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[Phase III study of gynecologic cancer in Japan]
1Department of Gynecology, Cancer Institute Hospital, 1-37-1 Kami-ikebukuro, Toshima-ku, Tokyo 170-8455, Japan.
Abstract:
Gynecologic Oncologists in Japan has increasingly much interest in the phase III study to define the standard treatment modality. It is very difficult, however, to conduct a phase III trial because a very few medical staff including doctors have experience and understanding of such studies and also poor understanding of patients to be entered. According to the literature and papers in the meetings, several phase III studies were conducted unexpectedly. I reviewed these data and pointed out the problems included in the studies. The results of these trials and related problems prompted Japanese Gynecologic Oncologists to conduct a high quality phase III study to clarify the standard treatment modality for gynecologic cancer.