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ACTIVE NOT RECRUITING
NCT05049044

Observational Prospective Study of Quality of Life in Unresectable TNM Stage III NSCLC (OBSTINATE)

Sponsor: Groupe Francais De Pneumo-Cancerologie

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

413

Start Date

2020-12-18

Completion Date

2027-06-30

Last Updated

2025-08-04

Healthy Volunteers

No

Interventions

OTHER

Quality of Life Questionnaire-Core 30 (QLQ-C30)

The HR-QoL evaluation is based on three self-assessment questionnaires distributed to the patients according to the pre-specified data collection schedule. Patients will also complete an additional questionnaire on socio-economic and occupational outcomes

Locations (34)

Centre Hospitalier d'Aix en Provence

Aix-en-Provence, France

CHU Amiens-Picardie

Amiens, France

Centre Hospitalier Universitaire

Angers, France

Centre Hospitalier d'Annecy

Annecy, France

Centre Hospitalier du Morvan

Brest, France

CHMS

Chambéry, France

Hôpital Paul d'Egine

Champigny-sur-Marne, France

Centre Hospitalier de Chauny

Chauny, France

Centre Hospitalier du Cotentin

Cherbourg, France

Centre Hospitalier Intercommunal de Créteil

Créteil, France

Centre Hospitalier d'Elbeuf - Pneumologie

Elbeuf, France

CHD Les Oudairies

La Roche-sur-Yon, France

Hôpital Robert Boulin

Libourne, France

Centre Hospitalier Universitaire DUPUYTREN

Limoges, France

Hôpital du Scorff

Lorient, France

Centre Leon Bérard

Lyon, France

Hôpital Européen

Marseille, France

Hôpital Nord

Marseille, France

Hôpital de Meaux

Meaux, France

Centre Catalan d'Oncologie

Perpignan, France

Centre Hospitalier Intercommunal de Quimper

Quimper, France

CHU Ponchaillou

Rennes, France

Hôpital Charles Nicolle

Rouen, France

CHU La Réunion Site Nord

Saint-Denis, France

Hôpital Privé de la Loire

Saint-Etienne, France

CHU Hôpital Nord

Saint-Etienne, France

Clinique Mutualiste de l'Estuaire

Saint-Nazaire, France

CHU La Réunion Site Sud

Saint-Pierre, France

Institut Lucien Neuwirth

Saint-Priest-en-Jarez, France

CH de Bigorre Tarbes

Tarbes, France

Hôpital d'Instruction des Armées Ste Anne

Toulon, France

CH Bretagne Atlantique

Vannes, France

Centre Hospitalier de Villefranche sur Saone

Villefranche-sur-Saône, France

Centre hospitalier Intercommunal

Villeneuve-Saint-Georges, France