Phase II Trial of Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients With Small Primary Tumor
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of Radiofrequency ablation in metastatic renal cell carcinoma patients with primary tumor less than 5 cm before medical treatment. Ablation may allow for reduced morbidity and may increase the likelihood of patients receiving systemic therapy.
详细描述
Nephrectomy has become an integral part of the management of patients with metastatic kidney cancer. Performing nephrectomy in these patients is not without risk, however. The very real chance of significant metastatic disease progression during the postoperative period or complication before or during surgery that may prolong postoperative recovery could potentially delay or prevent the administration of systemic therapy in the postoperative period. Patient selection for surgery remains critical for success.
Radiofrequency ablation (RFA) is a medical procedure where tumor is ablated using microwave energy to treat a medical disorder. The benefits of RFA in selected metastatic renal cell carcinoma patients with small primary tumor (<5 cm) will be evaluated in this Phase I/II study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven renal cell carcinoma before RFA;
- •Primary tumor no grater than 5 cm;
- •CT-confirmed metastatic measurable sites;
- •Good prognosis by adapted MSKCC criteria;
- •No treatment for RCC;
排除标准
- 未提供
研究组 & 干预措施
Arm 1
38 patients
干预措施: Radiofrequency ablation; Interferon-alpha (Procedure)
Arm 2
38 patients
干预措施: Radiofrequency ablation; Sunitinib maleate (Procedure)
Arm 3
38 patients
干预措施: Sunitinib maleate (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 11 months
次要结局
- Overall survival(24 months)
- rate of complications(1 year)
- time from the end of ablation to start of medical treatment(3 months)
- Progression-free survival(6 months)
- Quality of life (QOL)(6 months)