Augmenting RadioTherapy in REctal Cancer to Minimise Invasive Surgery (ARTEMIS)

Research summary

ARTEMIS is a phase II,multi-centre,open-label,randomised controlled trial using IMRT/VMAT/TomoTherapy,comparing radiotherapy (SCRT/LCCRT) followed by chemotherapy (FOLFOX/CAPOX),with or without the addition of AN0025 throughout treatment. Eligible patients will have moderate to high-risk rectal cancer where pre-operative chemoradiotherapy (CRT) or total neoadjuvant treatment (TNT) are standard treatment options and who are interested in organ preservation. ARTEMIS uses the Sargent’s three-outcome two-stage comparative design,including an interim analysis for futility. The trial will randomise 140 patients,from 15-20 UK radiotherapy sites,with a 1:1 allocation ratio to receive either SCRT/LCCRT + FOLFOX/CAPOX or SCRT/LCCRT + FOLFOX/CAPOX +AN0025. To ensure balance between the randomised treatment arms and radiotherapy subgroups,the participants will be stratified by radiotherapy regimen (SCRT vs LCCRT) and then by the minimisation factors T-stage,EMVI status and CRM status. The number of patients in SCRT vs LCCRT is expected to be 50/50 split,providing up to 35 patients for each treatment type in each arm. These proportions will be actively monitored with the potential to adapt inclusion to specific RT regimens. Long term endpoints will be measured up to 30 months from the start of treatment.

Principal Investigator

Dr Rebecca Muirhead

Contact us

Email: latephaseoncology@ouh.nhs.uk

IRAS number

1004319