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CompletedNCT00658580Updated Feb 12, 2015

Randomized Study of Cisplatin-Etoposide Versus an Etoposide Regimen Without Cisplatin in Extensive Small-Cell Lung Cancer

A Phase 3 interventional study of Cisplatin + etoposide and Epirubicin + ifosfamide + etoposide in Small Cell Lung Carcinoma, Extensive Disease, sponsored by European Lung Cancer Working Party. Completed at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-12.

Sponsored by European Lung Cancer Working Party · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
361
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Small Cell Lung Carcinoma, Extensive Disease

Keywords

  • Small cell lung carcinoma
  • Chemotherapy
  • Phase III randomised study
03

In context

Small Cell Lung Carcinoma

1,203 studies on the registry are indexed under Small Cell Lung Carcinoma; 342 are open to participants now.

This study's enrollment of 361 is above the median of 56 across 1,031 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

European Lung Cancer Working Party is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
361 participants (actual)

Study arms

  • Active comparator
    A

    Every 3 weeks intravenous cisplatin plus etoposide

    Drug: Cisplatin + etoposide

  • Experimental
    B

    Every 3 weeks intravenous epirubicin plus ifosfamide plus etoposide

    Drug: Epirubicin + ifosfamide + etoposide

Interventions

  • DrugCisplatin + etoposide

    Cisplatin 90 mg/m² day 1, every 3 weeks Etoposide 100 mg/m² days 1-3, every 3 weeks

  • DrugEpirubicin + ifosfamide + etoposide

    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

06

What researchers measure

Primary outcomes

  1. Survival

    Time frame: Survival will be dated from the day of randomisation until death or last follow up

Secondary outcomes

  1. Response rate

    Time frame: Every 3 cycles of chemotherapy

  2. Toxicity

    Time frame: After every cycle of chemotherapy

07

Study locations

4 sites
  • Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
    Brussels, 1000, Belgium
  • Department of Pneumology CHRU Lille
    Lille, France
  • Hellenic Cancer Institute - St Savas Oncology Hospital
    Athens, Greece
  • Medical Oncology Hospital de Sagunto
    Valencia, Spain
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00658580
Lead sponsor
European Lung Cancer Working Party
Responsible party
Sponsor
First posted
Apr 15, 2008
Start date
Apr 2000
Primary completion
Dec 2013
Completion
Feb 2015
Last update
Feb 12, 2015

Study contacts

Jean-Paul Sculier, MD, PhD
study chair · European Lung Cancer Working Party

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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