Small Cell Lung Carcinoma, Extensive DiseasePhase 3NCT00658580
Randomized Study of Cisplatin-Etoposide Versus an Etoposide Regimen Without Cisplatin in Extensive Small-Cell Lung Cancer
A Phase 3 study testing Cisplatin + etoposide and Epirubicin + ifosfamide + etoposide in people with Small Cell Lung Carcinoma, Extensive Disease, run by European Lung Cancer Working Party at 4 sites in 4 countries.
Trial summary
The purpose of this study is to determine if a cisplatin-etoposide regimen improves survival in comparison to a regimen containing etoposide and without platinum derivative. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Carcinoma, Extensive Disease
- What is being tested?
- Cisplatin + etoposide and Epirubicin + ifosfamide + etoposide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Apr 2000to Feb 2015
- Phase
- Phase 3
- 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
Who may be able to join
- Histological or cytological diagnosis of small-cell lung cancer
- Extensive disease (i.e. a disease with distant metastases or that cannot be included in a single irradiation field incorporating primary tumour, mediastinum and supraclavicular lymph node(s))
- Availability for participating in the detailed follow-up of the protocol
- Presence of an evaluable or measurable lesion
- Informed consent
Who cannot join
- Prior treatment with chemotherapy, radiotherapy or surgery
- Performance status < 60 on the Karnofsky scale
- A history of prior malignant tumor, except non-melanoma skin cancer or in situ carcinoma of the cervix or a cured cancer (defined as a disease-free interval > 5 years)
- White blood cells < 4000/mm3
- Platelets < 100000/mm3
- Serum bilirubin > 1.5 mg/100 ml
Show all 11Show fewer
- Serum creatinine > 1.3 mg/100 ml and creatinine clearance <60 ml/min
- Recent myocardial infarction (less than 3 months prior to date of diagnosis)
- Congestive cardiac failure or cardiac arrhythmia uncontrolled by medical treatment
- Uncontrolled infectious disease
- Serious medical or psychological factors which may prevent adherence to the treatment schedule
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Belgium1 site
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, 1000
About this study
Official title: A Phase III Randomized Study Comparing A Chemotherapy With Cisplatin And Etoposide To A Etoposide Regimen Without Cisplatin For Patients With Extensive Small-Cell Lung Cancer
The purpose of this study is to determine if a cisplatin-etoposide regimen improves survival in comparison to a regimen containing etoposide and without platinum derivative.
- Being tested
- Cisplatin + etoposide, Epirubicin + ifosfamide + etoposide
- Keywords
- Small cell lung carcinoma, Chemotherapy, Phase III randomised study
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin + etoposideDrug
Cisplatin 90 mg/m² day 1, every 3 weeks
Etoposide 100 mg/m² days 1-3, every 3 weeks
Epirubicin + ifosfamide + etoposideDrug
Epirubicin 60 mg/m² day 1, every 3 weeks
Ifosfamide (+ uromitexan) 1.5 g/m² days 1-3, every 3 weeks
Etoposide 100 mg/m² days 1-3, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Every 3 weeks intravenous cisplatin plus etoposide Receives: Drug: Cisplatin + etoposide |
| B | Experimental | Every 3 weeks intravenous epirubicin plus ifosfamide plus etoposide Receives: Drug: Epirubicin + ifosfamide + etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: Survival will be dated from the day of randomisation until death or last follow up
Secondary outcomes (2)
Response rate
Measured: Every 3 cycles of chemotherapy
Toxicity
Measured: After every cycle of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2008 (estimated)
- Study startApr 2000
- Primary completionDec 2013
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung Carcinoma, Extensive DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Lung Cancer Working Party
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Paul Sculier, MD, PhD, Study chair, European Lung Cancer Working Party
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658580
- Sponsor's protocol ID
- ELCWP 01994
- Status last verified
- Feb 2015
- First submitted
- 11 Apr 2008
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Berghmans T, Scherpereel A, Meert AP, Giner V, Lecomte J, Lafitte JJ, Leclercq N, Paesmans M, Sculier JP; European Lung Cancer Working Party (ELCWP). A Phase III Randomized Study Comparing a Chemotherapy with Cisplatin and Etoposide to a Etoposide Regimen without Cisplatin for Patients with Extensive Small-Cell Lung Cancer. Front Oncol. 2017 Sep 19;7:217. doi: 10.3389/fonc.2017.00217. eCollection 2017.
