The purpose of this study is to evaluate the efficacy and safety of Belotecan administered 5 days every 3 weeks in comparison to Topotecan in Patients with relapsed small cell lung cancer.
A Phase Ⅱb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan(CamtoBell inj.) or Topotecan in Patients with Relapsed Small Cell Lung Cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
164
Chungbuk University Hospital
Daegu, South Korea
Keimyung University Dongsan Center
Daegu, South Korea
National Cancer Center
Goyang, South Korea
Objectives Response Rate(ORR, %)
The response rate was defined as the test subject who had a complete response (CR) or a partial response (PR) as determined by the 'tumor response evaluation' criteria specified in the research protocol
Time frame: Up to 18weeks
Overall Survival(OS)
Defined as the time from the randomization to the time of death.
Time frame: 7years
Progression Free survival(PFS)
Defined as the elapsed time from the time of randomization to the time of confirmation of progression or the time of death
Time frame: Up to 18weeks
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Asan Medical Center
Seoul, South Korea
CHA Bundang Medical Center
Seoul, South Korea
Chung-Ang University hospital
Seoul, South Korea
Kyung Hee University Medical Hospital
Seoul, South Korea
Seoul National University Boramae Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Seoul St. Marys Hospital
Seoul, South Korea
...and 4 more locations