EUCTR2016-000628-24-GB进行中（未招募）1 期
A randomised placebo-controlled phase III trial of the effect of the omega-3 fatty acid eicosapentaenoic acid (EPA) on colorectal cancer recurrence and survival after surgery for resectable liver metastases - EMT2: EPA for Metastasis Trial 2
niversity of Leeds0 个研究点目标入组 448 人开始时间: 2018年5月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 448
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
- •Aged =18 years
- •Able to provide written informed consent
- •Histological diagnosis of colorectal cancer with evidence of liver metastases
- •Planned liver resection surgery for colorectal cancer liver metastasis with curative intent, including repeat ‘re-do’ colorectal cancer liver metastasis liver surgery (a second independent resection for a separate colorectal cancer liver recurrence)
- •Intention to receive =2 weeks treatment with IMP prior to colorectal cancer liver metastasis surgery
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Incurable extra-hepatic metastases
- •Current (in the last 2 months) or planned regular (>3 doses per week) use of O3FA-containing supplements, including fish oil and cod-liver oil supplements
- •Fish/seafood allergy
- •<2 weeks before planned CRCLM surgery
- •Inability to comply with trial treatment and follow-up schedule
- •Known bleeding tendency/condition (e.g. von Willebrand disease)
- •A previous malignancy within the last 5 years other than:
- •? - colorectal cancer
- •? - non-melanoma skin cancer where treatment consisted of resection only or radiotherapy
- •? - ductal carcinoma in situ (DCIS) where treatment consisted of resection only
- •? - cervical carcinoma in situ where treatment consisted of resection only
- •? - superficial bladder carcinoma where treatment consisted of resection only
- •A previous malignancy where the patient has been disease-free for =5 years
- •Pregnant or breastfeeding women or women of childbearing potential not willing to use effective contraceptive measures. Women of childbearing potential are defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile.
- •Men defined as fertile (post-pubescent and not permanently sterile by bilateral orchidectomy) and not willing to use effective contraceptive measures if appropriate.
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