Clinical trial NCT05887011: CRT( Chemo-Radiation Therapy) Patterns and Short-term Outcomes on Unresectable NSCLC and SCLC in Routine Practices in Russia
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Unresectable /Inoperable Locally Advanced (Stage II-III) NSCLC and Locally Advanced LS-SCLC (Stage I-III)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-06-02
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include 2000 patients who received chemoradiotherapy (cCRT or sCRT) for the treatment of locally advanced NSCLC and SCLC in 50 largest oncology centers in Russian Federation. The total enrolment period will take up to 2 years. Information about specific NSCLC or SCLC treatments following CRT (e.g., durvalumab) will not be collected in the study.

Brief 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 criteria: Inclusion Criteria:

1. Age ≥ 18 years old
2. Provision of written informed consent
3. 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
4. Patient is currently undergoing RT (preferably no more than 10 doses)

Exclusion Criteria:

1. Participation in another clinical study with an investigational product during the last 3 months
2. Confirmation that the subject was already included in this study before
3. Absence of written informed consent form
4. 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.

Primary outcomes:
measure: 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.
timeFrame: Baseline
Secondary outcomes:
measure: Chemoradiotherapy (CRT) details
timeFrame: up to 6 month
measure: 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
timeFrame: up to 6 month
measure: Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC
timeFrame: up to 6 month
measure: Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC
timeFrame: up to 6 month
measure: Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC
timeFrame: up to 6 month
measure: Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC
timeFrame: up to 6 month
measure: Chemoradiotherapy (CRT) details: concurrent CRT vs sequential CRT
timeFrame: up to 6 month
measure: Chemoradiotherapy (CRT) details: presence of interruptions
timeFrame: up to 6 month
measure: Chemoradiotherapy (CRT) details: number of interruptions
timeFrame: up to 6 month
measure: Chemoradiotherapy (CRT) details: durations of interruptions
timeFrame: up to 6 month
measure: Chemoradiotherapy (CRT) details:Reasons for RT interruptions and dose reductions/ withdrawals;
timeFrame: up to 6 month
measure: Chemoradiotherapy (CRT) details:· RT: doses, fractionation, planning, selective and elective irradiation of lymph nodes
timeFrame: up to 6 month
measure: Chemoradiotherapy (CRT) details:· Type of platinum-based chemotherapy used
timeFrame: up to 6 month
measure: Chemoradiotherapy (CRT) details: For sCRT: duration between ChT and RT
timeFrame: up to 6 month
measure: Chemoradiotherapy (CRT) details
timeFrame: up to 6 month
measure: Chemoradiotherapy (CRT) details for SCLC
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Balashikha
country: Russian Federation
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Grozniy
country: Russian Federation
facility: Research Site
city: Irkutsk
country: Russian Federation
facility: Research Site
city: Ivanovo
country: Russian Federation
facility: Research Site
city: Izhevsk
country: Russian Federation
facility: Research Site
city: Kaluga
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Khabarovsk
country: Russian Federation
facility: Research Site
city: Khanty-Mansiysk
country: Russian Federation
facility: Research Site
city: Kirov
country: Russian Federation
facility: Research Site
city: Kostroma
country: Russian Federation
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Research Site
city: Novokuznetsk
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Obninsk
country: Russian Federation
facility: Research Site
city: Perm
country: Russian Federation
facility: Research Site
city: Podolsk
country: Russian Federation
facility: Research Site
city: Rostov-Na-Donu
country: Russian Federation
facility: Research Site
city: Ryazan
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saransk
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: Sochi
country: Russian Federation
facility: Research Site
city: Syktivkar
country: Russian Federation
facility: Research Site
city: Tula
country: Russian Federation
facility: Research Site
city: Tver
country: Russian Federation
facility: Research Site
city: Ulianovsk
country: Russian Federation
facility: Research Site
city: Vladivostok
country: Russian Federation
facility: Research Site
city: Vologda
country: Russian Federation
facility: Research Site
city: Yakutia
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Yuzhno-Sakhalinsk
country: Russian Federation
facility: Research Site
Study officials:
References: