EUCTR2014-004299-41-ES进行中（未招募）1 期
ERbitux MEtastatic colorectal cancer Strategy Study: A phase III randomized two arm study with FOLFIRI + Cetuximab until disease progression compared to FOLFIRI + Cetuximab for 8 cycles followed by Cetuximab alone until disease progression in first line treatment of patients with RAS and BRAF wild type metastatic colorectal cancer - ERMES
Dipartimento di Scienze mediche Oncologia Medica Policlinico Gemelli0 个研究点目标入组 600 人开始时间: 2016年9月9日最近更新:
适应症
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
- 600
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
- •Histologically proven diagnosis of colorectal adenocarcinoma
- •Diagnosis of metastatic disease
- •Hepatic metastases which are deemed to be amenable for surgical resection, but for which the pharmacological treatment could be considered useful before proceeding to the intervention, upon clinical judgment.
- •RAS and BRAF wild-type
- •Measurable disease according to RECIST criteria v1.1
- •Male or female pts > 18 years of age
- •ECOG Performance Status = 2
- •Life expectancy of at least 3 months
- •Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment
- •If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment
- •If female and of childbearing potential, or if male, agreement to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method).
- •Signed informed consent obtained at screening
- •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 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Any contraindication to use cetuximab, irinotecan, 5-FU or folinic acid
- •Active uncontrolled infections or active disseminated intravascular coagulation
- •Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
- •Pregnancy.
- •Breastfeeding.
- •Grade III or IV heart failure (NYHA classification)
- •Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or without stenting within the past 12 months before inclusion in the study
- •Cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin
- •Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study
- •Previous chemotherapy for colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before entering the study
- •Participation in a clinical study or experimental drug treatment within 30 days prior to study inclusion or during participation in the study
- •Known or clinically suspected brain metastases
- •History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea
- •Severe, non-healing wounds, ulcers or bone fractures
- •Uncontrolled hypertension
- •Marked proteinuria (nephrotic syndrome)
- •Known DPD deficiency (specific screening not required)
- •Known history of alcohol or drug abuse
- •A significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study
- •Absent or restricted legal capacity
研究者
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