Clinical trial NCT05049044: Observational Prospective Study of Quality of Life in Unresectable TNM Stage III NSCLC (OBSTINATE)
Official title: Observational Prospective Study of Quality of Life in Unresectable TNM Stage III NSCLC (OBSTINATE)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small-cell lung cancer
Unresectable
Advanced stage
Lead sponsor: Groupe Francais De Pneumo-Cancerologie
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2021-09-17
Enrollment: 413
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Every new patients diagnosed with treatment-naïve unresectable stage III non-small cell lung cancer (according to the 8th TNM IASLC edition).

Unresectability could be due to either functional limitation or anatomical extension of the tumor.

Brief 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.

Detailed description: OBSTINATE is an observational, prospective, national, multicentric study conducted in patients newly diagnosed with an unresectable stage III NSCLC (with exclusion of early stages NSCLC classified to pathological stage III).

OBSTINATE is a study planned to include 450 patients between 50 to 70 GFPC-affiliates or GFPC-associated centers approximately. All centers are located in France. The participating Site Investigators will be treating physicians within one of the participating centers.

After screening for eligibility checks, patients will receive the Patient Information Note from the Site Investigators. This Patient information Note will describe the study purpose and modalities. Patients who meet the eligibility criteria and do not oppose to data collection will be enrolled. The schedule of the medical visits in the study center will depend on the patient and his/her routine clinical care Protocol-relevant data will be collected by the treating physician within each center, for up to 5 years following the last patient's enrollment in the study.

Patients included in the study will complete the self-assess questionnaires at enrollment and during routine care follow-up, according to pre-specified data collection schedule.

Usual practices or modalities of follow-up of patients will remain unchanged compared to the current clinical practice as the study is designed to provide descriptive summary information.

