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

Groupe Francais De Pneumo-Cancerologie

Status: Active, not recruiting

Conditions: Non-Small Cell Lung Cancer

Treatments: Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05049044

GFPC 06-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 413 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

413 participants in 10 patient groups

Cohort 1: cRT-CT+IO

Description:

Concomitant radio-chemotherapy and consolidation immunotherapy (cRT-CT+IO)

Treatment:

Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)

Cohort 2: sRT-CT+IO

Description:

Sequential radio-chemotherapy and consolidation immunotherapy (sRT-CT+IO)

Treatment:

Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)

Cohort 3: cRT-CT

Description:

Concomitant radio-chemotherapy (cRT-CT)

Treatment:

Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)

Cohort 4: sRT-CT

Description:

Sequential radio-chemotherapy (sRT-CT)

Treatment:

Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)

Cohort 5: CT

Description:

Chemotherapy only (CT)

Treatment:

Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)

Cohort 6: CT+IO

Description:

Chemotherapy plus immunotherapy (CT+IO)

Treatment:

Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)

Cohort 7: RT

Description:

Radiation therapy only (RT)

Treatment:

Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)

Cohort 8: IO

Description:

Immunotherapy only (IO)

Treatment:

Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)

Cohort 9: TT

Description:

Targeted therapy only (TT)

Treatment:

Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)

Cohort 10: BSC

Description:

Best supportive care only (BSC)

Treatment:

Other: Quality of Life Questionnaire-Core 30 (QLQ-C30)