S-1 (Teysuno) versus capecitabine with or without bevacizumab, as first line treatment in patients with metastazised bowel cancer. A study of the Duthch colorectal Cancer Group.
- Conditions
- Metastatic Colorectal CancerMedDRA version: 17.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-002147-28-NL
- Lead Sponsor
- Dutch Colorectal Cancer Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
• 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
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method