EUCTR2016-001193-15-DK进行中（未招募）1 期
Folic acid supplement versus placebo for treating mucositis adverse events in metastatic renal cell carcinoma patients receiving targeted therapy (FASTERCC). A randomized, double-blind, phase II trial from the Danish renal cancer group (DARENCA study-4). - Folic Acid Supplement for Treating adverse Events in metastatic Renal Cell Carcinoma (FASTERCC).
Department of Oncology, Aarhus University Hospital0 个研究点目标入组 100 人开始时间: 2016年5月18日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patients displaying CTCAE =2 mucositis during TKI or mTOR inhibitor treatment.
- •2.Signed written informed consent obtained prior to any study specific procedures.
- •3.Patient must be willing and able to comply with the protocol.
- •4.Age > 18.
- •5.Biopsy proven locally advanced or metastatic renal cell carcinoma.
- •6.Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating.
- •7.Fertile women of childbearing potential (<2 years after last menstruation) and men must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgical sterilization).
- •8.Karnofsky Performance status > 60%.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Known hypersensitivity to folic acid
研究者
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