Advanced Small Cell Lung CarcinomaEPITAXNCT06550518
Real-life Second-line Epirubicin-Paclitaxel Regimen as Treatment of Relapsed Small-Cell Lung Cancer : EpiTax Study.
An observational study of Advanced Small Cell Lung Carcinoma, run by University Hospital, Brest at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Small Cell Lung Carcinoma
- How many people
- 29 participants
- Where
- 3 sitesFrance
- Study dates
- 4 May 2021to 12 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- Adults (age ≥18 years)
- Histologically or cytologically SCLC diagnosis
- Treated with epirubicin-paclitaxel doublet between January 2010 and December 2020
Who cannot join
- Opposition to participate registered
- Patients under legal protection
- Patients afflicted by another subtype of lung carcinomas
- SCLC not treated with the epirubicin-paclitaxel doublet
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHRU de Brest
Brest, 29609
Hôpital de Landerneau
Landerneau, 29800
CHIC
Quimper, 29000
About this study
Official title: 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.
- Conditions
- Advanced Small Cell Lung Carcinoma
- Keywords
- Small-cell Lung Cancer, Epirubicin, Paclitaxel, Cerebral Efficacy, Real-life
- Medical subject headings
- Small Cell Lung Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Overall survival
Time from epirubicin-paclitaxel regimen initiation to death from any cause
Measured: 1 year
Objective response rate
Complete response or partial response (according to Response Evaluation Criteria In Solid Tumors v1.1)
Measured: 1 year
Disease control rate
Objective response rate and stable disease (according to Response Evaluation Criteria In Solid Tumors v1.1)
Measured: 1 year
Intracranial control rate
Objective response rate and stable disease (according to Response Evaluation Criteria In Solid Tumors v1.1)
Measured: 1 year
Toxicities
According to Common Toxicity Criteria for Adverse Events version 5.0.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start4 May 2021
- Primary completion12 Dec 2021
- Study completion12 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550518
- Sponsor's protocol ID
- 29BRC21.0086 - EPITAX
- Acronym
- EPITAX
- Status last verified
- Aug 2024
- First submitted
- 18 Jun 2021
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Second-line Epirubicin-Paclitaxel Regimen as Treatment of Relapsed Small-Cell Lung Cancer : EpiTax Study
- ClinicalTrials.gov ID
- NCT06550518
- Acronym / sponsor ID
- EPITAX / 29BRC21.0086 - EPITAX
- Conditions
- Advanced Small Cell Lung Carcinoma
- Keywords
- Small-cell Lung Cancer, Epirubicin, Paclitaxel, Cerebral Efficacy, Real-life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 12 Dec 2021 (actual)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- Adults (age ≥18 years)
- Histologically or cytologically SCLC diagnosis
- Treated with epirubicin-paclitaxel doublet between January 2010 and December 2020
Key exclusion criteria (4 listed)
- Opposition to participate registered
- Patients under legal protection
- Patients afflicted by another subtype of lung carcinomas
- SCLC not treated with the epirubicin-paclitaxel doublet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
Overall survival
Time frame: 1 year
Objective response rate
Time frame: 1 year
Disease control rate
Time frame: 1 year
Intracranial control rate
Time frame: 1 year
Toxicities
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Advanced Small Cell Lung Carcinoma
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Active, not recruitingPhase 2
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RecruitingPhase 3
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RecruitingPhase 2
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Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Small Cell Lung Carcinoma, run by University Hospital, Brest at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.