Randomized-Controlled Trial Examining Oncologic and Perioperative Outcomes for Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 8
- 主要终点
- Recurrence-free survival
研究概览
简要总结
The goal of this study is to conduct the first randomized-controlled trial to determine the oncologic efficacy of lymph node dissection in participants with upper tract urothelial cell carcinoma. The main questions it aims to answer are:
- To determine oncologic outcomes, specifically 2-year recurrence-free survival
- To determine other oncologic outcomes including treatment-free, cancer-specific and overall survival
- To determine time to recurrence and recurrence patterns
- To determine use of adjuvant therapies
- To determine perioperative complications
Participants will undergo nephroureterectomy with or without lymph node dissection. Researchers will compare these two groups to determine the oncologic efficacy of performing lymph node dissection.
详细描述
Upper Tract Urothelial Carcinoma (UTUC) is a rare disease with complex management. Some participants with clinically negative nodes may still receive a lymph node dissection (LND) with nephroureterectomy, and currently, no randomized controlled trial exists to evaluate the oncologic efficacy of this practice. According to current American Urologic Association guidelines, Nephroureterectomy is the standard of care intervention for high-risk UTUC and low-risk UTUC is endoscopically unresectable. The aim of the present study is to determine the efficacy, specifically 2-year recurrence-free survival, of lymph node dissection at time of nephroureterectomy for participants with UTUC, compared to no lymph node dissection, as well as examine other oncologic outcomes and complication rates
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults > 18 years
- •Diagnosis of UTUC as determined by upper tract biopsy (either low or high grade)
- •Planned for nephroureterectomy by their urologic surgeon
- •Disease that is ≤cT4, N0M
- •Participants must have complete TNM staging prior to surgery. cT disease can be determined by biopsy of the mass (if biopsy was deep enough) or imaging (CT/MRI). cN and cM stage must be determined by preoperative imaging of the chest, abdomen and pelvis.
- •No concomitant muscle-invasive bladder cancer
- •Subjects must have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Pathologically enlarged lymph nodes suspicious for metastases which would require lymph node dissection regardless of trial (>cN0)
- •Presence of distant metastases
- •Concomitant muscle invasive bladder cancer
- •The participant is in a reduced general condition or has a life-threatening disease.
- •The participant has a psychiatric disorder that precludes them from understanding the consent process.
- •The patient is pregnant
结局指标
主要结局
Recurrence-free survival
时间窗: 2 years post-op
Kaplan-Meier will compare recurrence-free survival time between participants who received LND vs participants who did not receive LND.
次要结局
- Overall Survival(2 years post-op)
- Time to recurrence(2 years post-op)
- Treatment-free survival(2 years post-op)
- Cancer-specific survival(2 years post-op)
- Use of adjuvant therapies(2 years post-op)
- Perioperative complications(2 years post-op)