NCT05049044Active, not recruiting
Observational Prospective Study of Quality of Life in Unresectable TNM Stage III NSCLC (OBSTINATE)
Source: ClinicalTrials.gov · Last updated 4 Aug 2025
Brief summary (registry, in English)
OBSTINATE is an observational, national, prospective, multicentric study on Quality of life in patients with unresecable stade III non-small cell lung cancers. Locally advanced non-small cell lung cancers (NSCLCs with a Tumor, Node and Metastasis \[TNM\] stage III) patients represent approximately a third of newly discovered NSCLCs every year, and a very heterogeneous group of clinical situations. Therapies are multidisciplinary and very heterogeneous across oncology centers. Patients with locally advanced NSCLC have a high symptom burden that is known to affect their quality of life. Health-related quality of life (HR-QoL) is a specific and multidimensional type of patient-reported outcome (PRO) related to the physical, psychological and social impact of the disease and its treatment as perceived by patients. HR-QoL allows, together with data of efficacy and safety, a more complete assessment of risks and benefits of each treatment. Therefore, QoL maintenance is a valuable consideration for treatment decisions, especially in the rapidly evolving therapeutic landscape of unresectable NSCLC. The study is designed to collect PROs HR-QoL data from every new patient diagnosed with an unresectable stage III NSCLC over a period of 18 months. We also aim to describe clinical characteristics of these patients, the therapeutic strategies conducted, and outcomes in a "real-word" oncological practice.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 413 (actual)
- First submitted
- 13 Nov 2020
- Start date
- 18 Dec 2020
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Groupe Francais De Pneumo-Cancerologie
- Diseases
- Lung cancer
- NCT number
- NCT05049044
What you commit to
- Study type: Observational
- Participants enrolled: 413
- From 18 Dec 2020 to the primary completion date, 30 Jun 2027
- 34 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Early stage NSCLC initially treated locally (surgery or other) and classified as pathological TNM stage III (according to the 8th TNM IASLC edition)
Other
- At the treating physician's discretion, patient not eligible physically or psychologically to be included in a clinical trial
- Inability to read and/or fill out self-assessment questionnaires
- Patient unable to express opposition to data collection
Who the study is looking for
- Pathological confirmation of NSCLC obtained from a tumor cytology or biopsy
- Treatment-naïve unresectable TNM stage III NSCLC (according to the 8th TNM IASLC edition). Of note, unresectability could be due to either functional limitation or anatomical extension of the tumor.
- Patient willing and able to complete collection of data via self-assessment questionnaires
- Patient without any local or systemic anti-neoplastic treatment are eligible (palliative symptomatic radiotherapy is considered best supportive care)
- Patients participating in other interventional or non-interventional studies can be included.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (34)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier d'Aix en Provence Coordinator of this site? Confirm its status | Aix-en-Provence | France | Unknown status |
| Chu Amiens Picardie Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| Centre Hospitalier Universitaire Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| Centre Hospitalier d'Annecy Coordinator of this site? Confirm its status | Annecy | France | Unknown status |
| Centre Hospitalier du Morvan Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| CHMS Coordinator of this site? Confirm its status | Chambéry | France | Unknown status |
| Hôpital Paul d'Egine Coordinator of this site? Confirm its status | Champigny-sur-Marne | France | Unknown status |
| Centre Hospitalier de Chauny Coordinator of this site? Confirm its status | Chauny | France | Unknown status |
| Centre Hospitalier du Cotentin Coordinator of this site? Confirm its status | Cherbourg | France | Unknown status |
| Centre Hospitalier Intercommunal de Créteil Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| Centre Hospitalier d'Elbeuf - Pneumologie Coordinator of this site? Confirm its status | Elbeuf | France | Unknown status |
| CHD Les Oudairies Coordinator of this site? Confirm its status | La Roche-sur-Yon | France | Unknown status |
| Hôpital Robert Boulin Coordinator of this site? Confirm its status | Libourne | France | Unknown status |
| Centre Hospitalier Universitaire DUPUYTREN Coordinator of this site? Confirm its status | Limoges | France | Unknown status |
| Hôpital du Scorff Coordinator of this site? Confirm its status | Lorient | France | Unknown status |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hopital Europeen Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Hôpital Nord Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Hôpital de Meaux Coordinator of this site? Confirm its status | Meaux | France | Unknown status |
| Centre Catalan d'Oncologie Coordinator of this site? Confirm its status | Perpignan | France | Unknown status |
| Centre Hospitalier Intercommunal de Quimper Coordinator of this site? Confirm its status | Quimper | France | Unknown status |
| CHU Ponchaillou Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| Hôpital Charles Nicolle Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| CHU La Réunion Site Nord Coordinator of this site? Confirm its status | Saint-Denis | France | Unknown status |
| Hôpital privé de la Loire Coordinator of this site? Confirm its status | Saint-Etienne | France | Unknown status |
| CHU Hôpital Nord Coordinator of this site? Confirm its status | Saint-Etienne | France | Unknown status |
| Clinique Mutualiste de l'Estuaire Coordinator of this site? Confirm its status | Saint-Nazaire | France | Unknown status |
| CHU La Réunion Site Sud Coordinator of this site? Confirm its status | Saint-Pierre | France | Unknown status |
| Institut Lucien Neuwirth Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Unknown status |
| CH de Bigorre Tarbes Coordinator of this site? Confirm its status | Tarbes | France | Unknown status |
| Hôpital d'Instruction des Armées Ste Anne Coordinator of this site? Confirm its status | Toulon | France | Unknown status |
| CH Bretagne Atlantique Coordinator of this site? Confirm its status | Vannes | France | Unknown status |
| Centre Hospitalier de Villefranche sur Saone Coordinator of this site? Confirm its status | Villefranche-sur-Saône | France | Unknown status |
| Centre hospitalier Intercommunal Coordinator of this site? Confirm its status | Villeneuve-Saint-Georges | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.