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Japanese Journal of Clinical Oncology Advance Access published online on October 12, 2009
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyp117
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© The Author (2009). Published by Oxford University Press. All rights reserved

A Phase III Trial of Paclitaxel plus Carboplatin Versus Paclitaxel plus Cisplatin in Stage IVB, Persistent or Recurrent Cervical Cancer: Gynecologic Cancer Study Group/Japan Clinical Oncology Group Study (JCOG0505)

Isamu Saito1, Ryo Kitagawa2, Haruhiko Fukuda1, Taro Shibata1, Noriyuki Katsumata3, Ikuo Konishi4, Hiroyuki Yoshikawa5 and Toshiharu Kamura6

1 Clinical Trial and Practice Support Division, Center for Cancer Control and Information Services, National Cancer Center
2 Department of Gynecology and Obstetrics, Kanto Medical Center, NTT EC
3 Department of Medical Oncology, National Cancer Center Hospital, Tokyo
4 Department of Obstetrics and Gynecology, Kyoto University, Kyoto
5 Department of Obstetrics and Gynecology, Tsukuba University, Ibaraki
6 Department of Obstetrics and Gynecology, Kurume University School of Medicine, Fukuoka, Japan

For reprints and all correspondence: Ryo Kitagawa, Department of Gynecology and Obstetrics, Kanto Medical Center, NTT EC, 5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-0022, Japan. E-mail: kitagawa.ryo{at}east.ntt.co.jp

Received January 5, 2009; accepted August 15, 2009

A randomized controlled trial has been started in Japan to compare the utility of palliative chemotherapy containing paclitaxel and carboplatin (TC) with paclitaxel and cisplatin (TP) as a standard treatment for patients with the newly diagnosed Stage IVB, persistent or recurrent cervical cancer who are not amenable to curative treatment with local therapy. This trial was designed to evaluate the non-inferiority of TC as measured by the number of hospitalized days as an indicator of quality of life (QOL) when compared with TP combination therapy. The primary endpoint is overall survival. Secondary endpoints are progression-free survival, response rates, adverse events, severe adverse events and the proportion of non-hospitalization periods compared with planned treatment periods.

Key Words: cervical cancer • palliative chemotherapy • recurrent • persistent • Stage IVB • cisplatin • carboplatin • paclitaxel


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