| Trial name or title |
FIRE‐4.5 |
| Methods |
Phase III randomised controlled trial |
| Participants |
People with KRAS/NRAS WT, BRAFV600E MT mCRC |
| Interventions |
Arm A: the combination of FOLFOXIRI and cetuximab. Arm B: the combination of FOLFOXIRI and bevacizumab |
| Outcomes |
Primary outcome: response rate. Secondary outcomes: PFS, OS, early tumour shrinkage and depth of response, molecular biomarkers for prediction of sensitivity and secondary resistance of an anti‐EGFR treatment with cetuximab (including tumour biopsies and liquid biopsies from blood samples), analysis of tumour marker evolution (CEA and CA 19‐9), safety and tolerability of treatment |
| Starting date |
September 2016 |
| Contact information |
Studiensekretariat, Klinikum der Ludwig‐Maximilians‐Univ. München, Klinikum Großhadern, 0049894400 72208, Matthias.Wolff@med.uni‐muenchen.de |
| Notes |
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