Trial | NCT00812266  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    281
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.
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 Started
Jan 31
2006
Primary Completion
Dec 31
2013
Study Completion
Jan 31
2015
Last Update
Jan 26
2016
Estimate

Drug topotecan + cisplatin

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

Drug Etoposide + carboplatin

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

A Experimental

Topotecan + cisplatin

B Active Comparator

Etoposide + carboplatin

Criteria 

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
No Results Posted