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Completed

NCT Number: NCT06550518

Real-life Second-line Epirubicin-Paclitaxel Regimen as Treatment of Relapsed Small-Cell Lung Cancer : EpiTax Study.

Initial chemosensitivity is known concerning SCLC but relapse is almost systematic, especially at a metastatic stage. Brain metastasis are identified around 40 to 50% during the evolution of the disease. Concerning the efficacy of epirubicin combined with paclitaxel from the second-line treatment, data is lacking more particularly about specific response on brain metastasis.

In this retrospective multicentric observational study in real life conditions, we try to evaluate systemic and specific cerebral efficacy and safety of a regimen combining epirubicin and paclitaxel in patients treated between 2010 and 2020 for a small cell lung carcinoma from the second-line treatment.

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Key information

Conditions

Advanced Small Cell Lung Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Brest, Brest, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults (age ≥18 years)
  • Histologically or cytologically SCLC diagnosis
  • Treated with epirubicin-paclitaxel doublet between January 2010 and December 2020

Exclusion criteria

  • Opposition to participate registered
  • Patients under legal protection
  • Patients afflicted by another subtype of lung carcinomas
  • SCLC not treated with the epirubicin-paclitaxel doublet

Treatment and study plan

Primary outcomes

  1. Progression-free survival

    Time frame: through study completion, an average of 1 year

    Time from epirubicin-paclitaxel regimen initiation to disease progression (according to Response Evaluation Criteria In Solid Tumors v1.1) or death from any cause

Secondary outcomes

  1. Overall survival

    Time frame: 1 year

    Time from epirubicin-paclitaxel regimen initiation to death from any cause

  2. Objective response rate

    Time frame: 1 year

    Complete response or partial response (according to Response Evaluation Criteria In Solid Tumors v1.1)

  3. Disease control rate

    Time frame: 1 year

    Objective response rate and stable disease (according to Response Evaluation Criteria In Solid Tumors v1.1)

  4. Intracranial control rate

    Time frame: 1 year

    Objective response rate and stable disease (according to Response Evaluation Criteria In Solid Tumors v1.1)

  5. Toxicities

    Time frame: 1 year

    According to Common Toxicity Criteria for Adverse Events version 5.0.

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Real-life Second-line Epirubicin-Paclitaxel Regimen as Treatment of Relapsed Small-Cell Lung Cancer : EpiTax Study

Acronym: EPITAX

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 13, 2024
Registry last updated
Aug 13, 2024

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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