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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

Full criteria on ClinicalTrials.gov

Sites (34)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier d'Aix en Provence
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Aix-en-ProvenceFranceUnknown status
Chu Amiens Picardie
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AmiensFranceUnknown status
Centre Hospitalier Universitaire
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AngersFranceUnknown status
Centre Hospitalier d'Annecy
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AnnecyFranceUnknown status
Centre Hospitalier du Morvan
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BrestFranceUnknown status
CHMS
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ChambéryFranceUnknown status
Hôpital Paul d'Egine
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Champigny-sur-MarneFranceUnknown status
Centre Hospitalier de Chauny
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ChaunyFranceUnknown status
Centre Hospitalier du Cotentin
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CherbourgFranceUnknown status
Centre Hospitalier Intercommunal de Créteil
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CréteilFranceUnknown status
Centre Hospitalier d'Elbeuf - Pneumologie
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ElbeufFranceUnknown status
CHD Les Oudairies
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La Roche-sur-YonFranceUnknown status
Hôpital Robert Boulin
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LibourneFranceUnknown status
Centre Hospitalier Universitaire DUPUYTREN
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LimogesFranceUnknown status
Hôpital du Scorff
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LorientFranceUnknown status
Centre Leon Berard
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LyonFranceUnknown status
Hopital Europeen
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MarseilleFranceUnknown status
Hôpital Nord
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MarseilleFranceUnknown status
Hôpital de Meaux
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MeauxFranceUnknown status
Centre Catalan d'Oncologie
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PerpignanFranceUnknown status
Centre Hospitalier Intercommunal de Quimper
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QuimperFranceUnknown status
CHU Ponchaillou
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RennesFranceUnknown status
Hôpital Charles Nicolle
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RouenFranceUnknown status
CHU La Réunion Site Nord
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Saint-DenisFranceUnknown status
Hôpital privé de la Loire
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Saint-EtienneFranceUnknown status
CHU Hôpital Nord
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Saint-EtienneFranceUnknown status
Clinique Mutualiste de l'Estuaire
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Saint-NazaireFranceUnknown status
CHU La Réunion Site Sud
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Saint-PierreFranceUnknown status
Institut Lucien Neuwirth
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Saint-Priest-en-JarezFranceUnknown status
CH de Bigorre Tarbes
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TarbesFranceUnknown status
Hôpital d'Instruction des Armées Ste Anne
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ToulonFranceUnknown status
CH Bretagne Atlantique
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VannesFranceUnknown status
Centre Hospitalier de Villefranche sur Saone
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Villefranche-sur-SaôneFranceUnknown status
Centre hospitalier Intercommunal
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Villeneuve-Saint-GeorgesFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.