A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer

Summary

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.

Conditions

• Small Cell Lung Cancer

Interventions

DRUG

Topotecan

1.5 mg/m\^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more

DRUG

Belotecan

0.5 mg/m\^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical

  lead INDUSTRY

Principal Investigators

• Heung Tae Kim, M.D., Ph.D · National Cancer Center

• Jin Hyoung Kang, M.D., Ph.D · The Catholic University of Korea Seoul St. Marys Hospital

• Jin Young Kim, M.D., Ph.D · Keimyung University Dongsan Medical Center

• Dong-Wan Kim, M.D., Ph.D · Seoul National University Hospital

• Sang-We Kim, M.D., Ph.D · Asan Medical Center

• Hye Ryeon Kim, M.D., Ph.D · Yonsei Cancer Center

• Jin Hyuk Choi, M.D., Ph.D · Ajou University School of Medicine

• Ki Hyeong Lee, M.D., Ph.D · Chungbuk National University Hospital

• Ho Jung An, M.D., Ph.D · St. Vincents Hospital

• Chi Hoon Maeng, M.D., Ph.D · Kyung Hee University Medical Hospital

• Jin-Soo Kim, M.D., Ph.D · SMG-SNU Boramae Medical Center

• Joung Soon Jang, M.D., Ph.D · Choung Ang University Hospital

• Bong Seog Kim, M.D., Ph.D · Seoul Veterans Hospital

• Joo-Hang Kim, .D., Ph.D · CHA Bundang Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-09-30

Primary Completion

2017-12-31

Completion

2018-03-31

Countries

• South Korea

Study Locations