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Active, Not Recruiting

NCT Number: NCT04823377

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Abbeville, Abbeville, France

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About this study

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:

  • clinical parameters;
  • doctors' expectations regarding the continuation of anticancer treatment;
  • patient expectations and preferences;
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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. -

Treatment and study plan

Usual Care

Other

Patients receiving systemic anticancer treatment in their last days of life

Optimization of the medical decision

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Percentage of chemotherapy

    Time frame: 24 months

    Percentage of chemotherapy (IV, oral) administered in the last 60, 30 and 14 days of life,

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. Use of supportive care

    Time frame: 24 months

    Frequency and precocity of use of supportive care.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Acronym: PACT-01

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Mar 30, 2021
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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