FOxTROT 4
Status: Open
Title
FOxTROT 4: Efficacy and safety of encorafenib and cetuximab in the neoadjuvant treatment of high-risk early BRAF mutant colorectal cancer.
Description
B-RAF proto-oncogene (BRAF) mutant (BM) colorectal cancer (CC) is associated with inferior prognosis compared to wild-type. In the metastatic setting, emerging precision oncology options are becoming available for BM cancer.
In FOxTROT 4 we will evaluate the efficacy and safety of encorafenib and cetuximab (EC) in the neoadjuvant treatment of patients with highrisk early BRAF mutant colorectal cancer.
We hypothesise that 6 weeks of neoadjuvant treatment with the EC doublet will be safe and result in significant tumour regression compared with 6 weeks of neoadjuvant oxaliplatin and fluoropyrimidine (OxFp) chemotherapy.
Objectives
To demonstrate the activity, safety and short-term clinical effectiveness of neoadjuvant treatment of high-risk early pMMR/MSS BM CC patients with EC compared to neoadjuvant OxFp chemotherapy.
Trial Design
Randomised, phase II, multi-centre, open-label study.
Trial Status
Open
Population
Participants will have locally advanced, but operable, BM CC. Patients will be medically fit with normal renal, hepatic and bone marrow function. There is no fixed age cut-off.
Patients will have tumours with proficient mismatch repair (pMMR)/ microsatellite stable (MSS) and BRAFV600E mutation.