National Multicentre Non-interventional Study to Assess CRT Patterns and Short-term Outcomes on Unresectable NSCLC and SCLC in Routine Practices in Russia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 2,000
- 试验地点
- 38
- 主要终点
- Demographic and clinical characteristics of the population. NSCLC stage by TNM classification (% of patients). Patient status - locoregional recurrence and inoperable. Histology type. % of patients with known PD-L1 status and EGFR mutation status.
研究概览
简要总结
This is a multi-center, non-interventional, study with the aim to access routine practice of diagnostic and treatment approaches in patients with NSCLC and SCLC in 50 largest oncology centers in Russian Federation. The data for all 2000 patients with LA NSCLC and LS-SCLC who receiving CRT will have been collected for 2 years from the primary medical records. Demographic and clinical characteristics of the patients, information of routine diagnostics procedures and treatment approaches for patients with unresectable LA NSCLC and LS-SCLC and the treatment results of the end of CRT will be collected. Information about any specific NSCLC or SCLC treatments following CRT (e.g., durvalumab) will not be collected in the study. Patients with NSCLC and SCLC meeting the inclusion criteria will be prospectively enrolled into the study. Study procedures will comply with all the local regulatory requirements regarding AE reporting (pharmacovigilance). Study design considers secondary data collection approach using existing patients' medical records, after patients' visits according to routine sites' practice. Data for visit (record) 1 will be collected at the start of CRT (concurrent or sequential), and data for visit (record) 2 will be collected after the last dose of RT and with CT control results available, but the time frame for this data collection is expected to be no later than 6 months after visit 1.
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
- •Age ≥ 18 years old
- •Provision of written informed consent
- •Patient received at least one RT dose under prescribed CRT (concurrent or sequential) for definitive treatment of locally advanced NSCLC (stage II-III, unresectable or inoperable NSCLC, including locoregional recurrence and patient's refusal to undergo surgery) or LS-SCLC based on local MDT decision
- •Patient is currently undergoing RT (preferably no more than 10 doses)
排除标准
- •Participation in another clinical study with an investigational product during the last 3 months
- •Confirmation that the subject was already included in this study before
- •Absence of written informed consent form
- •Data erroneously collected from subjects for which written consent is not available, will not be included in or will be deleted from the study database.
研究组 & 干预措施
LA NSCLC
unresectable/inoperable (stage II-III) locally advanced Non-Small Cell Lung Cancer
LS-SCLC
unresectable/inoperable Limited-stage small cell lung carcinoma (stage I-III)
结局指标
主要结局
Demographic and clinical characteristics of the population. NSCLC stage by TNM classification (% of patients). Patient status - locoregional recurrence and inoperable. Histology type. % of patients with known PD-L1 status and EGFR mutation status.
时间窗: Baseline
* % of patients with each TNM stage * % of patient with locoregional recurrence and inoperable patients (including patient's refusal) * Median age at the start of CRTs, % male/female, % of patients with comorbidities (and % by comorbidity type by MedDRA SOC/PT), % on concomitant medications, * % of patients by ECOG category; * % of patients with each tumour histology type; * % of patients with known PD-L1 status (and of those - % positive); * % of patients with known EGFR mutation status (and of those % by mutation status). * of patients with SCLC from all patients with locally or locally advanced LC receiving CRT * of patients with each TNM stage among SCLC * of pts with locoregional recurrence and inoperable pts among SCLC (including pt's refusal Median age at the start of CRTs, % male/female, % of patients with comorbidities (and % by comorbidity type by MedDRA SOC/PT), % on concomitant medications among SCLC * of patients by ECOG category among SCLC
次要结局
- Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC(up to 6 month)
- Chemoradiotherapy (CRT) details(up to 6 month)
- The short-term effectiveness results of the initial CRT treatment administered to patients with recently first diagnosed LA NSCLC or LS-SCLC (% of patients with CR, PR, ORR, SD, PD, unevaluable for response) for cCRT and sCRT respectively(up to 6 month)
- Chemoradiotherapy (CRT) details: concurrent CRT vs sequential CRT(up to 6 month)
- Chemoradiotherapy (CRT) details: presence of interruptions(up to 6 month)
- Chemoradiotherapy (CRT) details: number of interruptions(up to 6 month)
- Chemoradiotherapy (CRT) details: durations of interruptions(up to 6 month)
- Chemoradiotherapy (CRT) details:Reasons for RT interruptions and dose reductions/ withdrawals;(up to 6 month)
- Chemoradiotherapy (CRT) details:· RT: doses, fractionation, planning, selective and elective irradiation of lymph nodes(up to 6 month)
- Chemoradiotherapy (CRT) details:· Type of platinum-based chemotherapy used(up to 6 month)
- Chemoradiotherapy (CRT) details: For sCRT: duration between ChT and RT(up to 6 month)
- Chemoradiotherapy (CRT) details for SCLC(Up to 6 months)