Continuous or Intermittent Cetuximab Plus FOLFIRI as First-line Treatment in RAS/BRAF Wild-type mCRC Patients

This is a combined multicenter, randomized phase III clinical trial and interventional clinical performance study according to IVDR investigating the superiority of intermittent application of FOLFIRI plus cetuximab followed by a scheduled treatment pause compared to continuous treatment with FOLFIRI plus cetuximab until disease progression or unacceptable toxicity. This study is accompanied by a translational research program. This study protocol is driven by a CTR-conform question and primary endpoint, the PFS from randomization to progression on treatment at 12 months, and supplemented by a separate, complementary, interventional clinical performance study to assess ctDNA as biomarker of early disease progression as a key secondary endpoint. Details regarding the IVD part are specified in the complementary interventional clinical performance study protocol. Treatment is planned until progression, death or unacceptable toxicity. Patients are followed up with regard to survival and if applicable subsequent anti - cancer treatments until death or -after end of study treatment- for at least 3 years after start of treatment, whichever date is earlier.