Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Dutch Colorectal Cancer Group
With
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
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
CT scan abdomen and CT thorax/X-thorax performed ≤ 4 weeks prior to randomization
You may not be if
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
Requirement of neoadjuvant (chmo)radiation therapy
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 the skin
Any medical condition that prevents the safe administration of systemic treatment
Previous intolerance of fluoropyrimidines, known dihydropyrimidine dehydrogenase (DPD) deficiency
Planned radical resection of all metastatic disease
Uncontrolled hypertension, i.e. values consistently \> 150/100 mmHg
