NL-OMON50614已完成3 期
The role of surgery of the primary tumour with few or -absent symptoms in patients with synchronous unresectable metastases of colorectal cancer, a randomized phase III study - CAIRO4
Dutch Colorectal Cancer Group0 个研究点目标入组 176 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 176
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Histological proof of colorectal cancer
- •Resectable primary tumour in situ with unresectable distant metastases
- •No indication for neo-adjuvant (chemo)radiation.
- •No severe signs or symptoms related to the primary tumour (i.e. severe
- •bleeding, obstruction, severe abdominal pain) that require immediate surgery or
- •other symptomatic treatment (e.g. stenting) (see 6.4 for exceptions)
- •No prior systemic treatment for advanced disease
- •Age >= 18 years
- •WHO performance status 0-2
- •Laboratory values obtained <= 4 weeks prior to randomization: Adequate bone
- •marrow function (Hb * 6.0 mmol/L, absolute neutrophil count * 1.5 x 109/L,
- •platelets * 100 x 109/L), renal function (serum creatinine <= 1.5x ULN and
- •creatinine clearance, Cockroft formula, * 30 ml/min), liver function (serum
- •bilirubin <= 2 x ULN, serum transaminases <= 3 x ULN without presence of liver
- •metastases or <= 5x ULN with presence of liver metastases)
- •Expected adequacy of follow-up
- •Written informed consent
- •Unidimensionally measurable disease (* 1 cm on CT scan or * 2 cm on chest
- •X-ray; liver ultrasound is not allowed, according to RECIST 1.1)
- •CT abdomen performed <= 4 weeks prior to randomization
排除标准
- •Pregnancy, lactation
- •Unresectable primary tumour (i.e. neurovascular encasement, substantial
- •ingrowth in pancreatic head), or any condition preventing the safety or
- •feasibility of resection of the primary tumour, i.e. massive ascites or
- •extensive peritoneal disease
- •Second primary malignancy within the past 5 years with the exception of
- •adequately treated in situ carcinoma of any organ or basal cell carcinoma of
- •Any medical condition that prevents the safe administration of systemic
- •Previous intolerance of fluoropyrimidines, known complete dihydropyrimidine
- •dehydrogenase (DPD) deficiency
- •(Planned) radical resection of all metastatic disease
- •Uncontrolled hypertension, i.e. values consistently > 150/100 mmHg
- •Use of * 3 antihypertensive drugs
- •Significant cardiovascular disease < 1 yr before randomization (symptomatic
- •congestive heart failure, myocardial infarction, unstable angina pectoris,
- •serious uncontrolled cardiac arrhythmia, cerebrovascular event)
- •Chronic active infection
- •Concurrent treatment with any other anti-cancer therapy as described per
研究者
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