Unresectable /Inoperable Locally Advanced (Stage II-III) NSCLC and Locally Advanced LS-SCLC (Stage I-III)
Conditions
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | * % of patients with each TNM stage * % of patient with locoregional recurrence and inoperable patients (including patient's refusal) * Median age at the start of CRTs, % male/female, % of patients with comorbidities (and % by comorbidity type by MedDRA SOC/PT), % on concomitant medications, * % of patients by ECOG category; * % of patients with each tumour histology type; * % of patients with known PD-L1 status (and of those - % positive); * % of patients with known EGFR mutation status (and of those % by mutation status). * of patients with SCLC from all patients with locally or locally advanced LC receiving CRT * of patients with each TNM stage among SCLC * of pts with locoregional recurrence and inoperable pts among SCLC (including pt's refusal Median age at the start of CRTs, % male/female, % of patients with comorbidities (and % by comorbidity type by MedDRA SOC/PT), % on concomitant medications among SCLC * of patients by ECOG category among SCLC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chemoradiotherapy (CRT) details | up to 6 month | · % of induction chemotherapy, |
| 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 | up to 6 month | * % of patients with CR, * % of patients with PR, * % of patients with OR (ORR), * % of patients with SD, * % of patients with PD, * % of patients unevaluable for response |
| Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC | up to 6 month | Frequency distribution of each diagnostic approach applied; |
| Chemoradiotherapy (CRT) details: concurrent CRT vs sequential CRT | up to 6 month | Frequency distribution of patients who receive concurrent or sequential CRT |
| Chemoradiotherapy (CRT) details: presence of interruptions | up to 6 month | % of CRT interruptions |
| Chemoradiotherapy (CRT) details: number of interruptions | up to 6 month | average number of interruptions per patients |
| Chemoradiotherapy (CRT) details: durations of interruptions | up to 6 month | median interruption duration (days) (based on mean duration per patient) |
| Chemoradiotherapy (CRT) details:Reasons for RT interruptions and dose reductions/ withdrawals; | up to 6 month | frequency distribution of reasons to interrupt or stop RT |
| Chemoradiotherapy (CRT) details:· RT: doses, fractionation, planning, selective and elective irradiation of lymph nodes | up to 6 month | frequency distribution of the number of RT fractions received |
| Chemoradiotherapy (CRT) details:· Type of platinum-based chemotherapy used | up to 6 month | Frequency distribution of number chemotherapy courses, of types of platinum chemotherapy used |
| Chemoradiotherapy (CRT) details: For sCRT: duration between ChT and RT | up to 6 month | For sCRT: range and median number of chemotherapy courses, median days between chemotherapy and radiotherapy |
| Chemoradiotherapy (CRT) details for SCLC | Up to 6 months | Frequency distribution of the number of RT and doses received per day (2x1,5 Gy or 1X2 or 3 Gy) |
Countries
Russia
Outcome results
None listed