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

NCT05049044 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 413

Last updated 2025-08-04

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Groupe Francais De Pneumo-Cancerologie

    lead OTHER

Principal Investigators

  • Charles RICORDEL · GFPC (Groupe Français de Pneumo-Cancérologie)

  • Christos CHOUAID · GFPC (Groupe Français de Pneumo-Cancérologie)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-18
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05049044 on ClinicalTrials.gov