Topotecan and Cisplatin Versus Etoposide and Carboplatin in 1st Line Treatment of Patients With Small Cell Lung Cancer and Extensive Disease (SCLC-ED)

Randomized Phase III Trial of Topotecan and Cisplatin Versus Etoposide and Carboplatin in the Treatment of Patients With Previously Untreated Small Cell Lung Cancer and Extensive Disease

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00812266

Enrollment

281

Registered

2008-12-22

Start date

2006-01-31

Completion date

2015-01-31

Last updated

2016-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extensive Disease, First-Line, Small Cell Lung Cancer

Keywords

SCLC, Extensive disease, topotecan

Brief summary

Randomised trial comparing standard chemotherapy with carboplatin and etoposide with a combination of topotecan and cisplatin in patients with inoperable lung cancer of small cell type.

Detailed description

Fase III, multicenter randomised trial comparing up to six cycles of carboplatin and etoposide with up to six cycles of topotecan and cisplatin in patients with extensive stage small cell lung cancer and PS 0-3

Interventions

DRUGEtoposide + carboplatin

Etoposide 120 mg/sqm IV d 1-3 + carboplatin AUC 5 d1 q3W

DRUGtopotecan + cisplatin

topotecan IV 2 mg/sqm d1-3 + cisplatin IV 50 mg/sqm d3 q3W

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically confirmed SCLC * Extensive stage * No prior chemotherapy * WHO PS 0-3 * Adequate organ function (liver, kidney) * Adequate hematology (bone marrow) * Informed consent

Exclusion criteria

* PS 4 * Inadequate organ function * Uncontrolled infection * Concomitant major medical contraindications

Design outcomes

Primary

Measure	Time frame
2 years survival	2 years

Secondary

Measure	Time frame
Response rates	2 years

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026