A Randomised Phase III Trial Comparing Hepatic Arterial Injection of Yttrium-90 Resin Microspheres (SIR-spheres) Plus Systemic Maintenance Therapy Versus Systemic Maintenance Therapy Alone for Patients With Unresectable Liver Metastases From Colorectal Cancer Which Are Controlled After Induction Systemic Therapy
试验速览
- 阶段
- 3 期
- 入组人数
- 162
- 试验地点
- 10
- 主要终点
- Time to progression (TTP1 overall)
研究概览
简要总结
The investigators propose to conduct a randomised phase III trial evaluating a maintenance strategy comparing hepatic arterial injection of Yttrium-90 resin microspheres plus continuing simplified chemotherapy with/without targeted therapy versus continuing simplified chemotherapy with/without targeted therapy alone for patient with dominant or exclusive and unresectable liver mCRC controlled after 3-6 months of chemotherapy induction.
详细描述
The aim of the study is to investigate whether an intensified maintenance treatment of SIRT + simplified maintenance chemotherapy has a benefit in terms of time to progression (TTP) compared to simplified chemotherapy maintenance alone, in patients with stable disease after 3-6 months induction therapy. We would like to demonstrate the feasibility and safety of this approach and to investigate if this strategy has the potential to increase the outcome of the patient.
Primary end-point:
- Time to first progression (TTP1 overall)
Secondary end-points:
- Time to global progression (TTP1 + TTP2), Time to second progression (TTP2), TTP1 liver only
- Progression Free Survival (PFS)
- Overall Survival (OS)
- Safety
- Ro resection rate
- Quality of Life
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 99 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
A: systemic chemotherapy LV5FU2 alone
Modified LV5FU2 as described in protocol (6.2.1) D1-2 +/- bevacizumab or cetuximab or panitumumab (according its previous use) every 2 weeks
干预措施: systemic chemotherapy LV5FU2 (Drug)
B:SIR-spheres+systemic chemotherapy LV5FU2
ARM B: (Hepatic Arterial Infusion) HAI-90Y radioembolization (SIR-spheres injection) + modified LV5FU2 +/- bevacizumab or cetuximab or panitumumab according its previous use (refer to protocol).
干预措施: HAI-90Y radioembolization (SIR-spheres injection) (Device)
结局指标
主要结局
Time to progression (TTP1 overall)
时间窗: Up to 36 months
Time to first progression (TTP1 overall)
次要结局
- Time to global progression (TTP1 + TTP2)(Up to 42 months)
- Quality of life(Up to 42 months)
- Overall Survival (OS)(Up to 42 months)
- PFS(Up to 42 months)
- R0 resection rate(Up to 42 months)
- Safety(Up to 42 months)
研究者
Prof. Marc Peeters
Professor
Universiteit Antwerpen