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

Non-Small Cell Lung Cancer Clinical Trial

— OBSTINATE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05049044
• Other study ID #: GFPC 06-2019
• Status: Active, not recruiting
• Start date: December 18, 2020
• Est. completion date: June 30, 2027

Study information

• Verified date: October 2023
• Source: Groupe Francais De Pneumo-Cancerologie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 413
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

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

Country	Name	City	State
France	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	Hôpital Privé d'Antony	Antony
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	Creteil
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 Hospitalier Régional	Orléans
France	Centre Catalan d'Oncologie	Perpignan
France	Centre Hospitalier Intercommunal de Quimper	Quimper
France	CHU Ponchaillou	Rennes
France	Hôpital Charles Nicolle	Rouen
France	Clinique Mutualiste de l'Estuaire	Saint Nazaire
France	CHU La Réunion Site Nord	Saint-Denis
France	CHU Hôpital Nord	Saint-Étienne
France	Hôpital Privé de la Loire	Saint-Étienne
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 Saone
France	Centre hospitalier Intercommunal	Villeneuve-Saint-Georges

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Francais De Pneumo-Cancerologie	AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QLQ-C30 (defined as the outcomes of a clinical intervention obtained by the patient)	Change in patient's QLQ-C30 during treatment and follow-up until confirmed progression, loss of follow-up or end of the study compared to Baseline in patients diagnosed with unresectable stage III NSCLC in a "real-world" oncological practice.; This evaluation is based on self-assess questionnaire distributed to the patients according to pre-specified data collection schedule.; The primary objective will be addressed in the cohort as a whole, and independently for every cohort of interest.	Up to 6,5 years (18 months of recruitment + 5 years). For Cohort 1 & 2, a follow-up post progression is planned
Primary	QLQ-LC13 (defined as the outcomes of a clinical intervention obtained by the patient)	Change in patient's QLQ-LC13 during treatment and follow-up until confirmed progression, loss of follow-up or end of the study compared to Baseline in patients diagnosed with unresectable stage III NSCLC in a "real-world" oncological practice.; This evaluation is based on self-assess questionnaire distributed to the patients according to pre-specified data collection schedule.; The primary objective will be addressed in the cohort as a whole, and independently for every cohort of interest.	Up to 6,5 years (18 months of recruitment + 5 years). For Cohort 1 & 2, a follow-up post progression is planned
Primary	EQ5D-5L (defined as the outcomes of a clinical intervention obtained by the patient)	Change in patient's EQ5D-5L during treatment and follow-up until confirmed progression, loss of follow-up or end of the study compared to Baseline in patients diagnosed with unresectable stage III NSCLC in a "real-world" oncological practice.; This evaluation is based on self-assess questionnaire distributed to the patients according to pre-specified data collection schedule.; The primary objective will be addressed in the cohort as a whole, and independently for every cohort of interest.	Up to 6,5 years (18 months of recruitment + 5 years). For Cohort 1 & 2, a follow-up post progression is planned
Secondary	Baseline demographics	Stage III unresectable NSCLC patients characteristics: baseline patient demographics at stage III NSCLC diagnosis, clinical, pathological and molecular characteristics (e.g. age, race, comorbidities)	At Baseline
Secondary	Tumor characteristics as defined by TNM stage	Characterize the stage III unresectable NSCLC patients by TNM stage according to the 8th TNM IASLC edition	At Baseline
Secondary	Tumor characteristics as defined by PD-L1 expression status	Characterize the stage III unresectable NSCLC patients by PD-L1 expression status (tumor propensity score)	At Baseline
Secondary	Tumor characteristics as defined by mutational status of driver genes	Characterize the stage III unresectable NSCLC patients by mutational status of driver genes (e.g. epidermal growth factor receptor [EGFR]) anaplastic lymphoma kinase [ALK], reactive oxygen species 1 [ROS1], human epidermal growth factor receptor 2 [HER2], PI3KCA, BRAF, MET, rearranged during transfection [RET], neurotrophic receptor tyrosine kinase [NRTK])	At Baseline
Secondary	Time from diagnosis to treatment		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
Secondary	Modality of follow-up	Description of modality of follow-up (e.g. type of imagery used, frequency of medical visit)	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
Secondary	Median PFS	Time from date of first treatment administration until the date of first documented progression or date to death from any cause, whichever came first as evaluated by investigators.	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
Secondary	Median time to progression	Time from date of first treatment administration until the date of first documented progression or date to death from any cause, whichever came first as evaluated by investigators.	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
Secondary	Median OS (e.g. median PFS, median OS)	Time from date of first treatment administration until the date of first documented progression or date to death from any cause, whichever came first as evaluated by investigators.	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
Secondary	Treatment characteristics	Describe the chemotherapy, radiation therapy and immunotherapy protocols used (e.g. dose, reduction, interruptions, duration)	From date of first treatment administration up to end of study, assessed up to 5 years maximum
Secondary	Best response of treatment		From date of first treatment administration up to end of study, assessed up to 5 years maximum
Secondary	Duration of response of treatment		From date of first treatment administration up to end of study, assessed up to 5 years maximum
Secondary	Toxicity of treatment	limited to Cohorts 1, 2, 3 and 4 (restricted to significant AEs, which include but are not limited to: serious AEs [SAEs], AEs that led to treatment discontinuation, or any AEs = grade 3 judged clinically significant by the Site Investigator)	From date of first treatment administration up to end of study, assessed up to 5 years maximum
Secondary	Effective treatment compared to initial Multidisciplinary Tumor Board (MDTB) decision	Concordance between effective treatment compared to initial MDTB decision	From date of first treatment administration up to end of study, assessed up to 5 years maximum
Secondary	Type of progression (local, loco-regional, metastatic)		At date of first documented progression, assessed up to 5 years maximum
Secondary	Description of second line of treatment after disease progression	Treatment characteristics after disease progression including type of treatment (chemotherapy, radiotherapy, immunotherapy or Tyrosine-Kinase inhibitors), treatment duration, stop date of treatment and reason for end of treatment	From date of first documented progression up to end of study, assessed up to 5 years maximum
Secondary	Change in patients' socio-economic and occupational outcomes using unique self questionnaire	Change in patients' socio-economic and occupational outcomes 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 using a dedicated self questionnaire on socio-economic and occupational outcomes	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
Secondary	Evaluate the cost-utility of the therapeutic strategy using Quality-Adjusted Life Years (QALYs)		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