EUCTR2013-004952-39-NL进行中（未招募）1 期
eo-adjuvant chemotherapy followed by surgery versus surgery alone in high-risk patients with resectable colorectal liver metastasesThe CHARISMA randomized multicenter clinical trial - CHARISMA
Erasmus MC Cancer Institute0 个研究点目标入组 224 人开始时间: 2014年7月23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
- 224
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
- •Age = 18 years.
- •ECOG performance status 0 or 1.
- •Histologically confirmed primary colorectal carcinoma. Primary colorectal carcinomas to be included are:
- •1. Previously resected histologically proven colorectal carcinoma
- •2. Coloncarcinoma still in situ, deemed suitable for resection at the time of liver surgery
- •3. Rectal carcinoma still in situ, requiring no neo-adjuvant radiotherapy, deemed suitable for resection at the time of liver surgery
- •4. Rectal carcinoma still in situ, requiring short-course neo-adjuvant radiotherapy, deemed suitable for resection at the time of liver surgery
- •Radiologically confirmed and resectable liver metastasis of colorectal cancer after surgery.
- •Clinical risk score of 3-5 (Fong et al.).
- •Adequate bone marrow, liver and renal function as assessed by laboratory requirements to be conducted within 15 days prior to randomization.
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 179
排除标准
- •Prior adjuvant chemotherapy for the primary colorectal carcinoma given <6 months prior to detection of the liver metastases.
- •Prior non colorectal malignancies, except for patients with basal or squamous cell carcinoma of the skin, or patients with carcinoma in situ of the cervix.
- •Presence of extrahepatic disease
- •Locally advanced rectal cancer in situ requiring long-course pre-operative chemoradiotherapy
- •Major surgical procedure < 4 weeks prior to randomization.
- •Females with a positive pregnancy test (within 14 days before treatment start).
- •History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake.
- •Clinically significant (i.e. active) cardiovascular disease e.g. cerebrovascular accidents (= 6 months prior to randomization), myocardial infarction (= 1 year prior to randomization), uncontrolled hypertension while receiving chronic medication, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhytmia requiring medication.
- •Serious, non-healing wound, ulcer, or bone fracture.
- •Serious intercurrent infections (uncontrolled or requiring treatment).
- •Current or recent (within the 28 days prior to randomization) treatment with another investigational drug or participation in another investigational study.
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
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