Amrubicin Study for Elderly Patients With Extensive-disease Small-cell Lung Cancer (ED-SCLC)
Phase 3
Terminated
- Conditions
- Small-cell Lung Cancer
- Registration Number
- NCT00286169
- Lead Sponsor
- Sumitomo Pharma Co., Ltd.
- Brief Summary
The purpose of this study is to compare the efficacy and toxicity of amrubicin with carboplatin plus etoposide in elderly patients with extensive-disease small-cell lung cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 130
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Time to progression Objective tumor response Frequency and severity of adverse events Quality of Life (QOL: EuroQOL, FACT-L-LCS)
Trial Locations
- Locations (8)
Shikoku Region Site
🇯🇵Shikoku, Japan
Kinki Region Site
🇯🇵Kinki, Japan
Hokkaido Region Site
🇯🇵Hokkaido, Japan
Chugoku Region Site
🇯🇵Chugoku, Japan
Kanto Region Site
🇯🇵Kanto, Japan
Kyushu Region Site
🇯🇵Kyushu, Japan
Tohoku Region Site
🇯🇵Tohoku, Japan
Chubu Region Site
🇯🇵Chubu, Japan