Trial Title:
CRT( Chemo-Radiation Therapy) Patterns and Short-term Outcomes on Unresectable NSCLC in Routine Practices in Russia
NCT ID:
NCT05887011
Condition:
Unresectable /Inoperable Locally Advanced (Stage II-III) Non-small Cells Lung Cancer (NSCLC)
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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 in 50 largest oncology
centers in Russian Federation. The data for all 6000 patients with LA NSCLC 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 the
treatment results of the end of CRT will be collected. Information about any specific
NSCLC treatments following CRT (e.g., durvalumab) will not be collected in the study.
Patients with NSCLC 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.
Criteria for eligibility:
Study pop:
The study will include 6000 patients who received chemoradiotherapy (cCRT or sCRT) for
the treatment of locally advanced NSCLC in 50 largest oncology centers in Russian
Federation. The total enrolment period will take up to 2 years. Information about
specific NSCLC treatments following CRT (e.g., durvalumab) will not be collected in the
study.
Sampling method:
Non-Probability Sample
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) 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Arkhangelsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Balashikha
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Barnaul
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chelyabinsk
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Grozniy
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Irkutsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ivanovo
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Izhevsk
Country:
Russian Federation
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Kazan
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kemerovo
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Khabarovsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Khanty-Mansiysk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kirov
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kostroma
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Krasnodar
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Krasnoyarsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Moscow
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Moscow
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Nizhniy Novgorod
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Novokuznetsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Novosibirsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Obninsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Perm
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Podolsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rostov-Na-Donu
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ryazan
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Saransk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Saratov
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sochi
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Syktivkar
Country:
Russian Federation
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Tula
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tver
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ulianovsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Vladivostok
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Vologda
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Yakutia
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Yaroslavl
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Yuzhno-Sakhalinsk
Country:
Russian Federation
Status:
Recruiting
Start date:
March 31, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05887011
