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

Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00812266
• Other study ID #: DOLG7
• Secondary ID: DOLG7
• Status: Terminated
• Phase: Phase 3
• First received: December 19, 2008
• Last updated: January 23, 2016
• Start date: January 2006
• Est. completion date: January 2015

Study information

• Verified date: January 2016
• Source: Danish Oncological Lung Cancer Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 281
• Est. completion date: January 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Extensive Disease
• First-Line
• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• topotecan + cisplatin
topotecan IV 2 mg/sqm d1-3 + cisplatin IV 50 mg/sqm d3 q3W
• Etoposide + carboplatin
Etoposide 120 mg/sqm IV d 1-3 + carboplatin AUC 5 d1 q3W

Locations

Country	Name	City	State
Denmark	Dept. Oncology, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Danish Oncological Lung Cancer Group

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2 years survival		2 years	Yes
Secondary	Response rates		2 years	Yes