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 Multimodal Recurrence Scoring System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 488
- 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 multimodal recurrence scoring system that was successfully categorise patients with stage III clear cell renal cell carcinoma into high-risk and low-risk groups with Hazard Ratio (HR) of 6.21. 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.
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
- 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 Eastern Cooperative Oncology Group (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
- •Patients who have previously received neoadjuvant therapy
- •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
sunitinib 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent.
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 to 10 years
Disease free survival (DFS) was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death.
次要结局
- Overall survival(From the date of registration to up to 10 years)
研究者
Jun-Hang Luo
Professor
First Affiliated Hospital, Sun Yat-Sen University