NCT04823377

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
364

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

25 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Sep 2021Sep 2027

First Submitted

Initial submission to the registry

March 29, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

September 24, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2027

Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

5 years

First QC Date

March 29, 2021

Last Update Submit

November 26, 2025

Conditions

Carcinoma, Non-Small-Cell LungAdvanced Cancer

Keywords

cancer therapylast days of lifeoptimization device

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients receiving systemic anticancer treatment in their last days of life

    Comparison of the percentage of patients receiving systemic anticancer treatment in their last 30 days of life during each period

    24 months

Secondary Outcomes (8)

  • Percentage of chemotherapy

    24 months

  • Number of emergency room visits

    24 months

  • Percentage of initiation of a new line of chemotherapy

    24 months

  • Percentage of immunotherapy and of Tyrosine kinase inhibitor

    24 months

  • Percentage of initiation of Tyrosine kinase inhibitor or immunotherapy

    24 months

  • +3 more secondary outcomes

Study Arms (2)

Period A: Usual management

OTHER

Period of end-of-life care as usual

Other: Usual care

Period B: Process of optimization of the medical decision

OTHER

Period of systematic and iterative use of a device for optimizing the decision to continue an anti-cancer treatment.

Other: Optimization of the medical decision

Interventions

Usual careOTHER

Patients receiving systemic anticancer treatment in their last days of life

Period A: Usual management
Optimization of the medical decisionOTHER

Impact of the use of an optimization device of the decision of cancer treatment on aggressiveness of end of life care

Period B: Process of optimization of the medical decision

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically proven non-small-cell lung carcinoma (NSCLC) including NSCLC with oncogene addiction.
  • Stage IV or IIB/IIIC non irradiable (8th classification TNM, UICC 2015)
  • Patient having completed at least one line of chemotherapy in the context of metastatic disease (or in the context of locoregional disease if the last chemotherapy was less than 6 months ago).
  • ECOG Performance Status ≥ 2.
  • Age ≥ 18.
  • Written informed consent.
  • Patient capable, according to the investigator, to comply with the requirements of the study.

You may not qualify if:

  • Small Cell Lung Cancer (including mixed forms).
  • Patient with NSCLC for whom a decision has already been made to permanently discontinue all systemic cancer treatment.
  • Impossible follow up for geographical, social or psychological reason.
  • Inability to answer a questionnaire (language or neurological barrier).
  • Patient under guardianship.
  • Patient being treated in a therapeutic trial.
  • Patient not covered by social security. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

CH Abbeville

Abbeville, 80142, France

Location

CH du Pays d'Aix

Aix-en-Provence, 13616, France

Location

CHU Amiens - Hôpital Sud

Amiens, 80054, France

Location

CHU Angers

Angers, 49933, France

Location

CHR Metz-Thionville - Hôpital de Mercy

Ars-Laquenexy, France

Location

CH Henri Duffaut Avignon

Avignon, 84000, France

Location

Institut Sainte-Catherine

Avignon, 84918, France

Location

AP-HP Ambroise Paré

Boulogne-Billancourt, 92100, France

Location

CHI de Compiègne-Noyon

Compiègne, 60200, France

Location

CHU Sud Francilien

Corbeil-Essonnes, 91100, France

Location

Clinique des Cèdres

Cornebarrieu, 31700, France

Location

CH Intercommunal de Créteil

Créteil, 94000, France

Location

CGFL

Dijon, 21000, France

Location

CHU Grenoble Alpes

Grenoble, 38043, France

Location

CHD Vendée

La Roche-sur-Yon, 85925, France

Location

CHRU Lille

Lille, 59000, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Institut Curie

Paris, 75005, France

Location

AP-HP Cochin

Paris, 75014, France

Location

AP-HP Bichat

Paris, 75018, France

Location

AP-HP Tenon

Paris, 75970, France

Location

Institut Curie

Saint-Cloud, 92210, France

Location

CH Saint-Malo

St-Malo, 35420, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

Clinique Tessier

Valenciennes, 59300, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Marie-Ange MASSIANI, MD

    Institut Curie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2021

First Posted

March 30, 2021

Study Start

September 24, 2021

Primary Completion (Estimated)

September 23, 2026

Study Completion (Estimated)

September 23, 2027

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Sponsor will share de-identified data sets Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access Criteria
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR(25)