P097 (0105) IMPLEMENTING AN EFFECTIVE PRE-ACCRUAL QUALITY ASSURANCE PROGRAMME IN THE UK TO ENSURE ACCURACY AND CONSISTENCY OF RADIOTHERAPY CONTOURING FOR PAEDIATRIC HODGKIN'S LYMPHOMA WITHIN THE EURONET-PHL-C2 TRIAL (EUDRACT 2012–004053–88)

doi: 10.1097/01.HS9.0000547942.37392.36
Pediatric Hodgkin Lymphoma
Free

P. Díez1, E. Gallop-Evans2, D. J. Cutter3, Y. C. Chang4, S. Sivabalasingham4, T. Ajithkumar5, D. L. Hedegaard6, J. Hayward6, S. Daw4

1National Radiotherapy Trials Quality Assurance Group (RTTQA), Mount Vernon Cancer Centre, Northwood, UK,2Velindre Cancer Centre, Cardiff, UK,3Oxford Cancer & Haematology Centre, Churchill Hospital, Oxford, UK,4University College London Hospital, London, UK,5Addenbrookes Hospital, Cambridge, UK,6Cancer Research UK Clinical Trials Unit, Birmingham, UK

EuroNet-PHL-C2 is the European Network of Paediatric Hodgkin's Lymphoma second International Inter-Group Study for Classical Hodgkin's Lymphoma in Children & Adolescents. It is a multicentre, randomised, controlled, phase III trial to reduce the indication for radiotherapy (RT) and irradiated volumes in newly diagnosed patients without compromising cure rates. An estimated 200 sites worldwide will be participating to recruit ≥2200 patients.

RT tumour delineation guidelines have changed significantly from the previous (C1) study, resulting in a departure from current clinical practice in paediatric lymphoma. Central staging & response assessment is in place to minimise variation across centres; however, there is no prospective central review for RT contouring. In the UK, a pre-accrual quality assurance (QA) programme was deemed essential to monitor correct implementation of changes across all centres ensuring accurate & consistent contouring, and hence compliance with the trial protocol.

The UK National Radiotherapy Trials QA (RTTQA) group in conjunction with the UK reference clinical oncologist have implemented a comprehensive QA programme that includes a UK RT guidelines document to complement the trial RT Manual. The pre-accrual QA programme focussed on RT delineation; the main area where inter-departmental variability was expected. An outlining benchmark case and 3 clinical case evaluations were produced to assess clinicians’ understanding of the trial protocol.

Five UK paediatric clinical oncologists were identified to review all outlining benchmark case submissions from recruiting centres. The initial step in the review process was to establish a standard against which these submissions would be assessed. The 5 reviewers completed and submitted the outlining benchmark case and the 3 case evaluations. Inter-clinician variability was found to be large. As a result, a meeting was convened to agree a consensus standard set of contours (both target volumes and organs at risk) and a response template for the case evaluations.

A comprehensive QA programme was devised to ensure protocol compliance as well as accuracy and consistency of treatment across centres recruiting into EuroNet-PHL-C2. The results from this preliminary work has identified large inter-clinician variation in contouring highlighting the need for pre-accrual QA within this complex trial. Consequently, comprehensive outlining QA will continue within the UK as an integral part of the trial.

Copyright © 2018 The Authors. Published by Wolters Kluwer Health Inc., on behalf of the European Hematology Association.