Clinical trial NCT01850303: Maintenance After Induction Chemotherapy in Elderly Patients With Advanced Non-small Cell Lung Cancer
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non Small Cell Lung Cancer (Squamous or Non Squamous)
Keywords: Elderly
lung cancer
switch
maintenance
Elderly patients (between 70 and 89 years)
NSCLC
IFCT
Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique
Sponsor class: OTHER
First posted: 2013-05-09
Enrollment: 632
Sex: ALL
Minimum age (years): 70
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: Up to 15 months
Secondary outcomes:
measure: Feasibility of treatment (number of cycles of maintenance)
timeFrame: 84 days on average
measure: Progression free survival
timeFrame: up to 7 months
measure: response and stabilisation duration
timeFrame: up to 7 months
measure: Number of patient with at least one adverse event
timeFrame: up to 7 months
measure: Treatment duration
timeFrame: Up to 7 months
measure: 2nd line response rate
timeFrame: Up to 4 months
measure: Number of adverse events
timeFrame: Up to 7 months
measure: 2nd line overall survival
timeFrame: Up to 7 months
measure: 2nd line progression free survival
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Abbeville
country: France
facility: Abbeville - CH
city: Aix-en-Provence
country: France
facility: Centre Hospitalier du Pays d'Aix
city: Amiens
country: France
facility: Amiens - CHU
city: Amiens
country: France
facility: Clinique de l'Europe
city: Annecy
country: France
facility: Annecy - CH
city: Auxerre
country: France
facility: Auxerre - CH
city: Bayonne
country: France
facility: CH de la Côte Basque
city: Besancon
country: France
facility: CHU Besancon - Pneumologie
city: Blois
country: France
facility: Blois - CH
city: Bobigny
country: France
facility: APHP - CHU Avicenne - Oncologie Medicale
city: Bourgoin-Jallieu
country: France
facility: CH Pierre Oudot
city: Brest
country: France
facility: Brest - Clinique Pasteur
city: Caen
country: France
facility: Caen - Centre François Baclesse
city: Caen
country: France
facility: CHU Côte de Nâcre
city: Cahors
country: France
facility: CH Cahors
city: Cannes
country: France
facility: CH de Cannes
city: Chauny
country: France
facility: Chauny - CH
city: Cholet
country: France
facility: Hôpital de Cholet - Pneumologie
city: Clamart
country: France
facility: Clamart - Hôpital Percy
city: Clermont-Ferrand
country: France
facility: Hôpitral Gabriel Montpied - Pneumologie
city: Colmar
country: France
facility: CH
city: Compiègne
country: France
facility: CH Compiègne - Pneumologie
city: Créteil
country: France
facility: CHI Créteil
city: Dax
country: France
facility: CH de Dax
city: Dijon
country: France
facility: CHU Hôpital du Bocage
city: Foix
country: France
facility: Foix - CH
city: Grenoble
country: France
facility: CHU Grenoble - pneumologie
city: Helfaut
country: France
facility: Saint Omer - CHI
city: Jonzac
country: France
facility: Jonzac - CH
city: Le Coudray
country: France
facility: Chartres - CH
city: Le Mans
country: France
facility: Le Mans - Centre Hospitalier
city: Levallois-Perret
country: France
facility: Institut d'Oncologie Hartmann
city: Longjumeau
country: France
facility: CH de Longjumeau
city: Lorient
country: France
facility: Lorient - CHBS
city: Lyon
country: France
facility: Lyon - Clinique Mutualiste
city: Lyon
country: France
facility: CH Saint Joseph Saint Luc
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Lyon
country: France
facility: Hôpital Louis Pradel
city: Lyon
country: France
facility: Lyon - Clinique de la Sauvegarde
city: Lyon
country: France
facility: Lyon - Hôpital Jean Mermoz
city: Macon
country: France
facility: CH de Macon
city: Marseille
country: France
facility: Hôpital Ambroise Paré
city: Marseille
country: France
facility: Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Maubeuge
country: France
facility: Maubeuge - Polyclinique du Parc
city: Maubeuge
country: France
facility: Polyclinique du Val de Sambre
city: Metz
country: France
facility: Metz - Belle Isle
city: Mont de Marsan
country: France
facility: Mont de Marsan - CH
city: Montargis
country: France
facility: Montargis - CH
city: Montbéliard
country: France
facility: Montbéliard - CH
city: Montpellier
country: France
facility: Montpellier - CHRU
city: Montélimar
country: France
facility: Centre Hospitalier
city: Mulhouse
country: France
facility: Mulhouse - CH
city: Nancy
country: France
facility: CHU Nancy
city: Nevers
country: France
facility: Nevers - CH
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Orléans
country: France
facility: Orléans - CH
city: Paris
country: France
facility: Paris - Saint Louis
city: Paris
country: France
facility: Hopital Tenon - Pneumologie
city: Paris
country: France
facility: GH Paris Saint-Joseph
city: Pau
country: France
facility: CHG de Pau
city: Perpignan
country: France
facility: Perpignan - Centre Catalan d'Oncologie
city: Perpignan
country: France
facility: Perpignan - Ch
city: Pierre Bénite
country: France
facility: Lyon Sud
city: Rennes
country: France
facility: Rennes - CHU
city: Roubaix
country: France
facility: Roubaix - CH
city: Saint-Nazaire
country: France
facility: Saint-Nazaire - Clinique Mutualiste de l'Estuaire
city: Saint-Quentin
country: France
facility: Centre Hospitalier
city: Strasbourg
country: France
facility: Strasbourg - NHC
city: Suresnes
country: France
facility: Suresnes - Hopital Foch
city: Toulon
country: France
facility: Toulon - CHI
city: Toulouse
country: France
facility: Hôpital Larrey - Pneumologie
city: Tours
country: France
facility: Tours - CHU
city: Troyes
country: France
facility: Troyes - CH
city: Valenciennes
country: France
facility: Valenciennes - Clinique
city: Vernon
country: France
facility: Vernon - CHI
city: Versailles
country: France
facility: Versailles - CH
city: Villefranche
country: France
facility: CH de Villefranche - Pneumologie
Study officials:
References:
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.
citation: 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.