Optimizing decisions on cancer treatment for patients with advanced lung cancer
Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
This study is testing a new tool to help doctors and patients with advanced lung cancer make better decisions about whether to continue or stop treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 364 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Curie Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 25 sites (Abbeville and 24 other locations) |
| Trial ID | NCT04823377 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of an optimization device designed to assist oncologists and patients in making informed decisions about continuing or stopping cancer treatments for advanced Non-Small-Cell Lung Carcinoma (NSCLC). It involves a sequential comparative approach, where one group receives usual care while another group uses the optimization device to guide discussions about treatment options. The device incorporates clinical parameters, doctor and patient expectations, and the possibility of supportive care, aiming to enhance shared decision-making. The study will measure the rate of systemic oncological treatment during the last month of life across both groups.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced NSCLC who have a Performance Status of 2 or higher and have undergone at least one line of chemotherapy.
Not a fit: Patients with Small Cell Lung Cancer or those who have already decided to discontinue all systemic cancer treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and appropriate end-of-life care for patients with advanced lung cancer.
How similar studies have performed: While this approach is innovative, similar studies focusing on decision-making optimization in cancer care have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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. -
Where this trial is running
Abbeville and 24 other locations
- CH Abbeville — Abbeville, France (Recruiting)
- CH du Pays d'Aix — Aix-en-Provence, France (Recruiting)
- CHU Amiens - Hôpital Sud — Amiens, France (Recruiting)
- CHU Angers — Angers, France (Recruiting)
- CHR Metz-Thionville - Hôpital de Mercy — Ars-Laquenexy, France (Recruiting)
- CH Henri Duffaut Avignon — Avignon, France (Recruiting)
- Institut Sainte-Catherine — Avignon, France (Recruiting)
- AP-HP Ambroise Paré — Boulogne-Billancourt, France (Recruiting)
- CHI de Compiègne-Noyon — Compiègne, France (Recruiting)
- CHU Sud Francilien — Corbeil-Essonnes, France (Recruiting)
- Clinique des Cèdres — Cornebarrieu, France (Recruiting)
- CH Intercommunal de Créteil — Créteil, France (Recruiting)
- Cgfl — Dijon, France (Not_yet_recruiting)
- CHU Grenoble Alpes — Grenoble, France (Recruiting)
- CHD Vendée — La Roche-sur-Yon, France (Recruiting)
- CHRU Lille — Lille, France (Recruiting)
- Centre Léon Bérard — Lyon, France (Recruiting)
- Institut Curie — Paris, France (Recruiting)
- AP-HP Cochin — Paris, France (Recruiting)
- AP-HP Bichat — Paris, France (Recruiting)
- AP-HP Tenon — Paris, France (Recruiting)
- Institut Curie — Saint-Cloud, France (Recruiting)
- CH Saint-Malo — Saint-Malo, France (Recruiting)
- Hôpital Foch — Suresnes, France (Recruiting)
- Clinique Tessier — Valenciennes, France (Recruiting)
Study contacts
- Principal investigator: Marie-Ange MASSIANI, MD — Institut Curie
- Study coordinator: Marie-Ange MASSIANI, MD
- Email: marieange.massiani@curie.fr
- Phone: +33 1 47 11 15 15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.