Study identifier:D133HR00026
ClinicalTrials.gov identifier:NCT05887011
EudraCT identifier:N/A
CTIS identifier:N/A
National multicentre non-interventional study to assess CRT patterns and short-term outcomes on unresectable NSCLC and SCLC in routine practices in Russia
unresectable /inoperable locally advanced (stage II-III) NSCLC and locally advanced LS-SCLC (stage I-III)
N/A
No
-
All
2000
Observational
18 Years - n/a
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
-
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.
Location
Status
Location
Yaroslavl, Russian Federation
Status
Recruiting
Location
Obninsk, Russian Federation
Status
Recruiting
Location
Krasnoyarsk, Russian Federation
Status
Recruiting
Location
Moscow, Russian Federation
Status
Recruiting
Location
Khabarovsk, Russian Federation
Status
Recruiting
Location
Nizhniy Novgorod, Russian Federation
Status
Recruiting
Location
Kemerovo, Russian Federation
Status
Recruiting
Location
Chelyabinsk, Russian Federation
Status
Withdrawn
Arms | Assigned Interventions |
---|---|
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) | - |
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