Vienna, Austria

ESTRO 2023

Session Item

May 14
10:30 - 11:30
Translational outputs from clinical trials
Chloe Brooks, United Kingdom;
Jens Overgaard, Denmark
Proffered Papers
11:20 - 11:30
ROAM (EORTC 1308) trial – impact of prospective trial reviews on protocol adherence
Helen Mayles, United Kingdom


ROAM (EORTC 1308) trial – impact of prospective trial reviews on protocol adherence

Helen Mayles1, Brian Haylock2, Michael Jenkinson3

1Clatterbridge Cancer Centre, Physics, Liverpool, United Kingdom; 2Clatterbridge Cancer Centre, Oncology, Liverpool, United Kingdom; 3The Walton Centre, Neurosurgery, Liverpool, United Kingdom

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Purpose or Objective

ROAM (EORTC 1308) is a multinational randomised controlled trial comparing radiotherapy (RT), 60Gy in 30 daily fractions, to active monitoring after complete surgical resection of atypical meningioma. Robust RTQA protocols improve national and international standards so a rigorous RTQA program was set up for this trial, including prospective reviews for all RT patients, as recommended in a previous meningioma trial (EORTC22042-26042). In this analysis we look at common problems and assess the value of prospective patient reviews.

Material and Methods

The UK RTTQA group coordinated the QA and reviewed UK and EORTC centres. An agreement was set up with the Australian QA group (TROG) so that they reviewed the Australian/New Zealand centres and returned all their reports and data to the UK at the end of recruitment.

Consensus contouring and planning guidelines were described in the ROAM RT Protocol and were established at trial development and National Neuro-Oncology meetings.

The pre-trial QA assessment process included the circulation of Benchmark (BM) Cases, an outlining test case and a different pre-outlined test case for planning. A Dummy Run where centres outlined and planned the cases and uploaded them to the QA servers for QA review ensured that this process was done smoothly. A detailed information package was provided and centres were invited to outlining workshops to see outlining demonstrated and to receive practical feedback in the preferred outlining technique and the pitfalls to avoid during planning.

During the trial, Individual Case Reviews (ICR’s) were done prospectively (rapidly within a week) for the contours and plans of every  RT patient, except for 2 late submissions. 4 clinicians reviewed the contours and physicists/dosimetrists reviewed the plans. Non-conformities (NCs), classed as major or minor (see Tables 1 and 2), were documented in standardised reports. Resubmissions were done for all plans with Major NC’s. Trial newsletters and centre visits were used to communicate common mistakes.


20 UK, 25 EORTC and 11 TROG centres submitted BM cases. BM resubmissions of contours and plans were: UK (1,0), EORTC (2,6) and TROG (1,3) respectively.

11 UK, 12 EORTC and 5 TROG centres treated patients with RT during the trial. RT patient numbers were UK (30), EORTC (26) and TROG (7). In total 25 (40%) patient cases needed resubmitting: 23 (37%) sets of outlines (2 cases twice) and 9 (14%) treatment plans (1 plan twice).

Tables 1 and 2 summarise the findings of the ICR’s.


Prospective review of all outlines and plans in a multinational clinical trial is achievable and ensures that all patients receive high quality RT. This is particularly important in a rare tumour where some centres submit less than 1 case per year and have little familiarity with the protocol.

The QA process was robust, ensuring a high level of consistency of RT treatment in the ROAM study (EORTC 1308).