Zinc Supplement in Metastatic Colorectal Cancer Patients Receiving Regorafenib: Phase II Prospective Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 主要终点
- Difference in grade 2 or worse HFSR incidence within the first 8 weeks of regorafenib treatment between mCRC patients who receive regorafenib treatment with or without zinc supplementation
研究概览
简要总结
Phase II randomized trial to investigate whether supplementation of zinc decreases the incidence of HFSR that occurs after treatment of tyrosine kinase inhibitor, regorafenib.
详细描述
This study is aimed to investigate the effect of zinc supplementation on improving regorafenib treatment safety and efficacy in patients with metastatic colorectal cancer (mCRC). The difference in grade 2 or worse hand-foot skin reaction (HFSR) incidence within the first 8 weeks of regorafenib treatment between two arms will be examined as the primary objective.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with mCRC who have been previously treated with, or are not considered candidates for, other locally approved standard treatment(s) and for whom the decision has been made per investigator's routine treatment practice to prescribe regorafenib
- •Ability to understand and willingness to sign written Informed Consent Form (ICF)
排除标准
- •Patients participating in an investigational program with interventions outside of routine clinical practice
- •Patients with baseline Zinc level above 120 ug/dL
- •Patients with known allergy to Zinc supplementation
- •Pregnancy
- •Patients who are unsuitable for study participation, based on investigator's discretion
研究组 & 干预措施
Regorafenib treatment with Zn supplement
Patients enrolled in this arm received regorafenib with zinc supplementation to examine if zinc supplementation can decrease the incidence of grade 2 or higher HFSR.
干预措施: Regorafenib (Drug)
Regorafenib treatment with Zn supplement
Patients enrolled in this arm received regorafenib with zinc supplementation to examine if zinc supplementation can decrease the incidence of grade 2 or higher HFSR.
干预措施: Zinc gluconate supplement (Dietary Supplement)
Regorafenib treatment only
Patients enrolled in this arm received regorafenib without zinc supplementation, which is the standard treatment of patients of metastatic colorectal cancer who failed previous standard therapy.
干预措施: Regorafenib (Drug)
结局指标
主要结局
Difference in grade 2 or worse HFSR incidence within the first 8 weeks of regorafenib treatment between mCRC patients who receive regorafenib treatment with or without zinc supplementation
时间窗: 8 weeks
Percentages
次要结局
- Percentage of regorafenib dose reduction(Through study completion, estimated 2 years)
- Disease control rate (DCR)(Through study completion, estimated 2 years)
- Percentage of zinc deficiency before and after regorafenib treatment at weeks 4(4 weeks)
- Objective tumor response rate (ORR)(Through study completion, estimated 2 years)
- Overall survival (OS)(Through study completion, estimated 2 years)
- Duration of treatment of regorafenib (DoT)(through study completion, estimated 2 years)
- Percentage of zinc deficiency before and after regorafenib treatment at weeks 8(8 weeks)
- Progression Free Survival (PFS)(Through study completion, estimated 2 years)
研究者
Yeh Chun-Nan
Professor and Director, Division of General Surgery
Chang Gung Memorial Hospital