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For elderly patient, the treatment of Non Small Cell Lung Cancer was based on monotherapy but IFCT-0501 trial begun in 2006, demonstrated that a bitherapy (carboplatin and paclitaxel) is better than monotherapy in term of overall survival and progression free survival. The current recommendations are now to administer a carboplatin based bitherapy (4 or 6 cycles). After the treatment is stopped until progression and initiation of a second line treatment. The risk of this strategy is to be confronted to a rapid disease progression during the free interval. Indeed, about 1/3 of the patients whose disease was controlled after the chemotherapy do not receive 2nd line. The concept of maintenance is based on a continuous therapeutic pressure in order to preserve the therapeutic profit obtained by the treatment of 1st line (induction chemotherapy).
There is two types of maintenance :
Gemcitabine has a good tolerance profile which make possible the use in a maintenance strategy. Several trials evaluated maintenance with this product and some show benefits in term of progression free survival.
The objective of this trial is to evaluate the switch maintenance in elderly patient with a controlled disease after 4 cycles of chemotherapy carboplatin-paclitaxel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surveillance | Other |
| |
| Maintenance | Experimental | Pemetrexed for non squamous NSCLC Gemcitabine for squamous NSCLC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemetrexed | Drug |
| ||
| Gemcitabine |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Up to 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of treatment (number of cycles of maintenance) | Number of cycles of maintenance (median) | 84 days on average |
| Progression free survival | up to 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbeville - CH | Abbeville | 80142 | France | |||
| Centre Hospitalier du Pays d'Aix |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21831418 | Background | Quoix E, Zalcman G, Oster JP, Westeel V, Pichon E, Lavole A, Dauba J, Debieuvre D, Souquet PJ, Bigay-Game L, Dansin E, Poudenx M, Molinier O, Vaylet F, Moro-Sibilot D, Herman D, Bennouna J, Tredaniel J, Ducolone A, Lebitasy MP, Baudrin L, Laporte S, Milleron B; Intergroupe Francophone de Cancerologie Thoracique. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet. 2011 Sep 17;378(9796):1079-88. doi: 10.1016/S0140-6736(11)60780-0. Epub 2011 Aug 8. | |
| 32898792 |
| Label | URL |
|---|---|
| IFCT official website | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 20, 2015 | Jul 22, 2022 |
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|
| Induction chemotherapy | Drug | 4 cycles of carboplatin-paclitaxel |
|
| response and stabilisation duration | up to 7 months |
| Number of patient with at least one adverse event | up to 7 months |
| Treatment duration | Up to 7 months |
| 2nd line response rate | Up to 4 months |
| Number of adverse events | Up to 7 months |
| 2nd line overall survival | Up to 7 months |
| 2nd line progression free survival | Up to 4 months |
| Aix-en-Provence |
| France |
| Amiens - CHU | Amiens | France |
| Clinique de l'Europe | Amiens | France |
| Annecy - CH | Annecy | 74374 | France |
| Auxerre - CH | Auxerre | 89011 | France |
| CH de la Côte Basque | Bayonne | France |
| CHU Besancon - Pneumologie | Besançon | 25000 | France |
| Blois - CH | Blois | 41016 | France |
| APHP - CHU Avicenne - Oncologie Medicale | Bobigny | 93000 | France |
| CH Pierre Oudot | Bourgoin | France |
| Brest - Clinique Pasteur | Brest | France |
| Caen - Centre François Baclesse | Caen | 14000 | France |
| CHU Côte de Nâcre | Caen | France |
| CH Cahors | Cahors | France |
| CH de Cannes | Cannes | France |
| Chauny - CH | Chauny | France |
