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

Completed

• Conditions: Advanced Small Cell Lung Carcinoma

• Registration Number: NCT06550518
• Lead Sponsor: University Hospital, Brest

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-04
• Study First Submitted: 2021-06-18
• Primary Completion: 2021-12-12
• Study Completion: 2021-12-12
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-09
• Last Update Submitted: 2024-08-09
• Study First Posted: 2024-08-13
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival	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 Outcome Measures

Name	Time	Method
Overall survival	1 year	Time from epirubicin-paclitaxel regimen initiation to death from any cause
Objective response rate	1 year	Complete response or partial response (according to Response Evaluation Criteria In Solid Tumors v1.1)
Intracranial control rate	1 year	Objective response rate and stable disease (according to Response Evaluation Criteria In Solid Tumors v1.1)
Disease control rate	1 year	Objective response rate and stable disease (according to Response Evaluation Criteria In Solid Tumors v1.1)
Toxicities	1 year	According to Common Toxicity Criteria for Adverse Events version 5.0.

Trial Locations

Locations (3)

CHRU de Brest; 🇫🇷 Brest, France

Hôpital de Landerneau; 🇫🇷 Landerneau, France

CHIC; 🇫🇷 Quimper, France