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

March 10, 2023 updated by: Intergroupe Francophone de Cancerologie Thoracique

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

632

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Abbeville, France, 80142
        • Abbeville - CH
      • Aix-en-Provence, France
        • Centre Hospitalier du Pays d'Aix
      • Amiens, France
        • Amiens - CHU
      • Amiens, France
        • Clinique de l'Europe
      • Annecy, France, 74374
        • Annecy - CH
      • Auxerre, France, 89011
        • Auxerre - CH
      • Bayonne, France
        • CH de la Côte Basque
      • Besancon, France, 25000
        • CHU Besancon - Pneumologie
      • Blois, France, 41016
        • Blois - CH
      • Bobigny, France, 93000
        • APHP - CHU Avicenne - Oncologie Medicale
      • Bourgoin-Jallieu, France
        • CH Pierre Oudot
      • Brest, France
        • Brest - Clinique Pasteur
      • Caen, France, 14000
        • Caen - Centre François Baclesse
      • Caen, France
        • CHU côte de Nacre
      • Cahors, France
        • CH Cahors
      • Cannes, France
        • CH de Cannes
      • Chauny, France
        • Chauny - CH
      • Cholet, France
        • Hôpital de Cholet - Pneumologie
      • Clamart, France, 92140
        • Clamart - Hôpital Percy
      • Clermont-Ferrand, France
        • Hôpitral Gabriel Montpied - Pneumologie
      • Colmar, France
        • CH
      • Compiègne, France
        • CH Compiègne - Pneumologie
      • Créteil, France
        • CHI Créteil
      • Dax, France
        • CH de Dax
      • Dijon, France
        • CHU Hôpital du Bocage
      • Foix, France
        • Foix - CH
      • Grenoble, France, 38000
        • CHU Grenoble - pneumologie
      • Helfaut, France, 62570
        • Saint Omer - CHI
      • Jonzac, France, 17500
        • Jonzac - CH
      • Le Coudray, France, 28630
        • Chartres - CH
      • Le Mans, France, 72000
        • Le Mans - Centre Hospitalier
      • Levallois-Perret, France
        • Institut d'Oncologie Hartmann
      • Longjumeau, France
        • CH de Longjumeau
      • Lorient, France
        • Lorient - CHBS
      • Lyon, France
        • Lyon - Hôpital Jean Mermoz
      • Lyon, France
        • Hopital de La Croix Rousse
      • Lyon, France
        • Hôpital Louis Pradel
      • Lyon, France, 69003
        • Lyon - Clinique Mutualiste
      • Lyon, France
        • Ch Saint Joseph Saint Luc
      • Lyon, France
        • Lyon - Clinique de la Sauvegarde
      • Macon, France
        • CH de Macon
      • Marseille, France
        • Institut Paoli Calmette
      • Marseille, France
        • Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
      • Marseille, France
        • Hopital Ambroise Pare
      • Maubeuge, France, 59600
        • Maubeuge - Polyclinique du Parc
      • Maubeuge, France
        • Polyclinique du Val de Sambre
      • Metz, France
        • Metz - Belle Isle
      • Mont de Marsan, France, 40000
        • Mont de Marsan - CH
      • Montargis, France
        • Montargis - CH
      • Montbéliard, France
        • Montbéliard - CH
      • Montpellier, France, 34295
        • Montpellier - CHRU
      • Montélimar, France
        • Centre Hospitalier
      • Mulhouse, France, 68000
        • Mulhouse - CH
      • Nancy, France
        • Chu Nancy
      • Nevers, France, 58033
        • Nevers - CH
      • Nice, France
        • Centre Antoine Lacassagne
      • Orléans, France, 45000
        • Orléans - CH
      • Paris, France, 75000
        • Paris - Saint Louis
      • Paris, France, 75020
        • Hopital Tenon - Pneumologie
      • Paris, France
        • GH Paris Saint-Joseph
      • Pau, France
        • CHG de Pau
      • Perpignan, France, 66046
        • Perpignan - Ch
      • Perpignan, France, 66000
        • Perpignan - Centre Catalan d'Oncologie
      • Pierre Bénite, France, 69495
        • Lyon Sud
      • Rennes, France
        • Rennes - CHU
      • Roubaix, France, 59100
        • Roubaix - CH
      • Saint-Nazaire, France
        • Saint-Nazaire - Clinique Mutualiste de l'Estuaire
      • Saint-Quentin, France
        • Centre Hospitalier
      • Strasbourg, France, 63000
        • Strasbourg - NHC
      • Suresnes, France, 92151
        • Suresnes - Hopital Foch
      • Toulon, France, 83000
        • Toulon - CHI
      • Toulouse, France
        • Hôpital Larrey - Pneumologie
      • Tours, France, 37000
        • Tours - CHU
      • Troyes, France, 10000
        • Troyes - CH
      • Valenciennes, France, 59304
        • Valenciennes - Clinique
      • Vernon, France
        • Vernon - CHI
      • Versailles, France, 78157
        • Versailles - CH
      • Villefranche, France
        • CH de Villefranche - Pneumologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 89 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Surveillance
Drug: Induction chemotherapy
4 cycles of carboplatin-paclitaxel
Experimental: Maintenance
Pemetrexed for non squamous NSCLC Gemcitabine for squamous NSCLC
Drug: Gemcitabine
Drug: Pemetrexed
Drug: Induction chemotherapy
4 cycles of carboplatin-paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Up to 15 months
Up to 15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of treatment (number of cycles of maintenance)
Time Frame: 84 days on average
Number of cycles of maintenance (median)
84 days on average
Progression free survival
Time Frame: up to 7 months
up to 7 months
response and stabilisation duration
Time Frame: up to 7 months
up to 7 months
Number of patient with at least one adverse event
Time Frame: up to 7 months
up to 7 months
Treatment duration
Time Frame: Up to 7 months
Up to 7 months
2nd line response rate
Time Frame: Up to 4 months
Up to 4 months
Number of adverse events
Time Frame: Up to 7 months
Up to 7 months
2nd line overall survival
Time Frame: Up to 7 months
Up to 7 months
2nd line progression free survival
Time Frame: Up to 4 months
Up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2013

Primary Completion (Actual)

August 20, 2018

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

May 8, 2013

First Posted (Estimate)

May 9, 2013

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFCT-1201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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