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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06550518
Acronym
EPITAX
Enrollment
29
Registered
2024-08-13
Start date
2021-05-04
Completion date
2021-12-12
Last updated
2024-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Small Cell Lung Carcinoma

Keywords

Small-cell Lung Cancer, Epirubicin, Paclitaxel, Cerebral Efficacy, Real-life

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.

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Progression-free survivalthrough study completion, an average of 1 yearTime from epirubicin-paclitaxel regimen initiation to disease progression (according to Response Evaluation Criteria In Solid Tumors v1.1) or death from any cause

Secondary

MeasureTime frameDescription
Overall survival1 yearTime from epirubicin-paclitaxel regimen initiation to death from any cause
Objective response rate1 yearComplete response or partial response (according to Response Evaluation Criteria In Solid Tumors v1.1)
Disease control rate1 yearObjective response rate and stable disease (according to Response Evaluation Criteria In Solid Tumors v1.1)
Intracranial control rate1 yearObjective response rate and stable disease (according to Response Evaluation Criteria In Solid Tumors v1.1)
Toxicities1 yearAccording to Common Toxicity Criteria for Adverse Events version 5.0.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026