Biological-guided Metronomic Chemotherapy as Maintenance Strategy in Metastatic Colorectal Cancer

Before the start of induction therapy:

Inclusion Criteria:

• Histological proof of colorectal cancer (in case of a single metastasis, histological or cytological proof of this lesion should be obtained);
• Distant metastases which are unresectable (patients with only local recurrence are not eligible);
• 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;

Exclusion criteria

• Prior adjuvant treatment for stage II/III colorectal cancer ending within 6 months before the start of induction treatment
• Any prior adjuvant treatment after resection of distant metastases
• Previous systemic treatment for advanced disease

At randomisation:

Inclusion criteria:

• WHO performance status 0-1 (Karnofsky PS > 70%);
• Disease evaluation with proven SD, PR or CR according to RECIST after first-line induction treatment;
• Laboratory values obtained ≤ 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;
• Age: 18-75 years;
• Negative pregnancy test in women with childbearing potential;
• Expected adequacy of follow-up;
• Institutional Review Board approval;
• Written informed consent Exclusion criteria
• Chronic active infection;
• Any other concurrent severe or uncontrolled disease preventing the safe administration of study drugs;