APHRODITE – A Phase II trial of higher radiotherapy dose in the eradication of early rectal cancer

Trial summary:

APHRODITE is a randomised phase II trial investigating non-surgical management and organ preservation for patients with early rectal cancer who are either unsuitable for radical TME surgery, are likely to have difficulty managing a stoma, or who are suitable for radical TME surgery but have a strong preference for an attempt at organ preservation.

The trial will investigate whether dose escalation (delivering a higher radiation dose to the primary tumour as an integrated “boost”) using intensity-modulated radiation therapy (IMRT) in this patient group can be used to attain a complete clinical response (cCR) at 6 months, with long term tumour control and avoidance of tumour-related morbidity. The cCR will be assessed and compared at 6 months between the treatment groups.

The trial aims to recruit 104 patients randomised 1:2 to either the standard dose arm or the escalated dose arm. Both arms will a radical dose of 50.4Gy to the primary tumour and surrounding mesorectum using IMRT, as well as concurrent chemotherapy. Patients randomised to the escalated dose arm with receive a 62Gy boost to their primary tumour volume.

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 ProcessQA ActivityRequired for TrialAdditional Details
Pre-AccrualFacility Questionnaire
Outlining Benchmark CaseContact RTTQA for details on downloading benchmark case
Planning Benchmark CaseContact RTTQA for details on downloading benchmark case
Dummy Run
During AccrualIndividual Case ReviewProspective: first standard arm patient, first dose-escalation arm patient
Retrospective: selected patients
Data collectionAll patients
QA StreamliningSTAR-TReC

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

Chief investigators: Professor Simon Gollins (Clinical Oncologist, Royal Shrewsbury Hospital) & Dr Ane Appelt (Physicist, Leeds Institute of Medical Research at St James’ University Hospital

Co-RT Lead: Dr Mark Teo (Leeds Cancer Centre, St James’s University Hospital)

Sponsor: Yorkshire Cancer Research

Funder: University of Leeds, aphrodite@leeds.ac.uk