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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract : 2008-004939-38 |
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Our hypothesis is that patients receiving therapy based on their baseline tumor ERCC1 levels and EGFR mutations would attain better disease free survival rates than patients in the control arm receiving noncustomized therapy. Using this selective approach, patients with stage II and IIIA non N2 NSCLC in the genotypic arm with low ERCC1 levels will receive cisplatin plus pemetrexed, and those with high ERCC1 levels will not receive cisplatin-based chemotherapy. If they harbor EGRF mutations they will be treated with erlotinib.
The study will be restricted to non-squamous NSCLC for two mains reasons. First, this will enrich the EGFR mutation rate that is awaited to be higher in these tumors than in squamous cell carcinoma. Second, permetrexed cisplatin combination has a promising efficacy and favorable toxicity profile and is of potential interest in the adjuvant setting of resected non-squamous NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Standard chemotherapy |
|
| B | Experimental | Customized treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Chemotherapy | Drug | Pemetrexed Cisplatin Schedule : CDDP 75 mg/m² D1, pemetrexed 500 mg/m² D1 D1=D21, 4 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility (% of patients having started the treatment before 2 months after the surgery, with the biological results EGFR and ERCC1) | week |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival | month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Charles SORIA, Pr | Institut Gustave Roussy (IGR) | Principal Investigator |
| Marie Wislez, Pr | APHP - Hôpital Tenon (Paris) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier | Aix-en-Provence | France | ||||
| Clinique de L'Europe |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24638013 | Result | Wislez M, Barlesi F, Besse B, Mazieres J, Merle P, Cadranel J, Audigier-Valette C, Moro-Sibilot D, Gautier-Felizot L, Goupil F, Renault A, Quoix E, Souquet PJ, Madroszyck A, Corre R, Perol D, Morin F, Zalcman G, Soria JC. Customized adjuvant phase II trial in patients with non-small-cell lung cancer: IFCT-0801 TASTE. J Clin Oncol. 2014 Apr 20;32(12):1256-61. doi: 10.1200/JCO.2013.53.1525. Epub 2014 Mar 17. | |
| 38428265 |
| Label | URL |
|---|---|
| IFCT official website | View source |
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| Customized Treatment | Drug | Mutated EGFR : Erlotinib 150mg/day (1 year) Wild-type EGFR or "undetermined" depends on ERCC1 status :
|
|
| Amiens |
| France |
| Angers - CHU | Angers | 49000 | France |
| Centre Hospitalier | Béziers | France |
| Centre F. Baclesse | Caen | 14000 | France |
| CHU - Pneumologie | Caen | 14000 | France |
| Centre Hospitalier | Chauny | France |
| Chevilly Larue - CH | Chevilly-Larue | France |
| Hôpital Percy-Armées - Pneumologie | Clamart | 92140 | France |
| Clermont Ferrand - CHU | Clermont-Ferrand | 63000 | France |
| Colmar - CH | Colmar | 68000 | France |
| Dax - CH | Dax | 40107 | France |
| Ermont - Clinique Claude Bernard | Ermont | France |
| CHU Grenoble - pneumologie | Grenoble | 38000 | France |
| Le Mans - CHG | Le Mans | France |
| Centre Léon Bérard | Lyon | 69000 | France |
| Lyon - Hôpital Louis Pradel (Pneumologie) | Lyon | France |
| Mantes La Jolie - CH | Mantes-la-Jolie | 78200 | France |
| APHM - Hôpital Sainte Marguerite | Marseille | 13000 | France |
| Institut Paoli Calmette | Marseille | France |
| Metz - Belle Isle | Metz | France |
| Mont de Marsan - CH | Mont-de-Marsan | 40000 | France |
| Montpellier - Clinique Clémentville | Montpellier | 34070 | France |
| Mulhouse - CH | Mulhouse | 68000 | France |
| Nancy - Polyclinique Gentilly | Nancy | France |
| Nevers - CH | Nevers | 58033 | France |
| Paris - Saint Louis | Paris | 75000 | France |
| APHP - Hopital Tenon - Pneumologie | Paris | 75020 | France |
| Pau - CH | Pau | 64046 | France |
| HCL - Lyon Sud (Pneumologie) | Pierre-Bénite | 69495 | France |
| Reims - CHU | Reims | 51092 | France |
| Rennes - CHU | Rennes | France |
| Centre Hospitalier | Saint-Quentin | France |
| Nouvel Hopital Civil | Strasbourg | 63000 | France |
| Hôpital Foch | Suresnes | France |
| Centre Hospitalier Intercommunal | Toulon | France |
| CHU Toulouse - Pneumologie | Toulouse | France |
| Clinique Pasteur | Toulouse | France |
| Tours - CHU | Tours | 37000 | France |
| Nancy - CHU | Vandœuvre-lès-Nancy | 54500 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Centre Hospitalier Intercommunal | Villeneuve-Saint-Georges | France |
| Derived |
| Oudart JB, Garinet S, Leger C, Barlesi F, Mazieres J, Jeannin G, Audigier-Valette C, Morot-Sibilot D, Langlais A, Amour E, Mathiot N, Birsen G, Blons H, Wislez M. STK11/LKB1 alterations worsen the poor prognosis of KRAS mutated early-stage non-squamous non-small cell lung carcinoma, results based on the phase 2 IFCT TASTE trial. Lung Cancer. 2024 Apr;190:107508. doi: 10.1016/j.lungcan.2024.107508. Epub 2024 Feb 19. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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