Study Results
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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COMPLETED
PHASE2/PHASE3
152 participants
INTERVENTIONAL
2009-04-30
2016-01-21
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Standard chemotherapy
Standard Chemotherapy
Pemetrexed Cisplatin Schedule : CDDP 75 mg/m² D1, pemetrexed 500 mg/m² D1 D1=D21, 4 cycles
B
Customized treatment
Customized Treatment
Mutated EGFR : Erlotinib 150mg/day (1 year)
Wild-type EGFR or "undetermined" depends on ERCC1 status :
* ERCC1 high : no treatment
* ERCC1 low or undetermined : Pemetrexed Cisplatin, 4 cycles (63 days)
Interventions
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Standard Chemotherapy
Pemetrexed Cisplatin Schedule : CDDP 75 mg/m² D1, pemetrexed 500 mg/m² D1 D1=D21, 4 cycles
Customized Treatment
Mutated EGFR : Erlotinib 150mg/day (1 year)
Wild-type EGFR or "undetermined" depends on ERCC1 status :
* ERCC1 high : no treatment
* ERCC1 low or undetermined : Pemetrexed Cisplatin, 4 cycles (63 days)
Eligibility Criteria
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Inclusion Criteria
* Surgically resected NSCLC with pathological stage II or stage IIIA non-N2 (TNM classification 2008)
* Performance status (PS) = 0 or 1
* 18 years \<= age \< 70 years
* Signed inform consent
Exclusion Criteria
* Previous cancer excepted those treated for more than 5 years and considered cured, basocellular skin carcinoma, carcinoma in situ of uterine cervix
* Inadequate renal or cardiac functions
* Pregnant women
* Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, grade ≥ 2 peripheral neuropathy, peptic ulcer disease, erosive esophagitis or gastritis
18 Years
70 Years
ALL
No
Sponsors
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Intergroupe Francophone de Cancerologie Thoracique
OTHER
Responsible Party
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Principal Investigators
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Jean-Charles SORIA, Pr
Role: PRINCIPAL_INVESTIGATOR
Institut Gustave Roussy (IGR)
Marie Wislez, Pr
Role: PRINCIPAL_INVESTIGATOR
APHP - Hôpital Tenon (Paris)
Locations
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Centre Hospitalier
Aix-en-Provence, , France
Clinique de L'Europe
Amiens, , France
Angers - CHU
Angers, , France
Centre Hospitalier
Béziers, , France
Centre F. Baclesse
Caen, , France
CHU - Pneumologie
Caen, , France
Centre Hospitalier
Chauny, , France
Chevilly Larue - CH
Chevilly-Larue, , France
Hôpital Percy-Armées - Pneumologie
Clamart, , France
Clermont Ferrand - CHU
Clermont-Ferrand, , France
Colmar - CH
Colmar, , France
Dax - CH
Dax, , France
Ermont - Clinique Claude Bernard
Ermont, , France
CHU Grenoble - pneumologie
Grenoble, , France
Le Mans - CHG
Le Mans, , France
Centre Léon Bérard
Lyon, , France
Lyon - Hôpital Louis Pradel (Pneumologie)
Lyon, , France
Mantes La Jolie - CH
Mantes-la-Jolie, , France
APHM - Hôpital Sainte Marguerite
Marseille, , France
Institut Paoli Calmette
Marseille, , France
Metz - Belle Isle
Metz, , France
Mont de Marsan - CH
Mont-de-Marsan, , France
Montpellier - Clinique Clémentville
Montpellier, , France
Mulhouse - CH
Mulhouse, , France
Nancy - Polyclinique Gentilly
Nancy, , France
Nevers - CH
Nevers, , France
Paris - Saint Louis
Paris, , France
APHP - Hopital Tenon - Pneumologie
Paris, , France
Pau - CH
Pau, , France
HCL - Lyon Sud (Pneumologie)
Pierre-Bénite, , France
Reims - CHU
Reims, , France
Rennes - CHU
Rennes, , France
Centre Hospitalier
Saint-Quentin, , France
Nouvel Hopital Civil
Strasbourg, , France
Hôpital Foch
Suresnes, , France
Centre Hospitalier Intercommunal
Toulon, , France
CHU Toulouse - Pneumologie
Toulouse, , France
Clinique Pasteur
Toulouse, , France
Tours - CHU
Tours, , France
Nancy - CHU
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Centre Hospitalier Intercommunal
Villeneuve-Saint-Georges, , France
Countries
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References
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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.
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.
Related Links
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IFCT official website
Other Identifiers
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Eudract : 2008-004939-38
Identifier Type: -
Identifier Source: secondary_id
IFCT-0801
Identifier Type: -
Identifier Source: org_study_id
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