Clinical trial · Interventional
Randomized Study of Cisplatin-Etoposide Versus an Etoposide Regimen Without Cisplatin in Extensive Small-Cell Lung Cancer
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
NCT00658580CI-TRIAL-00016853completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Carcinoma, Extensive Disease | Lung Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin + etoposide | Drug | — | UNRESOLVED |
| Epirubicin + ifosfamide + etoposide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- Every 3 weeks intravenous cisplatin plus etoposide
- interventionNames
- Drug: Cisplatin + etoposide
- type
- EXPERIMENTAL
- label
- B
- description
- Every 3 weeks intravenous epirubicin plus ifosfamide plus etoposide
- interventionNames
- Drug: Epirubicin + ifosfamide + etoposide
Primary outcomes (1)
- measure
- Survival
- timeFrame
- Survival will be dated from the day of randomisation until death or last follow up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: * 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
References
Publications (1)
- DERIVEDBerghmans 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. PMID 28975084