Metastatic Colorectal Cancer (RAS-wildtype) After Response to First-line Treatment With FOLFIR Plus Cetuximab
Status:
Recruiting
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
Summary
The FIRE-4 study aims to define a treatment concept for patients with RAS wild-type tumours,
optimised with regard to overall survival. The first-line treatment will be conducted with
FOLFIRI plus cetuximab, which resulted in a significantly prolonged overall survival versus
bevacizumab in the FIRE-3 study. Following initial progression (PD1) it is recommended that
the treatment be continued with FOLFOX plus bevacizumab, as this concept led to significantly
prolonged survival in the E3200 study. Owing to the encouraging results of the Santini study
, a cetuximab rechallenge in combination with irinotecan-based chemotherapy is to be
performed as part of the third-line treatment in patients who showed a response defined
according to RECIST 1.1 during the first-line treatment (tumour diameter < -30%) or presented
with stable tumour disease for at least 6 months (tumour diameter +20 to -30%). The concept
of the ideal sequence has not yet been studied to date in a clinical trial.