Clinical trial · Interventional
Stage I/II NSCLC Perioperative Chemotherapy
Phase III Trial Comparing 2 Chemotherapy Schedules (Preoperative vs Pre and Postoperative) in Stage I and II NSCLC
NCT00198354CI-TRIAL-00021296completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer Stage I and II | Lung Non-Small Cell Carcinoma | PROBABILISTIC | 0.70 |
| Peri-operative Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine + cisplatine | Drug | — | UNRESOLVED |
| Paclitaxel + Carboplatine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- A: pre-operative chemotherapy
- description
- pre-operative chemotherapy (gemcitabine+cisplatine, 4 cycles)
- interventionNames
- Drug: gemcitabine + cisplatine
- type
- EXPERIMENTAL
- label
- B: pre-operative chemotherapy
- description
- pre-operative chemotherapy (paclitaxel+carboplatin, 4 cycles)
- interventionNames
- Drug: gemcitabine + cisplatine
- type
- EXPERIMENTAL
- label
- C: peri-operative chemotherapy
- description
- peri-operative chemotherapy (gemcitabine+cisplatine, 4 cycles)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (4)
- RESULTWesteel 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
- RESULTde 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
- RESULTMouillet 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
- RESULTLevallet 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