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

This study has been terminated.
(Slow accrual)
Sponsor:
Information provided by (Responsible Party):
Seppo W. Langer, Danish Oncological Lung Cancer Group
ClinicalTrials.gov Identifier:
NCT00812266
First received: December 19, 2008
Last updated: January 23, 2016
Last verified: January 2016

December 19, 2008
January 23, 2016
January 2006
December 2013   (final data collection date for primary outcome measure)
2 years survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00812266 on ClinicalTrials.gov Archive Site
Response rates [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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
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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Extensive Disease
  • First-Line
  • Small Cell Lung Cancer
  • 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
  • Experimental: A
    Topotecan + cisplatin
    Intervention: Drug: topotecan + cisplatin
  • Active Comparator: B
    Etoposide + carboplatin
    Intervention: Drug: Etoposide + carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
281
January 2015
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00812266
DOLG7, DOLG7
No
Not Provided
Not Provided
Seppo W. Langer, Danish Oncological Lung Cancer Group
Danish Oncological Lung Cancer Group
Not Provided
Principal Investigator: Seppo W Langer, MD PhD Dept. of Oncology, Rigshospitalet, Copenhagen
Danish Oncological Lung Cancer Group
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP