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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Small Cell Lung Carcinoma

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU de Brest
  • Landerneau, France, 29800
    • Hôpital de Landerneau
  • Quimper, France, 29000
    • CHIC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults (age ≥18 years) with histologically or cytologically SCLC diagnosis was confirmed who received at least one cycle with a epirubicin-paclitaxel doublet treated between January 2010 and December 2020 in one of the three centers (Brest University Hospital Center, Quimper Hospital Center and Landerneau Hospital Center)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Time from epirubicin-paclitaxel regimen initiation to disease progression (according to Response Evaluation Criteria In Solid Tumors v1.1) or death from any cause	through study completion, an average of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2021
• Primary Completion (Actual): December 12, 2021
• Study Completion (Actual): December 12, 2021

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Epirubicin; Paclitaxel; Real-life; Small-cell Lung Cancer; Cerebral Efficacy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: 29BRC21.0086 - EPITAX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three month and ending five years following the publication
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No