed Phase 3 DMC

• 1 other identifier: IFCT-0002
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Compare 3-Years survival

  3 years

Secondary Outcomes (1)

• Compare Objective response rate

  6 weeks

Study Arms (4)

A: pre-operative chemotherapy

EXPERIMENTAL

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

Drug: gemcitabine + cisplatine

B: pre-operative chemotherapy

EXPERIMENTAL

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

Drug: gemcitabine + cisplatine

C: peri-operative chemotherapy

EXPERIMENTAL

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

Drug: Paclitaxel + Carboplatine

D: peri-operative chemotherapy

EXPERIMENTAL

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

Drug: Paclitaxel + Carboplatine

Interventions

gemcitabine + cisplatine DRUG

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

A: pre-operative chemotherapy; B: pre-operative chemotherapy

Paclitaxel + Carboplatine DRUG

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

C: peri-operative chemotherapy; D: peri-operative chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically NSCLC stade I or II Resectable disease WHO performance status of 2 or less

You may not qualify if:

• NSCLC stage III or IV

Sponsors & Collaborators

• Intergroupe Francophone de Cancerologie Thoracique: lead

Study Sites (1)

CHU Besancon - Pneumologie

Besançon, 25000, France

Location

Related Publications (4)

• 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.

  PMID: 23735703 RESULT

• 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.

  PMID: 22434665 RESULT

• 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.

  PMID: 22722786 RESULT

• 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.

  PMID: 22411898 RESULT

Related Links

• Official website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Alain Depierre, Pr

  Intergroupe Francophone de Cancerologie Thoracique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: May 1, 2001
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: March 10, 2016

Record last verified: 2016-03

Locations

FR (1)