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

Inclusion Criteria4

  • 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)

Exclusion Criteria4

  • 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.

Locations(41)

Research Site

Arkhangelsk, Russia

Research Site

Balashikha, Russia

Research Site

Barnaul, Russia

Research Site

Chelyabinsk, Russia

Research Site

Grozny, Russia

Research Site

Irkutsk, Russia

Research Site

Ivanovo, Russia

Research Site

Izhevsk, Russia

Research Site

Kaluga, Russia

Research Site

Kazan', Russia

Research Site

Kemerovo, Russia

Research Site

Khabarovsk, Russia

Research Site

Khanty-Mansiysk, Russia

Research Site

Kirov, Russia

Research Site

Kostroma, Russia

Research Site

Krasnodar, Russia

Research Site

Krasnoyarsk, Russia

Research Site

Moscow, Russia

Research Site

Moscow, Russia

Research Site

Nizhny Novgorod, Russia

Research Site

Novokuznetsk, Russia

Research Site

Novosibirsk, Russia

Research Site

Obninsk, Russia

Research Site

Perm, Russia

Research Site

Podolsk, Russia

Research Site

Rostov-on-Don, Russia

Research Site

Ryazan, Russia

Research Site

Saint Petersburg, Russia

Research Site

Saransk, Russia

Research Site

Saratov, Russia

Research Site

Sochi, Russia

Research Site

Syktivkar, Russia

Research Site

Tula, Russia

Research Site

Tver', Russia

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Ulyanovsk, Russia

Research Site

Vladivostok, Russia

Research Site

Vologda, Russia

Research Site

Yakutia, Russia

Research Site

Yaroslavl, Russia

Research Site

Yekaterinburg, Russia

Research Site

Yuzhno-Sakhalinsk, Russia

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NCT05887011