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

Primary Purpose

Non Small Cell Lung Cancer (Squamous or Non Squamous)

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Pemetrexed
Gemcitabine
Induction chemotherapy
Sponsored by
Intergroupe Francophone de Cancerologie Thoracique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer (Squamous or Non Squamous) focused on measuring Elderly, lung cancer, switch, maintenance, Elderly patients (between 70 and 89 years), NSCLC, IFCT

Eligibility Criteria

70 Years - 89 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abbeville - CH
  • Centre Hospitalier du Pays d'Aix
  • Amiens - CHU
  • Clinique de l'Europe
  • Annecy - CH
  • Auxerre - CH
  • CH de la Côte Basque
  • CHU Besancon - Pneumologie
  • Blois - CH
  • APHP - CHU Avicenne - Oncologie Medicale
  • CH Pierre Oudot
  • Brest - Clinique Pasteur
  • Caen - Centre François Baclesse
  • CHU Côte de Nâcre
  • CH Cahors
  • CH de Cannes
  • Chauny - CH
  • Hôpital de Cholet - Pneumologie
  • Clamart - Hôpital Percy
  • Hôpitral Gabriel Montpied - Pneumologie
  • CH
  • CH Compiègne - Pneumologie
  • CHI Créteil
  • CH de Dax
  • CHU Hôpital du Bocage
  • Foix - CH
  • CHU Grenoble - pneumologie
  • Saint Omer - CHI
  • Jonzac - CH
  • Chartres - CH
  • Le Mans - Centre Hospitalier
  • Institut d'Oncologie Hartmann
  • CH de Longjumeau
  • Lorient - CHBS
  • Lyon - Clinique Mutualiste
  • CH Saint Joseph Saint Luc
  • Hôpital de la Croix Rousse
  • Hôpital Louis Pradel
  • Lyon - Clinique de la Sauvegarde
  • Lyon - Hôpital Jean Mermoz
  • CH de Macon
  • Hôpital Ambroise Paré
  • Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
  • Institut Paoli Calmette
  • Maubeuge - Polyclinique du Parc
  • Polyclinique du Val de Sambre
  • Metz - Belle Isle
  • Mont de Marsan - CH
  • Montargis - CH
  • Montbéliard - CH
  • Montpellier - CHRU
  • Centre Hospitalier
  • Mulhouse - CH
  • CHU Nancy
  • Nevers - CH
  • Centre Antoine Lacassagne
  • Orléans - CH
  • Paris - Saint Louis
  • Hopital Tenon - Pneumologie
  • GH Paris Saint-Joseph
  • CHG de Pau
  • Perpignan - Centre Catalan d'Oncologie
  • Perpignan - Ch
  • Lyon Sud
  • Rennes - CHU
  • Roubaix - CH
  • Saint-Nazaire - Clinique Mutualiste de l'Estuaire
  • Centre Hospitalier
  • Strasbourg - NHC
  • Suresnes - Hopital Foch
  • Toulon - CHI
  • Hôpital Larrey - Pneumologie
  • Tours - CHU
  • Troyes - CH
  • Valenciennes - Clinique
  • Vernon - CHI
  • Versailles - CH
  • CH de Villefranche - Pneumologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Surveillance

Maintenance

Arm Description

Pemetrexed for non squamous NSCLC Gemcitabine for squamous NSCLC

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Feasibility of treatment (number of cycles of maintenance)
Number of cycles of maintenance (median)
Progression free survival
response and stabilisation duration
Number of patient with at least one adverse event
Treatment duration
2nd line response rate
Number of adverse events
2nd line overall survival
2nd line progression free survival

Full Information

First Posted
April 29, 2013
Last Updated
March 10, 2023
Sponsor
Intergroupe Francophone de Cancerologie Thoracique
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1. Study Identification

Unique Protocol Identification Number
NCT01850303
Brief Title
Maintenance After Induction Chemotherapy in Elderly Patients With Advanced Non-small Cell Lung Cancer
Acronym
MODEL
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 16, 2013 (Actual)
Primary Completion Date
August 20, 2018 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intergroupe Francophone de Cancerologie Thoracique

