Non Small Cell Lung Cancer (Squamous or Non Squamous) Clinical Trial
— MODELOfficial title:
Phase III Study Comparing Maintenance With Pemetrexed or Gemcitabine to a Surveillance in Elderly Patients (70 Years Old and More) With a Advanced Non Small Cell Lung Cancer Controlled by Induction Chemotherapy.
| Verified date | March 2023 |
| Source | Intergroupe Francophone de Cancerologie Thoracique |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 : - continuous maintenance therapy which consists in continuing the treatment initially associated with platinum until disease progression. - switch maintenance which consists in introducing a new treatment after the end of induction chemotherapy The two types are validated by several trials. The marketing authorization of pemetrexed was enlarged to maintenance for non squamous carcinoma. 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.
| Status | Completed |
| Enrollment | 632 |
| Est. completion date | January 31, 2020 |
| Est. primary completion date | August 20, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 70 Years to 89 Years |
| Eligibility | Inclusion Criteria: - Histologically or cytologically documented Non Small Cell Lung Cancer non resectable or non irradiable stage III or stage IV - EGFR wild type or non feasible EGFR - 90 >Age = 70 - ECOG Performance status : 0, 1 or 2 - Mini-Mental Test Status (MMS) > 23 Exclusion Criteria: - Mixed non-small cell and small cell tumors - Patients with EGFR mutated tumor - Patient with EML4-ALK translocation - Evolutive or symptomatic metastasis of central nervous system - Superior vena cava syndrome - Calcemia > 2,70 mmol/L |
| Country | Name | City | State |
|---|---|---|---|
| France | Abbeville - CH | Abbeville | |
| France | Centre Hospitalier du Pays d'Aix | Aix-en-Provence | |
| France | Amiens - CHU | Amiens | |
| France | Clinique de l'Europe | Amiens | |
| France | Annecy - CH | Annecy | |
| France | Auxerre - CH | Auxerre | |
| France | CH de la Côte Basque | Bayonne | |
| France | CHU Besancon - Pneumologie | Besancon | |
| France | Blois - CH | Blois | |
| France | APHP - CHU Avicenne - Oncologie Medicale | Bobigny | |
| France | CH Pierre Oudot | Bourgoin-Jallieu | |
| France | Brest - Clinique Pasteur | Brest | |
| France | Caen - Centre François Baclesse | Caen | |
| 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 | |
| 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 | |
| France | Saint Omer - CHI | Helfaut | |
| France | Jonzac - CH | Jonzac | |
| France | Chartres - CH | Le Coudray | |
| France | Le Mans - Centre Hospitalier | Le Mans | |
| France | Institut d'Oncologie Hartmann | Levallois-Perret | |
| France | CH de Longjumeau | Longjumeau | |
| France | Lorient - CHBS | Lorient | |
| 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 - Clinique Mutualiste | Lyon | |
| France | Lyon - Hôpital Jean Mermoz | Lyon | |
| France | CH de Macon | Macon | |
| France | Hôpital Ambroise Paré | Marseille | |
| France | Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques | Marseille | |
| France | Institut Paoli Calmette | Marseille | |
| France | Maubeuge - Polyclinique du Parc | Maubeuge | |
| France | Polyclinique du Val de Sambre | Maubeuge | |
| France | Metz - Belle Isle | Metz | |
| France | Mont de Marsan - CH | Mont de Marsan | |
| France | Montargis - CH | Montargis | |
| France | Montbéliard - CH | Montbéliard | |
| France | Centre Hospitalier | Montélimar | |
| France | Montpellier - CHRU | Montpellier | |
| France | Mulhouse - CH | Mulhouse | |
| France | CHU Nancy | Nancy | |
| France | Nevers - CH | Nevers | |
| France | Centre Antoine Lacassagne | Nice | |
| France | Orléans - CH | Orléans | |
| France | GH Paris Saint-Joseph | Paris | |
| France | Hopital Tenon - Pneumologie | Paris | |
| France | Paris - Saint Louis | Paris | |
| France | CHG de Pau | Pau | |
| France | Perpignan - Centre Catalan d'Oncologie | Perpignan | |
| France | Perpignan - Ch | Perpignan | |
| France | Lyon Sud | Pierre Bénite | |
| France | Rennes - CHU | Rennes | |
| France | Roubaix - CH | Roubaix | |
| France | Saint-Nazaire - Clinique Mutualiste de l'Estuaire | Saint-Nazaire | |
| France | Centre Hospitalier | Saint-Quentin | |
| France | Strasbourg - NHC | Strasbourg | |
| France | Suresnes - Hopital Foch | Suresnes | |
| France | Toulon - CHI | Toulon | |
| France | Hôpital Larrey - Pneumologie | Toulouse | |
| France | Tours - CHU | Tours | |
| France | Troyes - CH | Troyes | |
| France | Valenciennes - Clinique | Valenciennes | |
| France | Vernon - CHI | Vernon | |
| France | Versailles - CH | Versailles | |
| France | CH de Villefranche - Pneumologie | Villefranche |
| Lead Sponsor | Collaborator |
|---|---|
| Intergroupe Francophone de Cancerologie Thoracique |
France,
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 maintena — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall survival | Up to 15 months | ||
| Secondary | Feasibility of treatment (number of cycles of maintenance) | Number of cycles of maintenance (median) | 84 days on average | |
| Secondary | Progression free survival | up to 7 months | ||
| Secondary | response and stabilisation duration | up to 7 months | ||
| Secondary | Number of patient with at least one adverse event | up to 7 months | ||
| Secondary | Treatment duration | Up to 7 months | ||
| Secondary | 2nd line response rate | Up to 4 months | ||
| Secondary | Number of adverse events | Up to 7 months | ||
| Secondary | 2nd line overall survival | Up to 7 months | ||
| Secondary | 2nd line progression free survival | Up to 4 months |