Cetuximab Maintenance Treatment Versus Continuation After Induction Therapy in mCRC

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 either technically unresectable or no chance to reach NED (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;

• Ongoing or planned first line induction therapy with 8 cycles of FOLFIRI or mFOLFOX6.

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

• RAS mutant mCRC

At randomisation:

Inclusion criteria:

• WHO performance status 0-1 (Karnofsky PS > 70%);

• Disease evaluation with proven SD, PR or CR according to RECIST after 8 cycles of FOLFIRI or mFOLFOX6;

• Laboratory values obtained ≤ 2 weeks prior to randomisation: adequate bone marrow function (Hb > 8.0 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 > 24 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;