RecruitingNCT05887011

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

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


Sponsor

AstraZeneca

Enrollment

2,000 participants

Start Date

Mar 31, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study is collecting real-world data on how lung cancer patients in Russia are treated with combined chemotherapy and radiation therapy (CRT), and what their short-term outcomes look like after this treatment. **You may be eligible if...** - You are 18 years old or older - You have locally advanced non-small cell lung cancer (NSCLC, stage II–III) or limited-stage small cell lung cancer (LS-SCLC) - You are currently receiving combined chemotherapy and radiation therapy as your main treatment - You are early in your radiation treatment course (ideally no more than 10 doses received) **You may NOT be eligible if...** - You have participated in another clinical trial with an investigational drug in the last 3 months - You have already been enrolled in this same study - You are unable to give written consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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NCT05887011