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img  2:  Phase III trial to confirm the superiority of pelvic and para-aortic lymphadenectomy to pelvic lymphadenectomy alone for endometrial cancer: Japan Clinical Oncology Group Study 1412 (SEPAL-P3).
 
著者: Hidemichi Watari, Hiroshi Katayama, Taro Shibata, Kimio Ushijima, Toyomi Satoh, Takashi Onda, Daisuke Aoki, Haruhiko Fukuda, Nobuo Yaegashi, Noriaki Sakuragi, Gynecologic Cancer Study Group of the Japan Clinical Oncology Group
雑誌名: Jpn J Clin Oncol. 2017 Oct 1;47(10):986-990. doi: 10.1093/jjco/hyx108.
Abstract/Text To prospectively investigate the survival benefit of para-aortic lymphadenectomy, we launched a new study, the JCOG1412. This is a randomized Phase III trial to confirm the superiority of pelvic and para-aortic lymphadenectomy to pelvic lymphadenectomy alone. Patients corresponding to possible FIGO Stage IB, II, IIIA, IIIB, and a part of IIIC1 are eligible for the first registration before surgery. Next, those patients without evidence of para-aortic lymph node metastasis and multiple pelvic lymph node metastasis during surgery will be included in the second registration and randomized to either the pelvic lymphadenectomy alone arm or the pelvic and para-aortic lymphadenectomy arm. After the initial surgery, patients with post-operative recurrence risks receive adjuvant chemotherapy. The primary endpoint is overall survival. Secondary endpoints include relapse-free survival, short-term surgical outcomes, adverse events related to adjuvant chemotherapy and recurrence patterns. This trial has been registered at the UMIN Clinical Trials Registry [http://www.umin.ac.jp/ctr/index.htm] as UMIN000025399.

© The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
PMID 28981739  Jpn J Clin Oncol. 2017 Oct 1;47(10):986-990. doi: 10.1093/jjco/hyx108.
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