Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
2 years survival
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Seppo W Langer, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dept. of Oncology, Rigshospitalet, Copenhagen
Authority:
Denmark: Danish Medicines Agency
Study ID:
DOLG7
NCT ID:
NCT00812266
Start Date:
January 2006
Completion Date:
January 2015
Related Keywords:
- Extensive Disease
- First-Line
- Small Cell Lung Cancer
- SCLC
- Extensive disease
- topotecan
- Lung Neoplasms
- Small Cell Lung Carcinoma