Maintenance After Induction Chemotherapy in Elderly Patients With Advanced Non-small Cell Lung Cancer

NCT ID: NCT01850303

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 632 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-16
• Study Completion Date: 2020-01-31

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.

Conditions

Non Small Cell Lung Cancer (Squamous or Non Squamous)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surveillance

Group Type: OTHER

Induction chemotherapy

Intervention Type: DRUG

4 cycles of carboplatin-paclitaxel

Maintenance

Pemetrexed for non squamous NSCLC Gemcitabine for squamous NSCLC

Group Type: EXPERIMENTAL

Pemetrexed

Intervention Type: DRUG

Gemcitabine

Intervention Type: DRUG

Induction chemotherapy

Intervention Type: DRUG

4 cycles of carboplatin-paclitaxel

Interventions

Pemetrexed

Intervention Type: DRUG

Gemcitabine

Intervention Type: DRUG

Induction chemotherapy

4 cycles of carboplatin-paclitaxel

Intervention Type: DRUG

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

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intergroupe Francophone de Cancerologie Thoracique

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Besançon, , France

Blois - CH

Blois, , France

APHP - CHU Avicenne - Oncologie Medicale

Bobigny, , France

CH Pierre Oudot

Bourgoin, , 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

Lyon - Clinique Mutualiste

Lyon, , 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, , 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, , 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

Paris - Saint Louis

Paris, , France

Hopital Tenon - Pneumologie

Paris, , France

GH Paris Saint-Joseph

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, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 21831418 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32898792 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Related Links

http://www.ifct.fr

IFCT official website

Other Identifiers

IFCT-1201

Identifier Type: -

Identifier Source: org_study_id