Pelvic and Para-aortic Lymphadenectomy in Patients With Stage I or II Endometrial Cancer With High Risk of Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 640
- 试验地点
- 120
- 主要终点
- Overall survival (OS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed EC of clinical stages T1b and T2 (all histological types) and stage T1a G3 type 1 (endometrioid, endometriod with squamous differentiation, mucinous) or type 2 tumors (any percentage of serous or clear cell component) or carcinosarcoma
- •a) no previous surgery concerning EC (primary surgery) or b) surgery after hysterectomy (e.g. for presumed low risk endometrial cancer) is allowed within 8 weeks after hysterectomy if no LNE was performed (secondary surgery)
- •absence of bulky lymph nodes
- •performance status ECOG 0-1
- •age 18 - 75 years
- •written informed consent
- •adequate compliance
排除标准
- •stage pT1a, G1 or G2 tumors of type 1 histology
- •sarcomas (except for carcinosarcoma = malignant mixed Müllerian tumor)
- •EC of FIGO stages III or IV (except for microscopical lymph node metastases)
- •evidence of extrauterine disease by visual inspection
- •recurrent EC
- •preceding chemo-, radio, or endocrine therapy for EC
- •any concomitant disease not allowing surgery including lymphadenectomy and/or chemotherapy
- •any medical history indicating excessive peri-operative risk
- •any current medication containing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents)
- •any known disorder or circumstances making participation in trial and follow-up questionable. Insufficient compliance is expected.
- •patients with second malignancies if disease or treatment might have an impact on the patient's prognosis
- •known HIV-infection or AIDS
- •simultaneous participation in other clinical trials if not permitted by the steering committee (translational or QoL studies not interfering with the objectives of ECLAT are allowed)
结局指标
主要结局
Overall survival (OS)
时间窗: 60 months
Impact of systematic pelvic and para-aortic lymphadenectomy (LNE) on overall survival in EC patients with high risk of recurrence
次要结局
- Assessment of serious complications(during surgery, at hospital discharge, day 60, 6 months, 9 months, 12 months)
- Disease free survival (DFS)(3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 42 months, 48 months, 54 months, 60 months)
- Number of resected lymph nodes(during surgery)
- Disease specific survival (DSS)(3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 42 months, 48 months, 54 months, 60 months)
- EORTC QLQ-C30(Baseline, at hospital discharge, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 42 months, 48 months, 54 months, 60 months)
- EORTC QLQ-EN24(Baseline, at hospital discharge, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 42 months, 48 months, 54 months, 60 months)