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RECRUITING
NCT05887011

CRT( Chemo-Radiation Therapy) Patterns and Short-term Outcomes on Unresectable NSCLC and SCLC in Routine Practices in Russia

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

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.

Official title: National Multicentre Non-interventional Study to Assess CRT Patterns and Short-term Outcomes on Unresectable NSCLC and SCLC in Routine Practices in Russia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2000

Start Date

2023-03-31

Completion Date

2026-06-30

Last Updated

2026-01-21

Healthy Volunteers

No

Locations (41)

Research Site

Arkhangelsk, Russia

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Balashikha, Russia

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Barnaul, Russia

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Chelyabinsk, Russia

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Grozny, Russia

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Irkutsk, Russia

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Ivanovo, Russia

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Izhevsk, Russia

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Kaluga, Russia

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Kazan', Russia

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Kemerovo, Russia

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Khabarovsk, Russia

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Khanty-Mansiysk, Russia

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Kirov, Russia

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Kostroma, Russia

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Krasnodar, Russia

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Krasnoyarsk, Russia

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Moscow, Russia

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Moscow, Russia

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Nizhny Novgorod, Russia

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Novokuznetsk, Russia

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Novosibirsk, Russia

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Obninsk, Russia

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Perm, Russia

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Podolsk, Russia

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Rostov-on-Don, Russia

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Ryazan, Russia

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Saint Petersburg, Russia

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Saransk, Russia

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Saratov, Russia

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Sochi, Russia

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Syktivkar, Russia

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Tula, Russia

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Tver', Russia

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Ulyanovsk, Russia

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Vladivostok, Russia

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Vologda, Russia

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Yakutia, Russia

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Yaroslavl, Russia

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Yekaterinburg, Russia

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Yuzhno-Sakhalinsk, Russia