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

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ClinicalTrials.gov Identifier: NCT01850303
Recruitment Status : Completed
First Posted : May 9, 2013
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique

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.


Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer (Squamous or Non Squamous) Drug: Pemetrexed Drug: Gemcitabine Drug: Induction chemotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 632 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : May 16, 2013
Actual Primary Completion Date : August 20, 2018
Actual Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Surveillance Drug: Induction chemotherapy
4 cycles of carboplatin-paclitaxel

Experimental: Maintenance
Pemetrexed for non squamous NSCLC Gemcitabine for squamous NSCLC
Drug: Pemetrexed
Drug: Gemcitabine
Drug: Induction chemotherapy
4 cycles of carboplatin-paclitaxel




Primary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 15 months ]

Secondary Outcome Measures :
  1. Feasibility of treatment (number of cycles of maintenance) [ Time Frame: 84 days on average ]
    Number of cycles of maintenance (median)

  2. Progression free survival [ Time Frame: up to 7 months ]
  3. response and stabilisation duration [ Time Frame: up to 7 months ]
  4. Number of patient with at least one adverse event [ Time Frame: up to 7 months ]
  5. Treatment duration [ Time Frame: Up to 7 months ]
  6. 2nd line response rate [ Time Frame: Up to 4 months ]
  7. Number of adverse events [ Time Frame: Up to 7 months ]
  8. 2nd line overall survival [ Time Frame: Up to 7 months ]
  9. 2nd line progression free survival [ Time Frame: Up to 4 months ]


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Ages Eligible for Study:   70 Years to 89 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850303


Locations
Show Show 78 study locations
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Additional Information:
Publications:
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Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT01850303    
Other Study ID Numbers: IFCT-1201
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:
Elderly
lung cancer
switch
maintenance
Elderly patients (between 70 and 89 years)
NSCLC
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Pemetrexed
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors