An Open-Label, Multicentre, Randomised, Phase III Study Comparing Topotecan/Cisplatin and Topotecan/Etoposide Versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients With Extensive Disease-Small Cell Lung Cancer
Phase 3
18 Years
75 Years
18 Years
75 Years
Not Enrolling
Both
Lung Cancer, Small Cell, Small Cell Lung Cancer
Both
Lung Cancer, Small Cell, Small Cell Lung Cancer
Trial Information
An Open-Label, Multicentre, Randomised, Phase III Study Comparing Topotecan/Cisplatin and Topotecan/Etoposide Versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients With Extensive Disease-Small Cell Lung Cancer
Inclusion Criteria:
- Evaluable extensive small cell lung cancer, extensive disease.
- Eastern Cooperative Oncology Group (ECOG) performance status < 2.
- Life expectancy > 3 months.
- Fit to receive any of the treatments.
- No prior chemotherapy.
- Written informed consent.
Exclusion Criteria:
- Extensive disease treatable with radiotherapy.
- Past or current history of other malignant disease.
- Prior chemotherapy.
- Pregnancy, lactating or lack of effective contraception.
- Concurrent severe medical problems other than small cell lung cancer.
- Patients with central nervous system metastases receiving more than 12 mg /day
dexamethasone or equivalent to control symptoms.
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:
Overall survival
Outcome Time Frame:
Duration of study
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
104864-A/479
NCT ID:
NCT00320359
Start Date:
August 2002
Completion Date:
February 2007
Related Keywords:
- Lung Cancer, Small Cell
- Small Cell Lung Cancer
- First-line Cisplatin
- Small Cell Lung Cancer
- topotecan
- etoposide
- Extensive Disease
- Lung Neoplasms
- Small Cell Lung Carcinoma
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