Etude Resume (Retraitement Sunitinib Rein Metastatique)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 61
- 试验地点
- 18
- 主要终点
- Progression Free Survival: Second Line of Treatment
研究概览
简要总结
Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line.
详细描述
A sample size of n = 40 patients will allow to estimate of the median PFS with a precision around 1.8 months (based on data from Rini et al.) This retrospective and prospective study is designed to estimate the effect of Sutent rechallenge.
The PFS (estimated from Kaplan-Meier estimate) will be the primary endpoints. In addition, the effects of sunitinib at the 2 periods of treatment (i.e. first line sunitinib vs. rechallenge) will be compared by Wilcoxon signed-rank test for PFS values and by McNemar test for overall response rate (ORR).
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
- •Histologically documented metastatic RCC containing predominantly clear cell component.
- •Previously received sunitinib in first line, 2 or more antitumor therapies subsequently and then received sunitinib for a second time.
- •At least 1 cycle of sunitinib rechallenge (1 cycle= 4 weeks on/2 weeks off).
- •At least 1 measurable lesion that can be accurately measured in at least 1 dimension with the longest diameter (LD) ³ 10 mm when measured by spiral computerized tomography (CT) (5-mm slice thickness contiguous) or ³ 20 mm when measured by conventional CT (10-mm slice thickness contiguous). The lesion must be ³ 2 times the size of the slice thickness per RECIST criteria.
- •Life expectancy of at least 3 months.
排除标准
- •Patient who didn't receive Sunitinib in first line.
- •Patient who received less than one line of treatment .
结局指标
主要结局
Progression Free Survival: Second Line of Treatment
时间窗: From start of treatment up to 22.9 months
The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= \[(Date of mRCC progression - Start date of the treatment) + 1)\]/ 365.25 x 12. Progression was defined as an increase in visible disease. Second-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus).
Progression Free Survival With Sunitinib as First Line of Therapy
时间窗: From start of treatment up to 66.6 months
The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= \[(Date of mRCC progression - Start date of the treatment) + 1)\]/ 365.25 x 12. Progression was defined as an increase in visible disease.
Progression Free Survival for Re-challenge With Sunitinib
时间窗: From start of treatment up to 52.2 months
The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= \[(Date of mRCC progression - Start date of the treatment) + 1)\]/ 365.25 x 12. Progression was defined as an increase in visible disease.
Progression Free Survival: Third Line Treatment
时间窗: From start of treatment up to 23.7 months
The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= \[(Date of mRCC progression - Start date of the treatment) + 1)\]/ 365.25 x 12. Progression was defined as an increase in visible disease. Third-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus).
次要结局
- Percentage of Participants With Objective Response(Baseline up to 98.0 months)
- Overall Survival(Baseline up to death or end of study (up to 98.0 months))