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Active, not recruiting

NCT Number: NCT05887011

CRT( Chemo-Radiation Therapy) Patterns and Short-term Outcomes on Unresectable NSCLC and SCLC in Routine Practices in Russia

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Unresectable /Inoperable Locally Advanced (Stage II-III) NSCLC and Locally Advanced LS-SCLC (Stage I-III) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Arkhangelsk, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. Chemoradiotherapy (CRT) details

    Time frame: up to 6 month

    · % of induction chemotherapy,

  2. 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

    Time frame: 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

  3. Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC

    Time frame: up to 6 month

    Frequency distribution of each diagnostic approach applied;

  4. Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC

    Time frame: up to 6 month

    Median time between the date patient first came to oncology center and the date of examination (by each approach);

  5. Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC

    Time frame: up to 6 month

    Median time between the date of examination and date of start of CRT (by each approach);

  6. Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC

    Time frame: up to 6 month

    Frequency distribution of results by categories (for example, staging, size, location, etc.) for each approach.

  7. Chemoradiotherapy (CRT) details: concurrent CRT vs sequential CRT

    Time frame: up to 6 month

    Frequency distribution of patients who receive concurrent or sequential CRT

  8. Chemoradiotherapy (CRT) details: presence of interruptions

    Time frame: up to 6 month

    % of CRT interruptions

  9. Chemoradiotherapy (CRT) details: number of interruptions

    Time frame: up to 6 month

    average number of interruptions per patients

  10. Chemoradiotherapy (CRT) details: durations of interruptions

    Time frame: up to 6 month

    median interruption duration (days) (based on mean duration per patient)

  11. Chemoradiotherapy (CRT) details:Reasons for RT interruptions and dose reductions/ withdrawals;

    Time frame: up to 6 month

    frequency distribution of reasons to interrupt or stop RT

  12. Chemoradiotherapy (CRT) details:· RT: doses, fractionation, planning, selective and elective irradiation of lymph nodes

    Time frame: up to 6 month

    frequency distribution of the number of RT fractions received

  13. Chemoradiotherapy (CRT) details:· Type of platinum-based chemotherapy used

    Time frame: up to 6 month

    Frequency distribution of number chemotherapy courses, of types of platinum chemotherapy used

  14. Chemoradiotherapy (CRT) details: For sCRT: duration between ChT and RT

    Time frame: up to 6 month

    For sCRT: range and median number of chemotherapy courses, median days between chemotherapy and radiotherapy

  15. Chemoradiotherapy (CRT) details

    Time frame: up to 6 month

    · For ChT: number of chemotherapy courses

  16. Chemoradiotherapy (CRT) details for SCLC

    Time frame: Up to 6 months

    Frequency distribution of the number of RT and doses received per day (2x1,5 Gy or 1X2 or 3 Gy)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

National Multicentre Non-interventional Study to Assess CRT Patterns and Short-term Outcomes on Unresectable NSCLC and SCLC in Routine Practices in Russia

Acronym: PASSAT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 2, 2023
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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