Clinical trial · Interventional
Study Of Irinotecan Hydrochloride (Campto(R)) And Cisplatin Versus Etoposide And Cisplatin In Small Cell Lung Cancer
Open Label, Randomised Multicentre Phase III Study Of Irinotecan Hydrochloride (Campto (Registered)) And Cisplatin Versus Etoposide And Cisplatin In Chemotherapy Naive Patients With Extensive Disease - Small Cell Lung Cancer
NCT00143455CI-TRIAL-00003163completedPhase 3Results postedClinicalTrials.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)
To compare the effects of irinotecan hydrochloride with cisplatin to the "standard" regimen etoposide plus cisplatin on overall survival, in chemotherapy-naive patients with newly diagnosed Extensive Disease-Small Cell Lung Cancer (ED-SCLC).
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 | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Etoposide + cisplatin | Drug | — | UNRESOLVED |
| Irinotecan + cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- B
- interventionNames
- Drug: Etoposide + cisplatin
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: Irinotecan + cisplatin
Primary outcomes (2)
- measure
- Overall Survival (OS) for the Full Analysis Population (FAP)
- timeFrame
- Baseline to date of death (every 3 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment)
- description
- OS was defined as the time from date of randomization to date of death due to any cause. For a subject not expiring, the OS time was censored on the last date of contact that they were known to be alive. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley's method.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically proven Small Cell Lung Cancer (SCLC) * WHO performance status : 0, 1 Exclusion Criteria: * No previous radiotherapy is allowed except on bone metastases when newly diagnosed. Radiotherapy is not allowed for vena cava syndrome, a stent is recommended ; * No prior surgery on the primary tumor except for palliative purpose (stent for vena cava syndrome).
References
Publications (0)
Data not yet available
No reference posted for this study.