Clinical trial · Interventional
Topotecan Plus Cisplatin Versus Etoposide Plus Cisplatin In 1st Line Extensive Disease Small Cell Lung Cancer
An Open-Label, Multicentre, Randomised, Phase III Study Comparing Topotecan/Cisplatin and Topotecan/Etoposide Versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients With Extensive Disease-Small Cell Lung Cancer
NCT00320359CI-TRIAL-00026207completedPhase 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)
Evaluation of intravenous Topotecan + Cisplatin as a potential new standard of care in 1st line Small Cell Lung Cancer
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 |
|---|---|---|---|
| Lung Cancer, Small Cell | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravenous etoposide/cisplatin | Drug | — | UNRESOLVED |
| Intravenous topotecan/cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- Cisplatin 75 mg/m2 i.v., day 1, Etoposide 100 mg/m2 i.v., days 1-3
- interventionNames
- Drug: Intravenous etoposide/cisplatin
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Topotecan 1 mg/ m2, i.v., days 1-5 Cisplatin 75 mg/m2 i.v., days 5
- interventionNames
- Drug: Intravenous topotecan/cisplatin
Primary outcomes (1)
- measure
- Median overall survival time of participants
- timeFrame
- Up to 1 year after randomization of the last patient
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Evaluable extensive small cell lung cancer, extensive disease. * Eastern Cooperative Oncology Group (ECOG) performance status \< 2. * Life expectancy \> 3 months. * Fit to receive any of the treatments. * No prior chemotherapy. * Written informed consent. Exclusion Criteria: * Extensive disease treatable with radiotherapy. * Past or current history of other malignant disease. * Prior chemotherapy. * Pregnancy, lactating or lack of effective contraception. * Concurrent severe medical problems other than small cell lung cancer. * Patients with central nervous system metastases receiving more than 12 mg /day dexamethasone or equivalent to control symptoms.
References
Publications (0)
Data not yet available
No reference posted for this study.