Neoadjuvant Chemotherapy in Upper Tract Urothelial Carcinoma : a Retrospective Multicentric Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Pathological response rate
研究概览
简要总结
Upper tract urothelial carcinoma incidence is about 1 /100000/year. These tumors are mostly diagnosed at an invasive stage and the standard treatment is a total nephroureterectomy.
In this population, indication of perioperative chemotherapy is still discussed. The benefit of platinum-based adjuvant chemotherapy was recently confirmed by the prospective trial POUT for pT2-T4 N0-3 M0 tumors with an improvement in recurrence-free survival of 51% in the chemotherapy arm.
However, in this situation, use of adjuvant Cisplatin-based chemotherapy may be limited by the deterioration of renal function due to renal surgery.
There are currently no recommendations on the place of neoadjuvant chemotherapy (NAC) with controversial results.
Moreover, the impact on renal function of the NAC-NUT treatment sequence has so far been little studied.
The aim of this study is to improve scientific knowledge about neoadjuvant chemotherapy in upper tract urothelial carcinoma eligible to a curative surgery. The investigators will evaluate the benefit of NAC on pathological response, overall survival and progression-free survival in a large multicentric cohort. In addition, the investigators will assess the impact of NAC on renal function at a distance from curative surgery will allow the evaluation of its specific toxicity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age
- •Male or female
- •Upper excretory tract tumors
- •Localized or locally advanced stage (N0 to N1)
- •Eligible for curative surgery
- •Have received neoadjuvant or primary chemotherapy
- •Neoadjuvant chemotherapy treatment received between 2010 and 2020.
排除标准
- •Patient's opposition to the research
- •UTUC not eligible for curative surgery
- •Locally advanced UTUC ≥ N2 and/or metastatic.
结局指标
主要结局
Pathological response rate
时间窗: immediately after the end of chemotherapy treatment
Pathological response rate on the surgical specimen after 4 to 6 cycles of chemotherapy (each cycle is 14 days or 21 days according to chemotherapy treatment).
次要结局
- Progression free-survival(at 4 years)
- Radiological response rate(immediately after the end of chemotherapy treatment)
- residual renal function assessed by creatinine clearance (mL/min)(at 3 months after curative surgery)