Abstract
There have been very limited numbers of investigator-initiated cancer clinical trials for Pharmaceuticals and medical Devices agency (PMDA; Japanese FDA) approval in Japan. Under this situation, we planed and started to prepare to conduct a trial collaborated with the US National Cancer Institute (NCI) / Cancer Therapy Evaluation Program (CTEP) in 2008. The study is a collective effort between Keio University and St. Luke's International Hospital and The University of Texas MD Anderson Cancer Center, which are the sister institutions.
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