Randomized Phase III Trial of Amrubicin Versus Carboplatin Plus Etoposide in Elderly Patients With Extensive-disease Small-cell Lung Cancer
Phase 3
70 Years
N/A
70 Years
N/A
Not Enrolling
Both
Small-cell Lung Cancer
Both
Small-cell Lung Cancer
Trial Information
Randomized Phase III Trial of Amrubicin Versus Carboplatin Plus Etoposide in Elderly Patients With Extensive-disease Small-cell Lung Cancer
Inclusion Criteria:
- Extensive-disease small-cell lung cancer
- Aged 70 years or older
- Performance status of 0-2
- No prior chemotherapy
Exclusion Criteria:
- Prior therapy for primary lesion
- Pneumonitis and/or pulmonary fibrosis
- Active concomitant malignancy
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
Principal Investigator
Drug Development Division
Investigator Role:
Study Director
Investigator Affiliation:
Dainippon Sumitomo Pharma Co., Ltd.
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
D0702002
NCT ID:
NCT00286169
Start Date:
April 2006
Completion Date:
Related Keywords:
- Small-cell Lung Cancer
- Extensive-disease small-cell lung cancer (ED-SCLC)
- Lung Neoplasms
- Small Cell Lung Carcinoma
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