A Randomized Open Label Multicenter Phase II Study of First Line Therapy With Sorafenib in Association With IL-2 vs Sorafenib Alone in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
The ROSORC trial is a randomized study comparing the efficacy of a new association (sorafenib and IL-2) versus the standard therapy (sorafenib) in patients affected by different histotypes of metastatic RCC. This study is a first line therapy for the advanced disease. The primary objective is the progression free survival (PFS) in the 2 arms of therapy and the secondary objective is the overall survival (OS) and the response rate (RR) and the safety profile of the combination compared to sorafenib alone.
详细描述
Patients will be allocated in 2 groups:
ARM A - Sorafenib 400 mg twice daily continuously and low dose of IL-2 administered s.c.
ARM B - Sorafenib alone at the same dosage used in the previous arm
The trial is stratified according to the MSKCC prognostic model (low intermediate high risk) and histology (Clear cell vs other histotypes). The main inclusion criteria are: cytohistological diagnosis of RCC, measurable disease as RECIST criteria, signed written informed consent, life expectancy of greater than 3 months.
The efficacy and safety analysis will be performed on an intent to treat population.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytohistological diagnosis of RCC
- •Written informed consent
- •Measurable disease according to RECIST criteria
- •Age >= 18 years
- •Karnofsky PS >= 60%
- •Life expectancy of greater than 3 months
排除标准
- •Prior medical treatment for metastatic RCC
- •Brain metastasis or spinal cord compression
- •Chronic treatment with corticosteroids
- •Uncontrolled hypertension
研究组 & 干预措施
1
Sorafenib 400 bid + IL-2 3 MU per 5 day/week for 2 weeks every 4
干预措施: Nexavar (Sorafenib) (Drug)
1
Sorafenib 400 bid + IL-2 3 MU per 5 day/week for 2 weeks every 4
干预措施: IL-2 (Drug)
2
Sorafenib 400 mg bid
干预措施: Nexavar (Sorafenib) (Drug)
结局指标
主要结局
PFS
时间窗: 2 years
次要结局
未报告次要终点