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

Phase 3

Terminated

• Conditions: Extensive Disease; Small Cell Lung Cancer; First-Line
• Interventions: Drug: Etoposide + carboplatin; Drug: topotecan + cisplatin

• Registration Number: NCT00812266
• Lead Sponsor: Danish Oncological Lung Cancer Group

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

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2008-12-19
• Study First Submitted QC: 2008-12-19
• Study First Posted: 2008-12-22
• Primary Completion: 2013-12
• Study Completion: 2015-01
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-23
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 281

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Etoposide + carboplatin	Etoposide + carboplatin
A	topotecan + cisplatin	Topotecan + cisplatin

Primary Outcome Measures

Name	Time	Method
2 years survival	2 years

Secondary Outcome Measures

Name	Time	Method
Response rates	2 years

Trial Locations

Locations (1)

Dept. Oncology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark