TY - JOUR
T1 - Phase III trial to confirm the superiority of pelvic and para-aortic lymphadenectomy to pelvic lymphadenectomy alone for endometrial cancer
T2 - Japan Clinical Oncology Group Study 1412 (SEPAL-P3)
AU - Gynecologic Cancer Study Group of the Japan Clinical Oncology Group
AU - Watari, Hidemichi
AU - Katayama, Hiroshi
AU - Shibata, Taro
AU - Ushijima, Kimio
AU - Satoh, Toyomi
AU - Onda, Takashi
AU - Aoki, Daisuke
AU - Fukuda, Haruhiko
AU - Yaegashi, Nobuo
AU - Sakuragi, Noriaki
N1 - Publisher Copyright:
© The Author 2017. Published by Oxford University Press. All rights reserved.
PY - 2017/10/1
Y1 - 2017/10/1
N2 - 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.
AB - 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.
KW - Endometrial cancer
KW - Japan Clinical Oncology Group
KW - Lymphadenectomy
KW - Randomized controlled trial
KW - Survival
UR - http://www.scopus.com/inward/record.url?scp=85030682605&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85030682605&partnerID=8YFLogxK
U2 - 10.1093/jjco/hyx108
DO - 10.1093/jjco/hyx108
M3 - Article
C2 - 28981739
AN - SCOPUS:85030682605
VL - 47
SP - 986
EP - 990
JO - Japanese Journal of Clinical Oncology
JF - Japanese Journal of Clinical Oncology
SN - 0368-2811
IS - 10
ER -