A Multi-site, Open, Perspective Study of Prognostic Value and Benefit From Adjuvant Targeted Therapy of Stage III Clear Cell Renal Cell Carcinoma Based on a CpG-methylation-based Assay
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Disease free survival
研究概览
简要总结
Whether patients with stage III clear cell renal cell carcinoma(ccRCC) should receive adjuvant targeted therapy or not is still on debate. The investigators invented a assay consisting of 5 CpGs: cg00396667（PITX1）, cg18815943 （FOXE3）, cg03890877（TWF2）, cg07611000 （EHBP1L1）and cg14391855（RIN1）that was successfully categorise patients with stage III clear cell renal cell carcinoma into high-risk and low-risk groups with Harzard Ratio(HR) of 4.93. Here the investigators randomly assign assay-defined high risk patients of locally advanced ccRCC into adjuvant targeted therapy group and observation group.Disease free survival and overall survival are the end points of observation.
详细描述
The investigators' CpG-methylation-based assay contains 5 CpGs: cg00396667（PITX1）, cg18815943 （FOXE3）, cg03890877（TWF2）, cg07611000 （EHBP1L1）and cg14391855（RIN1）. The investigators evaluate the CpG methylation status of surgical specimens using pyrosequencing and calculate their risk score[risk score=(0.0066×PITX1)+(0.0034×FOXE3)-(0.027×TWF2) -(0.018×EHBP1L1)-(0.03×RIN1)], risk score ≥-0.1 as assay-defined high risk status and risk score<-0.1 as assay-defined low risk status. The investigators randomly assign assay-defined high risk patients of stage III ccRCC into intervention group and control group. The intervention group should receive adjuvant targeted therapy while the control group deserve observation. Primary endpoint is the disease free survival and overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The informed consent has been obtained from the patient.
- •With confirmed diagnosis of stage III clear cell renal cell carcinoma
- •With moderate/good ECOG health rating (PS): 0-1 score.
- •The patient receive no anti-cancer treatment before primary surgery.
- •The patient receive radical operation for renal cancer with negative margin.
排除标准
- •With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
- •With bad compliance or contraindication to enrollment.
- •Pregnant woman or lactating woman.
- •With contraindication to receive adjuvant targeted therapy.
研究组 & 干预措施
A (Intervention group,sunitinib)
Beginning 4-12 weeks following radical nephrectomy, patients receive sunitinib malate PO QD for 4 weeks
干预措施: sunitinib (Drug)
结局指标
主要结局
Disease free survival
时间窗: From the date of registration to up to10 years
次要结局
- Overall survival(From the date of registration to up to10 years)
研究者
Jun-Hang Luo
Professor
First Affiliated Hospital, Sun Yat-Sen University