Eligibility criteria: 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

Primary outcomes:
measure: QLQ-C30 (defined as the outcomes of a clinical intervention obtained by the patient)
timeFrame: Up to 6,5 years (18 months of recruitment + 5 years). For Cohort 1 & 2, a follow-up post progression is planned
measure: QLQ-LC13 (defined as the outcomes of a clinical intervention obtained by the patient)
timeFrame: Up to 6,5 years (18 months of recruitment + 5 years). For Cohort 1 & 2, a follow-up post progression is planned
measure: EQ5D-5L (defined as the outcomes of a clinical intervention obtained by the patient)
timeFrame: Up to 6,5 years (18 months of recruitment + 5 years). For Cohort 1 & 2, a follow-up post progression is planned
Secondary outcomes:
measure: Baseline demographics
timeFrame: At Baseline
measure: Tumor characteristics as defined by TNM stage
timeFrame: At Baseline
measure: Tumor characteristics as defined by PD-L1 expression status
timeFrame: At Baseline
measure: Tumor characteristics as defined by mutational status of driver genes
timeFrame: At Baseline
measure: Time from diagnosis to treatment
timeFrame: From date of diagnosis until the date of first documented treatment or start date of best supportive care through study completion, up to 5 year
measure: Modality of follow-up
timeFrame: From date of diagnosis until the date of first documented progression or or date of death from any cause, whichever came first, assessed up to 5 years maximum
measure: Median PFS
timeFrame: From date of first treatment administration up to first documented disease progression and/or death from any cause, whichever came first, assessed up to 60 months
measure: Median time to progression
timeFrame: From date of first treatment administration up to first documented disease progression and/or death from any cause, whichever came first, assessed up to 60 months
measure: Median OS (e.g. median PFS, median OS)
timeFrame: From date of first treatment administration up to first documented disease progression and/or death from any cause, whichever came first, assessed up to 60 months
measure: Treatment characteristics
timeFrame: From date of first treatment administration up to end of study, assessed up to 5 years maximum
measure: Best response of treatment
timeFrame: From date of first treatment administration up to end of study, assessed up to 5 years maximum
measure: Duration of response of treatment
timeFrame: From date of first treatment administration up to end of study, assessed up to 5 years maximum
measure: Toxicity of treatment
timeFrame: From date of first treatment administration up to end of study, assessed up to 5 years maximum
measure: Effective treatment compared to initial Multidisciplinary Tumor Board (MDTB) decision
timeFrame: From date of first treatment administration up to end of study, assessed up to 5 years maximum
measure: Type of progression (local, loco-regional, metastatic)
timeFrame: At date of first documented progression, assessed up to 5 years maximum
measure: Description of second line of treatment after disease progression
timeFrame: From date of first documented progression up to end of study, assessed up to 5 years maximum
measure: Change in patients' socio-economic and occupational outcomes using unique self questionnaire
timeFrame: From Baseline, during treatment and follow-up until confirmed progression (of note, for Cohorts 1 and 2, a follow-up post-progression is planned), loss of follow-up or end of the study, assessed up to 5 years maximum
measure: Evaluate the cost-utility of the therapeutic strategy using Quality-Adjusted Life Years (QALYs)
timeFrame: From Baseline, during treatment and follow-up until confirmed progression (of note, for Cohorts 1 and 2, a follow-up post-progression is planned), loss of follow-up or end of the study, assessed up to 5 years maximum
Other outcomes:
Locations:
city: Aix En Provence
country: France
facility: Centre Hospitalier d'Aix en Provence
city: Amiens
country: France
facility: CHU Amiens-Picardie
city: Angers
country: France
facility: Centre Hospitalier Universitaire
city: Annecy
country: France
facility: Centre Hospitalier d'Annecy
city: Antony
country: France
facility: Hôpital Privé d'Antony
city: Brest
country: France
facility: Centre Hospitalier du Morvan
city: Chambéry
country: France
facility: CHMS
city: Champigny-sur-Marne
country: France
facility: Hôpital Paul d'Egine
city: Chauny
country: France
facility: Centre Hospitalier de Chauny
city: Cherbourg
country: France
facility: Centre Hospitalier du Cotentin
city: Creteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
city: Elbeuf
country: France
facility: Centre Hospitalier d'Elbeuf - Pneumologie
city: La Roche-sur-Yon
country: France
facility: CHD Les Oudairies
city: Libourne
country: France
facility: Hôpital Robert Boulin
city: Limoges
country: France
facility: Centre Hospitalier Universitaire DUPUYTREN
city: Lorient
country: France
facility: Hôpital du Scorff
city: Lyon
country: France
facility: Centre Leon Bérard
city: Marseille
country: France
facility: Hôpital Européen
city: Marseille
country: France
facility: Hôpital Nord
city: Meaux
country: France
facility: Hôpital de Meaux
city: Orléans
country: France
facility: Centre Hospitalier Régional
city: Perpignan
country: France
facility: Centre Catalan d'Oncologie
city: Quimper
country: France
facility: Centre Hospitalier Intercommunal de Quimper
city: Rennes
country: France
facility: CHU Ponchaillou
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Saint Nazaire
country: France
facility: Clinique Mutualiste de l'Estuaire
city: Saint-Denis
country: France
facility: CHU La Réunion Site Nord
city: Saint-Pierre
country: France
facility: CHU La Réunion Site Sud
city: Saint-Priest-en-Jarez
country: France
facility: Institut Lucien Neuwirth
city: Saint-Étienne
country: France
facility: Hôpital Privé de la Loire
city: Saint-Étienne
country: France
facility: CHU Hôpital Nord
city: Tarbes
country: France
facility: CH de Bigorre Tarbes
city: Toulon
country: France
facility: Hôpital d'Instruction des Armées Ste Anne
city: Vannes
country: France
facility: CH Bretagne Atlantique
city: Villefranche Sur Saone
country: France
facility: Centre Hospitalier de Villefranche sur Saone
city: Villeneuve-Saint-Georges
country: France
facility: Centre hospitalier Intercommunal
Study officials:
affiliation: GFPC (Groupe Français de Pneumo-Cancérologie)
name: Charles RICORDEL
role: PRINCIPAL_INVESTIGATOR
affiliation: GFPC (Groupe Français de Pneumo-Cancérologie)
name: Christos CHOUAID
role: STUDY_DIRECTOR
References: