子宮内膜がんリンパ節郭清術の臨床試験

基本情報

NCT ID: NCT03438474
ステータス: 募集中
試験のフェーズ: 該当なし
試験タイプ: 介入
目標被験者数: 640
治験依頼者名: Philipps University Marburg

概要

The primary aim of this trial is to ascertain whether or not systematic pelvic and para-aortic lymphadenectomy (LNE) does have a significant impact on overall survival (OS) in patients with endometrial cancer (EC) FIGO Stages I or II and high risk of recurrence. Secondary aims will be to evaluate the effect of LNE on disease free survival (DFS) and quality of life, as well as the complications and side effects of LNE and the number of resected lymphnodes. 640 patients with histologically confirmed EC with high risk of recurrence (stage pT1b - pT2, all histological subtypes; pT1a, G3 endometrioid or serous or clear cell EC or carcinosarcomas) will be randomized. In Arm A, a total hysterectomy and bilateral salpingo-oophorectomy and in case of serous or clear cell EC additionally an omentectomy will be performed. In arm B in addition a systematic pelvic and para-aortic LNE up to the level of the left renal vein will be performed.

対象疾患

Cancer of Endometrium Stage ICancer of Endometrium Stage II

介入

Standard surgical procedure for endometrial cancer(PROCEDURE)

systematic lymphadenectomy (LNE)(PROCEDURE)

依頼者（Sponsor）

German Cancer Aid(OTHER)

Philipps University Marburg(OTHER)

実施施設 (2)

埼玉医科大学国際医療センター

Saitama, Japan(RECRUITING)

岡山大学病院

Okayama, Japan(RECRUITING)