Maintenance After Induction Chemotherapy in Elderly Patients With Advanced Non-small Cell Lung Cancer
MODEL
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.
1 other identifier
interventional
632
1 country
78
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2013
Longer than P75 for phase_3
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2013
CompletedFirst Posted
Study publicly available on registry
May 9, 2013
CompletedStudy Start
First participant enrolled
May 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2020
CompletedMarch 14, 2023
March 1, 2023
5.3 years
April 29, 2013
March 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Up to 15 months
Secondary Outcomes (9)
Feasibility of treatment (number of cycles of maintenance)
84 days on average
Progression free survival
up to 7 months
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
- +4 more secondary outcomes
Study Arms (2)
Surveillance
OTHERMaintenance
EXPERIMENTALPemetrexed for non squamous NSCLC Gemcitabine for squamous NSCLC
Interventions
Eligibility Criteria
You may qualify if:
- 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
- \>Age ≥ 70
- ECOG Performance status : 0, 1 or 2
- Mini-Mental Test Status (MMS) \> 23
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (78)
Abbeville - CH
Abbeville, 80142, France
Centre Hospitalier du Pays d'Aix
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
Related Publications (2)
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.
PMID: 21831418BACKGROUNDQuoix 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.
PMID: 32898792RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2013
First Posted
May 9, 2013
Study Start
May 16, 2013
Primary Completion
August 20, 2018
Study Completion
January 31, 2020
Last Updated
March 14, 2023
Record last verified: 2023-03