Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer. (PACT-01)

November 26, 2025 updated by: Institut Curie
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
364

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Abbeville, France, 80142
        • CH Abbeville
      • Aix-en-Provence, France, 13616
        • CH du Pays D'Aix
      • Amiens, France, 80054
        • CHU Amiens - Hopital Sud
      • Angers, France, 49933
        • CHU Angers
      • Ars-Laquenexy, France
        • Chr Metz-Thionville - Hopital de Mercy
      • Avignon, France, 84918
        • Institut Sainte-Catherine
      • Avignon, France, 84000
        • CH Henri Duffaut Avignon
      • Boulogne-Billancourt, France, 92100
        • AP-HP Ambroise Paré
      • Compiègne, France, 60200
        • CHI de Compiègne-Noyon
      • Corbeil-Essonnes, France, 91100
        • CHU Sud Francilien
      • Cornebarrieu, France, 31700
        • Clinique des Cèdres
      • Créteil, France, 94000
        • Ch Intercommunal de Creteil
      • Dijon, France, 21000
        • CGFL
      • Grenoble, France, 38043
        • Chu Grenoble Alpes
      • La Roche-sur-Yon, France, 85925
        • CHD Vendée
      • Lille, France, 59000
        • Chru Lille
      • Lyon, France, 69008
        • Centre Léon Bérard
      • Paris, France, 75005
        • Institut Curie
      • Paris, France, 75014
        • Ap-Hp Cochin
      • Paris, France, 75018
        • AP-HP Bichat
      • Paris, France, 75970
        • AP-HP Tenon
      • Saint-Cloud, France, 92210
        • Institut Curie
      • St-Malo, France, 35420
        • CH Saint-Malo
      • Suresnes, France, 92150
        • Hopital Foch
      • Valenciennes, France, 59300
        • Clinique Tessier

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 of metastatic disease (or in the context of locoregional disease if the last chemotherapy 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 of the study.

Exclusion Criteria:

  1. Small Cell Lung Cancer (including mixed forms).
  2. Patient with NSCLC for whom a decision has already been made to permanently discontinue 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 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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Period A: Usual management
Period of end-of-life care as usual
Other: Usual care
Patients receiving systemic anticancer treatment in their last days of life
Other: Period B: Process of optimization of the medical decision
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
Impact of the use of an optimization device of the decision of cancer treatment on aggressiveness of end of life care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of patients receiving systemic anticancer treatment in their last days of life
Time Frame: 24 months
Comparison of the percentage of patients receiving systemic anticancer treatment in their last 30 days of life during each period
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of chemotherapy
Time Frame: 24 months
Percentage of chemotherapy (IV, oral) administered in the last 60, 30 and 14 days of life,
24 months
Number of emergency room visits
Time Frame: 24 months
Percentage of patients visiting emergency room visits more than once and of unplanned hospitalizations and intensive care admission in the last month of life.
24 months
Percentage of initiation of a new line of chemotherapy
Time Frame: 24 months
Percentage of initiation of a new line of chemotherapy (IV, oral) in the last month of life
24 months
Percentage of immunotherapy and of Tyrosine kinase inhibitor
Time Frame: 24 months
Percentage of immunotherapy and of Tyrosine kinase inhibitor in the last 60, 30 and 14 days of life.
24 months
Percentage of initiation of Tyrosine kinase inhibitor or immunotherapy
Time Frame: 24 months
Percentage of initiation of Tyrosine kinase inhibitor or immunotherapy in the last month of life.
24 months
Use of supportive care
Time Frame: 24 months
Frequency and precocity of use of supportive care.
24 months
Overall survival (OS)
Time Frame: 24 months
Overall survival (OS) defined as the time from the date of consent to the date of death due to any cause.
24 months
Quality of life using QLQ-C15-PAL EORTC (European Organization for Research and Treatment of Cancer) and anxiety with HAD (Hospital Anxiety and Depression) questionnaire
Time Frame: 24 months
The quality of Life in palliative cancer care patients will be collected with QLQ-C15-PAL EORTC scale and anxiety will be mesured with HAD scale.
24 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Curie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marie-Ange MASSIANI, MD, Institut Curie

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 24, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 23, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IC 2020-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.

IPD Sharing 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).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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