EUCTR2013-002147-28-NL进行中（未招募）不适用
S-1 versus capecitabine in the first line treatment of metastatic colorectal cancer patients, the SALTO randomised phase III study of the Dutch Colorectal Cancer Group. A safety evaluation of oral fluoropyrimidines. - SALTO
Dutch Colorectal Cancer Group0 个研究点开始时间: 2013年6月18日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Histological proof of colorectal cancer.
- •Distant metastases (patients with only local recurrence are not eligible)
- •Unidimensionally measurable disease (=1 cm on spiral CT scan or =2 cm on chest X-ray; liver ultrasound is not allowed). Serum CEA may not be used as a parameter for disease evaluation.
- •In case of previous radiotherapy, at least one measurable lesion should be located outside the irradiated field.
- •Age = 18 years
- •Planned first line treatment with capecitabine monotherapy with or without bevacizumab.
- •WHO performance status 0-2 (Karnofsky PS =70%);
- •Laboratory values obtained within 2 weeks prior to randomisation:
- •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).
- •Life expectancy > 12 weeks.
- •Negative pregnancy test in women with childbearing potential.
- •Expected adequacy of follow-up.
- •Institutional Review Board approval.
- •Written informed consent.
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •Prior adjuvant treatment for stage II/III colorectal cancer completed within 6 months prior to randomisation.
- •Any prior adjuvant treatment after resection of distant metastases.
- •Any prior systemic treatment for advanced disease.
- •History or clinical signs/symptoms of CNS metastases.
- •History of a second malignancy <5 years with the exception of adequately treated carcinoma of cervix or basal/squamous cell carcinoma of skin.
- •Previous intolerance of capecitabine.
- •Known dihydropyrimidine dehydrogenase (DPD) deficiency or treatment within 4 weeks with DPD inhibitors, including sorivudine or its chemically related analogues such as brivudine.
- •Planned radical resection of metastases after downsizing by systemic treatment.
- •Significant cardiovascular disease < 1 yr before randomisation (symptomatic congestive heart failure, myocardial ischemia or infarction, unstable angina pectoris, serious uncontrolled cardiac arrhythmia, arterial thrombosis, cerebrovascular event, pulmonary embolism).
- •Any significant cardiovascular events during previous fluoropyrimidine therapy.
- •Chronic active infection.
- •Any other concurrent severe or uncontrolled disease preventing the safe administration of study drugs.
- •Any impairment of gastrointestinal function or –disease that may significantly impair the absorption of oral drugs (i.e. uncontrolled nausea, vomiting, diarrhoea (defined as ³CTC grade 2), malabsorption syndrome, bowel obstruction, or inability to swallow tablets).
- •Concomitant treatments: concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation; concurrent treatment with any other anti-cancer therapy.
- •Continuous use of immunosuppressive agents (except the use of corticosteroids as anti-emetic prophylaxis/treatment).
- •In case of treatment with bevacizumab:
- •Uncontrolled hypertension, i.e. consistently > 150/100 mmHg.
- •Use of = 3 antihypertensive drugs.
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