FOLFOXIRI Plus Cetuximab vs. FOLFOXIRI Plus Bevacizumab 1st-line in BRAF-mutated mCRC
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
Once randomisation has been completed, the study treatment should be started preferably
immediately; at the latest within one week following randomisation.
The patients will be randomised in a ratio of 1:2 to the following two treatment arms.
Patients in both treatment arms will receive standard chemotherapy with FOLFOXIRI as
background treatment, which can be de-escalated to FOLFIRI in case of toxicity.
Standard arm A:
The patient will be treated with FOLFOXIRI plus bevacizumab for up to 12 cycles (24 weeks) or
until progression (if the latter occurs before completing the 12 cycles). Within the 12
cycles, the FOLFOXIRI plus bevacizumab regimen may be de-escalated, owing to toxicity, to
FOLFIRI and bevacizumab at the treating physician's discretion.
After 12 cycles of the study treatment, a switch to a maintenance regimen with a
fluoropyrimidine (5-FU infusion or capecitabine) plus bevacizumab, administered until
progression occurs, is recommended. The recommended maintenance phase of the study is not
part of the study treatment. However, maintenance therapy will be counted as first-line
therapy.
Experimental arm B:
The patient will be treated with FOLFOXIRI plus weekly administration of cetuximab for up to
12 cycles (24 weeks) or until progression (if the latter occurs before completing the 12
cycles). Within the 12 cycles, the FOLFOXIRI plus cetuximab regimen may be de-escalated owing
to toxicity, to FOLFIRI and cetuximab at the treating physician's discretion.
After 12 cycles, a switch to a maintenance regimen with 5-FU and cetuximab or with irinotecan
and cetuximab, administered until progression occurs, is recommended. The recommended
maintenance phase of the study is not part of the study treatment. However, maintenance
therapy will be counted as first-line therapy.