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)

Abstract

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.

Keywords: Japan Clinical Oncology Group; endometrial cancer; lymphadenectomy; randomized controlled trial; survival.