Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cantonal Hospital of St. Gallen
With
University of Bern
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Cytological or histological proven diagnosis of colorectal cancer, metastatic or inoperable advanced disease, not amenable to curative therapy
Measurable disease, defined as at least one lesion (outside of irradiated areas) that can be measured in at least one dimension as ≥ 10 mm (≥ 15 mm in case of lymph nodes) according to RECIST v1.1
Tumor either wild-type KRAS or KRAS-mutated
Indication for the therapeutic use of continuous intravenous 5FU over 48 hours ("deGramont" regimen) or oral Cp, either alone or in combination with other anticancer drugs (including monoclonal antibodies or other molecularly-targeted drugs)
All regimens may be combined with anti-VEGF or anti-EGFR targeted treatment such as bevacizumab or cetuximab
Patients receive first-line systemic treatment (previous adjuvant chemotherapy is allowed, previous rectal radiochemotherapy is allowed if completed \>/=1 months before registration to the study)
Written informed consent before registration to the trial
The patient is willing to undergo pharmacogenetic and pharmacokinetic sampling and analysis
WHO performance status 0 or 1
Female or male patients \>18 years of age
Adequate organ function (ANC, PLT, bilirubin 2xULN, creatinine clearance)
You may not be if
Known hypersensitivity to trial drug or any compounds of the drug
Pregnant or breastfeeding women
Patients with cerebral and/or leptomeningeal metastases are eligible, unless there is a need for treatment with steroids
Risk of rapid deterioration due to tumor symptoms or tumor complications
Severe or uncontrolled cardiovascular disease (e.g. ACS, cardiac failure NYHA III or IV, clinically relevant myopathy, history of myocardial infarction within the last 12 months, significant arrhythmias)
Concurrent use of reversible or irreversible DPD-inhibitors, including brivudin, sorivudin, eniluracil 5-chloro-2,4-dihydroxypyridine or with substances interfering with the immunoassay, including theophylline and theobromine.
Concurrent severe uncontrolled medical illness (judged by the investigator) which could impair the ability of the patient to participate in the trial
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