Augmenting RadioTherapy in REctal Cancer to Minimise Invasive Surgery

Trial summary:

ARTEMIS is a randomised phase II trial for patients with moderate to high-risk rectal cancer where pre-operative chemo-RT is a standard treatment option, and are suitable for organ preservation. Patients are randomised 1:1 between 1) standard of care long-course chemo-RT (LCCRT) or short-course chemo-RT (SCCRT) based on clinician choice, and 2) standard of care LCCRT or SCCRT based on clinician choice, with the addition of immunotherapy agent AN0025. Both arms will also receive total neoadjuvant treatment (TNT) in the form of FOLFOX or CAPOX, based on clinician choice. A total of 140 patients will be randomised.

RT QA summary:

All QA activity will be streamlined with previous trial QA, where applicable. Please contact the RTTQA Group directly using the contact details below to discuss.

QA Process	QA Activity	Required for Trial	Additional Details
Pre-Accrual	Facility Questionnaire
	Outlining Benchmark Case
	Planning Benchmark Case
	Dummy Run
During Accrual	Individual Case Review		Prospective: Outlining and planning for first patient. Planning for first boost patient (if not first patient). Retrospective: At least every fifth patient
	Data collection		All plans and CBCT data
Dosimetry
QA Streamlining			Planning only: STAR-TReC, APHRODITE

RTTQA contact: artemisqa.enh-tr@nhs.net

Chief investigator: Professor Simon Gollins (Royal Shrewsbury Hospital) & Professor Mark Saunders (The Christie NHS Foundation Trust)

Sponsor: University of Leeds (artemis@leeds.ac.uk)

Funder: Late Phase Clinical Trial Awards