| Hôpital de Cholet - Pneumologie | Cholet | France |
| Clamart - Hôpital Percy | Clamart | 92140 | France |
| Hôpitral Gabriel Montpied - Pneumologie | Clermont-Ferrand | France |
| CH | Colmar | France |
| CH Compiègne - Pneumologie | Compiègne | France |
| CHI Créteil | Créteil | France |
| CH de Dax | Dax | France |
| CHU Hôpital du Bocage | Dijon | France |
| Foix - CH | Foix | France |
| CHU Grenoble - pneumologie | Grenoble | 38000 | France |
| Saint Omer - CHI | Helfaut | 62570 | France |
| Jonzac - CH | Jonzac | 17500 | France |
| Chartres - CH | Le Coudray | 28630 | France |
| Le Mans - Centre Hospitalier | Le Mans | 72000 | France |
| Institut d'Oncologie Hartmann | Levallois-Perret | France |
| CH de Longjumeau | Longjumeau | France |
| Lorient - CHBS | Lorient | France |
| Lyon - Clinique Mutualiste | Lyon | 69003 | France |
| CH Saint Joseph Saint Luc | Lyon | France |
| Hôpital de la Croix Rousse | Lyon | France |
| Hôpital Louis Pradel | Lyon | France |
| Lyon - Clinique de la Sauvegarde | Lyon | France |
| Lyon - Hôpital Jean Mermoz | Lyon | France |
| Hôpital Ambroise Paré | Marseille | France |
| Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques | Marseille | France |
| Institut Paoli Calmette | Marseille | France |
| Maubeuge - Polyclinique du Parc | Maubeuge | 59600 | France |
| Polyclinique du Val de Sambre | Maubeuge | France |
| CH de Macon | Mâcon | France |
| Metz - Belle Isle | Metz | France |
| Mont de Marsan - CH | Mont-de-Marsan | 40000 | France |
| Montargis - CH | Montargis | France |
| Montbéliard - CH | Montbéliard | France |
| Centre Hospitalier | Montélimar | France |
| Montpellier - CHRU | Montpellier | 34295 | France |
| Mulhouse - CH | Mulhouse | 68000 | France |
| CHU Nancy | Nancy | France |
| Nevers - CH | Nevers | 58033 | France |
| Centre Antoine Lacassagne | Nice | France |
| Orléans - CH | Orléans | 45000 | France |
| Paris - Saint Louis | Paris | 75000 | France |
| Hopital Tenon - Pneumologie | Paris | 75020 | France |
| GH Paris Saint-Joseph | Paris | France |
| CHG de Pau | Pau | France |
| Perpignan - Centre Catalan d'Oncologie | Perpignan | 66000 | France |
| Perpignan - Ch | Perpignan | 66046 | France |
| Lyon Sud | Pierre-Bénite | 69495 | France |
| Rennes - CHU | Rennes | France |
| Roubaix - CH | Roubaix | 59100 | France |
| Saint-Nazaire - Clinique Mutualiste de l'Estuaire | Saint-Nazaire | France |
| Centre Hospitalier | Saint-Quentin | France |
| Strasbourg - NHC | Strasbourg | 63000 | France |
| Suresnes - Hopital Foch | Suresnes | 92151 | France |
| Toulon - CHI | Toulon | 83000 | France |
| Hôpital Larrey - Pneumologie | Toulouse | France |
| Tours - CHU | Tours | 37000 | France |
| Troyes - CH | Troyes | 10000 | France |
| Valenciennes - Clinique | Valenciennes | 59304 | France |
| Vernon - CHI | Vernon | France |
| Versailles - CH | Versailles | 78157 | France |
| CH de Villefranche - Pneumologie | Villefranche | France |
| Result |
| Quoix E, Audigier-Valette C, Lavole A, Molinier O, Westeel V, Barlesi F, Le Treut J, Pichon E, Dauba J, Otto J, Moreau L, Madelaine J, Dumont P, Margery J, Debieuvre D, Renault PA, Pujol JL, Langlais A, Morin F, Moro-Sibilot D, Souquet PJ. Switch maintenance chemotherapy versus observation after carboplatin and weekly paclitaxel doublet chemotherapy in elderly patients with advanced non-small cell lung cancer: IFCT-1201 MODEL trial. Eur J Cancer. 2020 Oct;138:193-201. doi: 10.1016/j.ejca.2020.07.034. Epub 2020 Sep 6. |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial 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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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D000093542 | Gemcitabine |
| D060828 | Induction Chemotherapy |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D012074 | Remission Induction |
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