Observational Prospective Study of Quality of Life in Unresectable TNM Stage III NSCLC (OBSTINATE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 413
- 试验地点
- 34
- 主要终点
- QLQ-LC13 (defined as the outcomes of a clinical intervention obtained by the patient)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
QLQ-LC13 (defined as the outcomes of a clinical intervention obtained by the patient)
时间窗: Up to 6,5 years (18 months of recruitment + 5 years). For Cohort 1 & 2, a follow-up post progression is planned
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.
EQ5D-5L (defined as the outcomes of a clinical intervention obtained by the patient)
时间窗: Up to 6,5 years (18 months of recruitment + 5 years). For Cohort 1 & 2, a follow-up post progression is planned
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.
QLQ-C30 (defined as the outcomes of a clinical intervention obtained by the patient)
时间窗: Up to 6,5 years (18 months of recruitment + 5 years). For Cohort 1 & 2, a follow-up post progression is planned
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.
次要结局
- Tumor characteristics as defined by mutational status of driver genes(At Baseline)
- Median OS (e.g. median PFS, median OS)(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)
- Tumor characteristics as defined by PD-L1 expression status(At Baseline)
- 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)
- Modality of follow-up(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)
- Duration of response of treatment(From date of first treatment administration up to end of study, assessed up to 5 years maximum)
- Toxicity of treatment(From date of first treatment administration up to end of study, assessed up to 5 years maximum)
- Baseline demographics(At Baseline)
- Tumor characteristics as defined by TNM stage(At Baseline)
- Treatment characteristics(From date of first treatment administration up to end of study, assessed up to 5 years maximum)
- Effective treatment compared to initial Multidisciplinary Tumor Board (MDTB) decision(From date of first treatment administration up to end of study, assessed up to 5 years maximum)
- Type of progression (local, loco-regional, metastatic)(At date of first documented progression, assessed up to 5 years maximum)
- Median PFS(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)
- Best response of treatment(From date of first treatment administration up to end of study, assessed up to 5 years maximum)
- Description of second line of treatment after disease progression(From date of first documented progression up to end of study, assessed up to 5 years maximum)
- Change in patients' socio-economic and occupational outcomes using unique self questionnaire(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)
- Median time to progression(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)
- 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)