Prospective Randomized Phase II Trial: Comparing the Prognostic Value of Routine Lymphadenectomy Versus Lymphadenectomy Only for Lymph Nodes Enlargement Found in Preoperative Imaging or During Surgery Undergoing Nephroureterectomy in Patients With Primary Upper Tract Urothelial Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 504
- 试验地点
- 2
- 主要终点
- Disease free survival
研究概览
简要总结
Recent studies showed the therapeutic benefit of lymphadenectomy in advanced stage urothelial carcinoma of the upper urinary tract, but there is still a lack of prospective studies. Thus, the current guideline recommends lymph node dissection for invasive upper tract urothelial carcinoma (UTUC) on the basis of insufficient evidence. Also, the preoperative judgment of muscle invasive pathological stage T 2+,or N+ is difficult from preoperative imaging. In the investigators' clinical practice, the surgeons performed dissection of regional lymph nodes only in patients with enlargement of lymph nodes found in preoperative imaging or during surgery. The aim of this multi-institutional study was to examine the role of lymphadenectomy in urothelial carcinoma of the upper urinary tract.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically diagnosed with upper tract urothelial carcinoma
- •have no distant metastasis
- •have an Eastern Cooperative Oncology Group (ECOG) score 0 to 2
- •expected to receive radical nephroureterectomy
排除标准
- •a prior history of bladder cancer
- •administration of neoadjuvant chemotherapy
- •deny to receive long term follow-up
- •patients with contralateral UTUCs
- •patients with synchronous muscle invasive bladder cancer
研究组 & 干预措施
Routine lymph node dissection (LND) during nephroureterectomy
Template-based LND was carried out in all patients in this group. The anatomical extent of LND is described in previous study. Lymph node specimens were sampled "en bloc" with surrounding adipose tissue, and were sent to pathological examination as individual packets with the surrounding adipose tissue.
干预措施: Routine Template-based lymphadenectomy (Procedure)
LND for lymph nodes enlargement found before or during surgery
LND was carried out only in patients who have lymph nodes enlargement in preoperative imaging (CTU or enhanced MRI) or who were found lymph nodes enlargement during surgery.
干预措施: LND only for lymph nodes enlargement found in preoperative image or during surgery (Procedure)
结局指标
主要结局
Disease free survival
时间窗: 36 month
Disease free survival rate in the 36 month following nephroureterectomy
次要结局
- Cancer specific survival(36 month)
- Overall survival(36 month)
- The recurrence rate of bladder cancer in the 36 month following nephroureterectomy(36 month)
- Perioperative complications rate(90 day)