Clinical trial · Observational
Observational Prospective Study of Quality of Life in Unresectable TNM Stage III NSCLC (OBSTINATE)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quality of Life Questionnaire-Core 30 (QLQ-C30) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (10)
- label
- Cohort 1: cRT-CT+IO
- description
- Concomitant radio-chemotherapy and consolidation immunotherapy (cRT-CT+IO)
- interventionNames
- Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)
- label
- Cohort 2: sRT-CT+IO
- description
- Sequential radio-chemotherapy and consolidation immunotherapy (sRT-CT+IO)
- interventionNames
- Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)
- label
- Cohort 3: cRT-CT
- description
- Concomitant radio-chemotherapy (cRT-CT)
- interventionNames
- Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Early stage NSCLC initially treated locally (surgery or other) and classified as pathological TNM stage III (according to the 8th TNM IASLC edition) * 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
References
Publications (0)
Data not yet available