EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,545
- 试验地点
- 991
- 主要终点
- 5-year Recurrence-free Survival (RFS)
研究概览
简要总结
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.
PURPOSE: This phase III trial is studying everolimus to see how well it works in treating patients with kidney cancer who have undergone surgery.
详细描述
OBJECTIVES:
Primary
- to compare recurrence-free survival in renal carcinoma patients randomly assigned to 54 weeks of everolimus versus 54 weeks of placebo after nephrectomy or partial nephrectomy.
Secondary
- To compare the overall survival of patients treated with everolimus vs placebo.
- To compare qualitative and quantitative toxicity between the two study arms.
- To bank tissue and biologic specimens for future study of molecular biomarkers relevant to the AKT/mTOR and other pathways implicated in the pathogenesis of renal carcinoma and to investigate their potential predictive and prognostic value.
- To bank blood specimens for the future study of the relationship between steady-state trough levels of everolimus and relevant side effects (lymphopenia, infection, hyperglycemia, hypercholesterolemia, hypertriglyceridemia) in patients treated on this study with everolimus.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
干预措施: everolimus (Drug)
Arm II
Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
干预措施: placebo (Other)
结局指标
主要结局
5-year Recurrence-free Survival (RFS)
时间窗: 5 years from registration
To compare 5-year recurrence-free survival in renal carcinoma participants randomly assigned to 54 weeks of everolimus versus 54 weeks of placebo after nephrectomy or partial nephrectomy. Recurrence-free survival is defined as From date of registration to date of first documentation of recurrence or death due to any cause. Participants last known to be alive and recurrence-free are censored at date of last contact. Recurrence is defined as positive cytology or biopsy and/or progressively enlarging solid mass as evidenced by CT or MRI scans.
次要结局
- Frequency and Severity of Toxicities(Up to 54 weeks of treatment)
- 5-year Overall Survival (OS)(5 years from registration)