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.
Study Type
OBSERVATIONAL
Enrollment
2,000
Research Site
Arkhangelsk, Russia
RECRUITINGResearch Site
Balashikha, Russia
RECRUITINGResearch Site
Barnaul, Russia
RECRUITINGResearch Site
Chelyabinsk, Russia
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.
* % 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
Time frame: Baseline
Chemoradiotherapy (CRT) details
· % of induction chemotherapy,
Time frame: 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
* % of patients with CR, * % of patients with PR, * % of patients with OR (ORR), * % of patients with SD, * % of patients with PD, * % of patients unevaluable for response
Time frame: up to 6 month
Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC
Frequency distribution of each diagnostic approach applied;
Time frame: up to 6 month
Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC
Median time between the date patient first came to oncology center and the date of examination (by each approach);
Time frame: up to 6 month
Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC
Median time between the date of examination and date of start of CRT (by each approach);
Time frame: up to 6 month
Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC
Frequency distribution of results by categories (for example, staging, size, location, etc.) for each approach.
Time frame: up to 6 month
Chemoradiotherapy (CRT) details: concurrent CRT vs sequential CRT
Frequency distribution of patients who receive concurrent or sequential CRT
Time frame: up to 6 month
Chemoradiotherapy (CRT) details: presence of interruptions
% of CRT interruptions
Time frame: up to 6 month
Chemoradiotherapy (CRT) details: number of interruptions
average number of interruptions per patients
Time frame: up to 6 month
Chemoradiotherapy (CRT) details: durations of interruptions
median interruption duration (days) (based on mean duration per patient)
Time frame: up to 6 month
Chemoradiotherapy (CRT) details:Reasons for RT interruptions and dose reductions/ withdrawals;
frequency distribution of reasons to interrupt or stop RT
Time frame: up to 6 month
Chemoradiotherapy (CRT) details:· RT: doses, fractionation, planning, selective and elective irradiation of lymph nodes
frequency distribution of the number of RT fractions received
Time frame: up to 6 month
Chemoradiotherapy (CRT) details:· Type of platinum-based chemotherapy used
Frequency distribution of number chemotherapy courses, of types of platinum chemotherapy used
Time frame: up to 6 month
Chemoradiotherapy (CRT) details: For sCRT: duration between ChT and RT
For sCRT: range and median number of chemotherapy courses, median days between chemotherapy and radiotherapy
Time frame: up to 6 month
Chemoradiotherapy (CRT) details
· For ChT: number of chemotherapy courses
Time frame: up to 6 month
Chemoradiotherapy (CRT) details for SCLC
Frequency distribution of the number of RT and doses received per day (2x1,5 Gy or 1X2 or 3 Gy)
Time frame: Up to 6 months
AstraZeneca Clinical Study Information Center
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Research Site
Grozny, Russia
RECRUITINGResearch Site
Irkutsk, Russia
RECRUITINGResearch Site
Ivanovo, Russia
RECRUITINGResearch Site
Izhevsk, Russia
WITHDRAWNResearch Site
Kaluga, Russia
RECRUITINGResearch Site
Kazan', Russia
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