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Japanese Journal of Clinical Oncology 2008 38(1):74-77; doi:10.1093/jjco/hym145
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© The Authors (2008). Published by Oxford University Press. All rights reserved

Phase III Trial of Upfront Debulking Surgery Versus Neoadjuvant Chemotherapy for Stage III/IV Ovarian, Tubal and Peritoneal Cancers: Japan Clinical Oncology Group Study JCOG0602

Takashi Onda1,, Koji Matsumoto2, Taro Shibata3, Akihiro Sato3, Haruhiko Fukuda3, Ikuo Konishi4, Toshiharu Kamura5 and Hiroyuki Yoshikawa6

1 Division of Gynecologic Oncology, National Cancer Center Hospital, Tokyo
2 Division of Medical Oncology, Hyogo Cancer Center, Akashi, Hyogo
3 JCOG Data Center, Center for Cancer Control and Information Services, National Cancer Center, Tokyo
4 Department of Obstetrics and Gynecology, Shinshu University, Matsumoto
5 Department of Obstetrics and Gynecology, Kurume University School of Medicine, Kurume, Fukuoka
6 Department of Obstetrics and Gynecology, Institute of Clinical Medicine, University of Tsukuba, Tsukuba, Japan

For reprints and all correspondence: Takashi Onda, Division of Gynecologic Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. E-mail: taonda{at}ncc.go.jp

Received May 11, 2007; accepted October 2, 2007

On the basis of promising results of neoadjuvant chemotherapy (NAC) in our previous study (JCOG0206), we have been performing a Phase III study of treatment starting with NAC versus standard treatment starting with primary debulking surgery (PDS) for Stage III/IV müllerian carcinomas (ovarian, tubal and peritoneal carcinomas) since November 2006. The purposes are to prove the non-inferiority of the efficacy and to show the decrease in adverse effects resulting from reduced surgical invasiveness of treatment starting with NAC. Three hundred patients with advanced müllerian carcinomas will be randomized during 3 years. NAC arm patients undergo four cycles of NAC with paclitaxel plus carboplatin followed by interval debulking surgery and an additional four cycles of postsurgical chemotherapy. Standard arm patients undergo PDS and eight cycles of postsurgical chemotherapy with or without interval debulking surgery. The primary endpoint is overall survival. The major secondary endpoints are the incidence of adverse events and parameters representing surgical invasiveness.

Key Words: ovarian neoplasms • neoadjuvant therapy • interval debulking surgery • primary debulking surgery


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