Status:
COMPLETED
Topotecan Plus Cisplatin Versus Etoposide Plus Cisplatin In 1st Line Extensive Disease Small Cell Lung Cancer
Lead Sponsor:
GlaxoSmithKline
Conditions:
Lung Cancer, Small Cell
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Evaluation of intravenous Topotecan + Cisplatin as a potential new standard of care in 1st line Small Cell Lung Cancer
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT00320359
Start Date
August 1 2002
End Date
February 1 2007
Last Update
March 1 2017
Active Locations (79)
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1
GSK Investigational Site
Bludesch, Austria, A-6719
2
GSK Investigational Site
Klagenfurt, Austria, A-9020
3
GSK Investigational Site
Linz, Austria, A-4020
4
GSK Investigational Site
Vienna, Austria, A-1140