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer (Squamous or Non Squamous)
Keywords
Elderly, lung cancer, switch, maintenance, Elderly patients (between 70 and 89 years), NSCLC, IFCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
632 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surveillance
Arm Type
Other
Arm Title
Maintenance
Arm Type
Experimental
Arm Description
Pemetrexed for non squamous NSCLC Gemcitabine for squamous NSCLC
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Type
Drug
Intervention Name(s)
Induction chemotherapy
Intervention Description
4 cycles of carboplatin-paclitaxel
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
Up to 15 months
Secondary Outcome Measure Information:
Title
Feasibility of treatment (number of cycles of maintenance)
Description
Number of cycles of maintenance (median)
Time Frame
84 days on average
Title
Progression free survival
Time Frame
up to 7 months
Title
response and stabilisation duration
Time Frame
up to 7 months
Title
Number of patient with at least one adverse event
Time Frame
up to 7 months
Title
Treatment duration
Time Frame
Up to 7 months
Title
2nd line response rate
Time Frame
Up to 4 months
Title
Number of adverse events
Time Frame
Up to 7 months
Title
2nd line overall survival
Time Frame
Up to 7 months
Title
2nd line progression free survival
Time Frame
Up to 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Abbeville - CH
City
Abbeville
ZIP/Postal Code
80142
Country
France
Facility Name
Centre Hospitalier du Pays d'Aix
City
Aix-en-Provence
Country
France
Facility Name
Amiens - CHU
City
Amiens
Country
France
Facility Name
Clinique de l'Europe
City
Amiens
Country
France
Facility Name
Annecy - CH
City
Annecy
ZIP/Postal Code
74374
Country
France
Facility Name
Auxerre - CH
City
Auxerre
ZIP/Postal Code
89011
Country
France
Facility Name
CH de la Côte Basque
City
Bayonne
Country
France
Facility Name
CHU Besancon - Pneumologie
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Blois - CH
City
Blois
ZIP/Postal Code
41016
Country
France
Facility Name
APHP - CHU Avicenne - Oncologie Medicale
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
CH Pierre Oudot
City
Bourgoin-Jallieu
Country
France
Facility Name
Brest - Clinique Pasteur
City
Brest
Country
France
Facility Name
Caen - Centre François Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
CHU Côte de Nâcre
City
Caen
Country
France
Facility Name
CH Cahors
City
Cahors
Country
France
Facility Name
CH de Cannes
City
Cannes
Country
France
Facility Name
Chauny - CH
City
Chauny
Country
France
Facility Name
Hôpital de Cholet - Pneumologie
City
Cholet
Country
France
Facility Name
Clamart - Hôpital Percy
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
Hôpitral Gabriel Montpied - Pneumologie
City
Clermont-Ferrand
Country
France
Facility Name
CH
City
Colmar
Country
France
Facility Name
CH Compiègne - Pneumologie
City
Compiègne
Country
France
Facility Name
CHI Créteil
City
Créteil
Country
France
Facility Name
CH de Dax
City
Dax
Country
France
Facility Name
CHU Hôpital du Bocage
City
Dijon
Country
France
Facility Name
Foix - CH
City
Foix
Country
France
Facility Name
CHU Grenoble - pneumologie
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Saint Omer - CHI
City
Helfaut
ZIP/Postal Code
62570
Country
France
Facility Name
Jonzac - CH
City
Jonzac
ZIP/Postal Code
17500
Country
France
Facility Name
Chartres - CH
City
Le Coudray
ZIP/Postal Code
28630
Country
France
Facility Name
Le Mans - Centre Hospitalier
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Institut d'Oncologie Hartmann
City
Levallois-Perret
Country
France
Facility Name
CH de Longjumeau
City
Longjumeau
Country
France
Facility Name
Lorient - CHBS
City
Lorient
Country
France
Facility Name
Lyon - Clinique Mutualiste
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
CH Saint Joseph Saint Luc
City
Lyon
Country
France
Facility Name
Hôpital de la Croix Rousse
City
Lyon
Country
France
Facility Name
Hôpital Louis Pradel
City
Lyon
Country
France
Facility Name
Lyon - Clinique de la Sauvegarde
City
Lyon
Country
France
Facility Name
Lyon - Hôpital Jean Mermoz
City
Lyon
Country
France
Facility Name
CH de Macon
City
Macon
Country
France
Facility Name
Hôpital Ambroise Paré
City
Marseille
Country
France
Facility Name
Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
City
Marseille
Country
France
Facility Name
Institut Paoli Calmette
City
Marseille
Country
France
Facility Name
Maubeuge - Polyclinique du Parc
City
Maubeuge
ZIP/Postal Code
59600
Country
France
Facility Name
Polyclinique du Val de Sambre
City
Maubeuge
Country
France
Facility Name
Metz - Belle Isle
City
Metz
Country
France
Facility Name
Mont de Marsan - CH
City
Mont de Marsan
ZIP/Postal Code
40000
Country
France
Facility Name
Montargis - CH
City
Montargis
Country
France
Facility Name
Montbéliard - CH
City
Montbéliard
Country
France
Facility Name
Montpellier - CHRU
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Hospitalier
City
Montélimar
Country
France
Facility Name
Mulhouse - CH
City
Mulhouse
ZIP/Postal Code
68000
Country
France
Facility Name
CHU Nancy
City
Nancy
Country
France
Facility Name
Nevers - CH
City
Nevers
ZIP/Postal Code
58033
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
Country
France
Facility Name
Orléans - CH
City
Orléans
ZIP/Postal Code
45000
Country
France
Facility Name
Paris - Saint Louis
City
Paris
ZIP/Postal Code
75000
Country
France
Facility Name
Hopital Tenon - Pneumologie
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
GH Paris Saint-Joseph
City
Paris
Country
France
Facility Name
CHG de Pau
City
Pau
Country
France
Facility Name
Perpignan - Centre Catalan d'Oncologie
City
Perpignan
ZIP/Postal Code
66000
Country
France
Facility Name
Perpignan - Ch
City
Perpignan
ZIP/Postal Code
66046
Country
France
Facility Name
Lyon Sud
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Rennes - CHU
City
Rennes
Country
France
Facility Name
Roubaix - CH
City
Roubaix
ZIP/Postal Code
59100
Country
France
Facility Name
Saint-Nazaire - Clinique Mutualiste de l'Estuaire
City
Saint-Nazaire
Country
France
Facility Name
Centre Hospitalier
City
Saint-Quentin
Country
France
Facility Name
Strasbourg - NHC
City
Strasbourg
ZIP/Postal Code
63000
Country
France
Facility Name
Suresnes - Hopital Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
Toulon - CHI
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Name
Hôpital Larrey - Pneumologie
City
Toulouse
Country
France
Facility Name
Tours - CHU
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Troyes - CH
City
Troyes
ZIP/Postal Code
10000
Country
France
Facility Name
Valenciennes - Clinique
City
Valenciennes
ZIP/Postal Code
59304
Country
France
Facility Name
Vernon - CHI
City
Vernon
Country
France
Facility Name
Versailles - CH
City
Versailles
ZIP/Postal Code
78157
Country
France
Facility Name
CH de Villefranche - Pneumologie
City
Villefranche
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21831418
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.
Results Reference
background
PubMed Identifier
32898792
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.
Results Reference
result
Links:
URL
http://www.ifct.fr
Description
IFCT official website

Learn more about this trial

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

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