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CompletedNCT06550518EPITAXUpdated Aug 13, 2024

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

An observational study in Advanced Small Cell Lung Carcinoma, sponsored by University Hospital, Brest. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-13.

Sponsored by University Hospital, Brest · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
29
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Advanced Small Cell Lung Carcinoma

Keywords

  • Small-cell Lung Cancer
  • Epirubicin
  • Paclitaxel
  • Cerebral Efficacy
  • Real-life
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 29 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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)

Inclusion criteria

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

Exclusion criteria

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
29 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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

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

Secondary outcomes

  1. Overall survival

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

    Time frame: 1 year

  2. Objective response rate

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

    Time frame: 1 year

  3. Disease control rate

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

    Time frame: 1 year

  4. Intracranial control rate

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

    Time frame: 1 year

  5. Toxicities

    According to Common Toxicity Criteria for Adverse Events version 5.0.

    Time frame: 1 year

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Study locations

3 sites
  • CHRU de Brest
    Brest, 29609, France
  • Hôpital de Landerneau
    Landerneau, 29800, France
  • CHIC
    Quimper, 29000, France
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References and documents

Individual participant data

Plan to share: Yes — All collected data that underlie results in a publication

Supporting information: Study protocol

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06550518
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
Aug 13, 2024
Start date
May 4, 2021
Primary completion
Dec 12, 2021
Completion
Dec 12, 2021
Last update
Aug 13, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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