Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.

Last updated: November 26, 2025
Sponsor: Institut Curie
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Metastatic Cancer

Treatment

Optimization of the medical decision

Usual care

Clinical Study ID

NCT04823377
IC 2020-05
  • Ages > 18
  • All Genders

Study Summary

Sequential comparative prospective interventional study evaluating the impact of the use of an optimization device of the decision of cancer treatment on aggressiveness of end of life care. Comparison between a first period, period (A), of care as usual and a second period, period (B), of systematic and iterative use of a device for optimizing the decision to continue an anti-cancer treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically or cytologically proven non-small-cell lung carcinoma (NSCLC)including NSCLC with oncogene addiction.

  2. Stage IV or IIB/IIIC non irradiable (8th classification TNM, UICC 2015)

  3. Patient having completed at least one line of chemotherapy in the context ofmetastatic disease (or in the context of locoregional disease if the lastchemotherapy was less than 6 months ago).

  4. ECOG Performance Status ≥ 2.

  5. Age ≥ 18.

  6. Written informed consent.

  7. Patient capable, according to the investigator, to comply with the requirements ofthe study.

Exclusion

Exclusion Criteria:

  1. Small Cell Lung Cancer (including mixed forms).

  2. Patient with NSCLC for whom a decision has already been made to permanentlydiscontinue all systemic cancer treatment.

  3. Impossible follow up for geographical, social or psychological reason.

  4. Inability to answer a questionnaire (language or neurological barrier).

  5. Patient under guardianship.

  6. Patient being treated in a therapeutic trial.

  7. Patient not covered by social security. -

Study Design

Total Participants: 364
Treatment Group(s): 2
Primary Treatment: Optimization of the medical decision
Phase:
Study Start date:
September 24, 2021
Estimated Completion Date:
September 23, 2027

Study Description

We propose to study the optimization of this decision process in an advanced Non-Small-Cell Lung Carcinoma (NSCLC) population, with a Performance Status (PS) ≥ 2 (median survival of approximately 3 months) piloting iteratively (before each decision to continue treatment) a process consisting of an evaluation framework (30 items to be answered by the oncologist with the patient), consolidating:

  1. clinical parameters;

  2. doctors' expectations regarding the continuation of anticancer treatment;

  3. patient expectations and preferences;

  4. the possibility of referring the patient to a supportive care specialist and strengthening home care.

The process triggers a dialogue between the patient and the oncologist, based on facts and seeks objectivity, ultimately allowing a shared decision.

In this prospective comparative study, the rate of systemic oncological treatment during the last month of life will be measured consecutively, over a period of usual management, followed by a period of systematic application of a process of optimization of the medical decision.

Connect with a study center

  • CH Abbeville

    Abbeville, 80142
    France

    Site Not Available

  • CH Abbeville

    Abbeville 3038789, 80142
    France

    Site Not Available

  • CH du Pays d'Aix

    Aix-en-Provence, 13616
    France

    Site Not Available

  • CH du Pays d'Aix

    Aix-en-Provence 3038354, 13616
    France

    Site Not Available

  • CHU Amiens - Hôpital Sud

    Amiens, 80054
    France

    Site Not Available

  • CHU Amiens - Hôpital Sud

    Amiens 3037854, 80054
    France

    Site Not Available

  • CHU Angers

    Angers, 49933
    France

    Site Not Available

  • CHU Angers

    Angers 3037656, 49933
    France

    Site Not Available

  • CHR Metz-Thionville - Hôpital de Mercy

    Ars-Laquenexy,
    France

    Site Not Available

  • CHR Metz-Thionville - Hôpital de Mercy

    Ars-Laquenexy 3036715,
    France

    Site Not Available

  • CH Henri Duffaut Avignon

    Avignon, 84000
    France

    Active - Recruiting

  • Institut Sainte-Catherine

    Avignon, 84918
    France

    Site Not Available

  • CH Henri Duffaut Avignon

    Avignon 3035681, 84000
    France

    Site Not Available

  • Institut Sainte-Catherine

    Avignon 3035681, 84918
    France

    Site Not Available

  • AP-HP Ambroise Paré

    Boulogne-Billancourt, 92100
    France

    Site Not Available

  • AP-HP Ambroise Paré

    Boulogne-Billancourt 3031137, 92100
    France

    Site Not Available

  • CHI de Compiègne-Noyon

    Compiègne, 60200
    France

    Site Not Available

  • CHI de Compiègne-Noyon

    Compiègne 3024066, 60200
    France

    Site Not Available

  • CHU Sud Francilien

    Corbeil-Essonnes, 91100
    France

    Site Not Available

  • CHU Sud Francilien

    Corbeil-Essonnes 3023763, 91100
    France

    Site Not Available

  • Clinique des Cèdres

    Cornebarrieu, 31700
    France

    Site Not Available

  • Clinique des Cèdres

    Cornebarrieu 3023606, 31700
    France

    Site Not Available

  • CH Intercommunal de Créteil

    Créteil, 94000
    France

    Site Not Available

  • CH Intercommunal de Créteil

    Créteil 3022530, 94000
    France

    Site Not Available

  • CGFL

    Dijon, 21000
    France

    Site Not Available

  • CGFL

    Dijon 3021372, 21000
    France

    Site Not Available

  • CHU Grenoble Alpes

    Grenoble, 38043
    France

    Site Not Available

  • CHU Grenoble Alpes

    Grenoble 3014728, 38043
    France

    Site Not Available

  • CHD Vendée

    La Roche-sur-Yon, 85925
    France

    Site Not Available

  • CHD Vendée

    La Roche-sur-Yon 3006767, 85925
    France

    Site Not Available

  • CHRU Lille

    Lille, 59000
    France

    Site Not Available

  • CHRU Lille

    Lille 2998324, 59000
    France

    Site Not Available

  • Centre Léon Bérard

    Lyon, 69008
    France

    Site Not Available

  • Centre Léon Bérard

    Lyon 2996944, 69008
    France

    Site Not Available

  • HP-HM Marseille

    Marseille, 13915
    France

    Site Not Available

  • AP-HP Bichat

    Paris, 75018
    France

    Active - Recruiting

  • AP-HP Cochin

    Paris, 75014
    France

    Site Not Available

  • AP-HP Tenon

    Paris, 75970
    France

    Active - Recruiting

  • Institut Curie

    Paris, 75005
    France

    Active - Recruiting

  • AP-HP Bichat

    Paris 2988507, 75018
    France

    Site Not Available

  • AP-HP Cochin

    Paris 2988507, 75014
    France

    Site Not Available

  • AP-HP Tenon

    Paris 2988507, 75970
    France

    Site Not Available

  • Institut Curie

    Paris 2988507, 75005
    France

    Site Not Available

  • Institut Curie

    Saint-Cloud, 92210
    France

    Site Not Available

  • Institut Curie

    Saint-Cloud 2981041, 92210
    France

    Site Not Available

  • CH Saint-Malo

    Saint-Malo, 35420
    France

    Site Not Available

  • CH Saint-Malo

    St-Malo 2978640, 35420
    France

    Site Not Available

  • Hôpital Foch

    Suresnes, 92150
    France

    Site Not Available

  • Hôpital Foch

    Suresnes 2973675, 92150
    France

    Site Not Available

  • Clinique Tessier

    Valenciennes, 59300
    France

    Site Not Available

  • Clinique Tessier

    Valenciennes 2971041, 59300
    France

    Site Not Available

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