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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LA NSCLC | unresectable/inoperable (stage II-III) locally advanced Non-Small Cell Lung Cancer | ||
| LS-SCLC | unresectable/inoperable Limited-stage small cell lung carcinoma (stage I-III) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Chemoradiotherapy (CRT) details | · % of induction chemotherapy, | up to 6 month |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Arkhangelsk | Russia | ||||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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|
| up to 6 month |
| Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC | Frequency distribution of each diagnostic approach applied; | up to 6 month |
| Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC | Median time between the date patient first came to oncology center and the date of examination (by each approach); | up to 6 month |
| Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC | Median time between the date of examination and date of start of CRT (by each approach); | up to 6 month |
| Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC | Frequency distribution of results by categories (for example, staging, size, location, etc.) for each approach. | up to 6 month |
| Chemoradiotherapy (CRT) details: concurrent CRT vs sequential CRT | Frequency distribution of patients who receive concurrent or sequential CRT | up to 6 month |
| Chemoradiotherapy (CRT) details: presence of interruptions | % of CRT interruptions | up to 6 month |
| Chemoradiotherapy (CRT) details: number of interruptions | average number of interruptions per patients | up to 6 month |
| Chemoradiotherapy (CRT) details: durations of interruptions | median interruption duration (days) (based on mean duration per patient) | up to 6 month |
| Chemoradiotherapy (CRT) details:Reasons for RT interruptions and dose reductions/ withdrawals; | frequency distribution of reasons to interrupt or stop RT | up to 6 month |
| Chemoradiotherapy (CRT) details:· RT: doses, fractionation, planning, selective and elective irradiation of lymph nodes | frequency distribution of the number of RT fractions received | up to 6 month |
| Chemoradiotherapy (CRT) details:· Type of platinum-based chemotherapy used | Frequency distribution of number chemotherapy courses, of types of platinum chemotherapy used | up to 6 month |
| Chemoradiotherapy (CRT) details: For sCRT: duration between ChT and RT | For sCRT: range and median number of chemotherapy courses, median days between chemotherapy and radiotherapy | up to 6 month |
| Chemoradiotherapy (CRT) details | · For ChT: number of chemotherapy courses | up to 6 month |
| Chemoradiotherapy (CRT) details for SCLC | Frequency distribution of the number of RT and doses received per day (2x1,5 Gy or 1X2 or 3 Gy) | Up to 6 months |
| Balashikha |
| Russia |
| Research Site | Barnaul | Russia |
| Research Site | Grozny | Russia |
| Research Site | Irkutsk | Russia |
| Research Site | Ivanovo | 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 | 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 | Tula | Russia |
| Research Site | Tver' | Russia |
| Research Site | 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 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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