PubMed 28975084
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Study Comparing A Chemotherapy With Cisplatin And Etoposide To A Etoposide Regimen Without Cisplatin For Patients With Extensive Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00658580
- Acronym / sponsor ID
- ELCWP 01994
- Keywords
- Small cell lung carcinoma, Chemotherapy, Phase III randomised study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- European Lung Cancer Working PartyUniversity, hospital or other
- Study start
- Apr 2000
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 15 Apr 2008 (estimated)
- 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.
The purpose of this study is to determine if a cisplatin-etoposide regimen improves survival in comparison to a regimen containing etoposide and without platinum derivative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Cisplatin + etoposideEvery 3 weeks intravenous cisplatin plus etoposide |
| B | Experimental | Drug: Epirubicin + ifosfamide + etoposideEvery 3 weeks intravenous epirubicin plus ifosfamide plus etoposide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histological or cytological diagnosis of small-cell lung cancer
- Extensive disease (i.e. a disease with distant metastases or that cannot be included in a single irradiation field incorporating primary tumour, mediastinum and supraclavicular lymph node(s))
- Availability for participating in the detailed follow-up of the protocol
- Presence of an evaluable or measurable lesion
- Informed consent
Key exclusion criteria (11 listed)
- Prior treatment with chemotherapy, radiotherapy or surgery
- Performance status < 60 on the Karnofsky scale
- A history of prior malignant tumor, except non-melanoma skin cancer or in situ carcinoma of the cervix or a cured cancer (defined as a disease-free interval > 5 years)
- White blood cells < 4000/mm3
- Platelets < 100000/mm3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cisplatin + etoposideCisplatin 90 mg/m² day 1, every 3 weeks Etoposide 100 mg/m² days 1-3, every 3 weeks | Drug | A |
| Epirubicin + ifosfamide + etoposideEpirubicin 60 mg/m² day 1, every 3 weeks Ifosfamide (+ uromitexan) 1.5 g/m² days 1-3, every 3 weeks Etoposide 100 mg/m² days 1-3, every 3 weeks | Drug | B |
Primary outcome
Survival
Time frame: Survival will be dated from the day of randomisation until death or last follow up
2 secondary outcomes
Response rate
Time frame: Every 3 cycles of chemotherapy
Toxicity
Time frame: After every cycle of chemotherapy
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 12 Feb 2015.
- Derived from this study: PubMed 28975084Berghmans T, Scherpereel A, Meert AP, Giner V, Lecomte J, Lafitte JJ, Leclercq N, Paesmans M, Sculier JP; European Lung Cancer Working Party (ELCWP). A Phase III Randomized Study Comparing a Chemotherapy with Cisplatin and Etoposide to a Etoposide Regimen without Cisplatin for Patients with Extensive Small-Cell Lung Cancer. Front Oncol. 2017 Sep 19;7:217. doi: 10.3389/fonc.2017.00217. eCollection 2017.
- Click here for more information on the protocolLink provided by the sponsor.
- Trials registry of the French National Cancer InstituteLink provided by the sponsor.
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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.
Jean-Paul Sculier, MD, PhD study chair
European Lung Cancer Working Party
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cisplatin + etoposide and Epirubicin + ifosfamide + etoposide in people with Small Cell Lung Carcinoma, Extensive Disease, run by European Lung Cancer Working Party at 4 sites in 4 countries.
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 5 inclusion and 11 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 12 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, France, Greece, Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Survival (time frame: Survival will be dated from the day of randomisation until death or last follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00658580, which also lists 1 linked publication.
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 12 Feb 2015.