Quality assurance of the SCOPE 1 trial in oesophageal radiotherapy.

BACKGROUND: SCOPE 1 was the first UK based multi-centre trial involving radiotherapy of the oesophagus. A comprehensive radiotherapy trials quality assurance programme was launched with two main aims: 1. To assist centres, where needed, to adapt their radiotherapy techniques in order to achieve protocol compliance and thereby enable their participation in the trial. 2. To support the trial's clinical outcomes by ensuring the consistent planning and delivery of radiotherapy across all participating centres. METHODS: A detailed information package was provided and centres were required to complete a benchmark case in which the delineated target volumes and organs at risk, dose distribution and completion of a plan assessment form were assessed prior to recruiting patients into the trial. Upon recruiting, the quality assurance (QA) programme continued to monitor the outlining and planning of radiotherapy treatments. Completion of a questionnaire was requested in order to gather information about each centre's equipment and techniques relating to their trial participation and to assess the impact of the trial nationally on standard practice for radiotherapy of the oesophagus. During the trial, advice was available for individual planning issues, and was circulated amongst the SCOPE 1 community in response to common areas of concern using bulletins. RESULTS: 36 centres were supported through QA processes to enable their participation in SCOPE1. We discuss the issues which have arisen throughout this process and present details of the benchmark case solutions, centre questionnaires and on-trial protocol compliance. The range of submitted benchmark case GTV volumes was 29.8-67.8cm3; and PTV volumes 221.9-513.3 cm3. For the dose distributions associated with these volumes, the percentage volume of the lungs receiving 20Gy (V20Gy) ranged from 20.4 to 33.5%. Similarly, heart V40Gy ranged from 16.1 to 33.0%. Incidence of incorrect outlining of OAR volumes increased from 50% of centres at benchmark case, to 64% on trial. Sixty-five percent of centres, who returned the trial questionnaire, stated that their standard practice had changed as a result of their participation in the SCOPE1 trial. CONCLUSIONS: The SCOPE 1 QA programme outcomes lend support to the trial's clinical conclusions. The range of patient planning outcomes for the benchmark case indicated, at the outset of the trial, the significant degree of variation present in UK oesophageal radiotherapy planning outcomes, despite the presence of a protocol. This supports the case for increasingly detailed definition of practice by means of consensus protocols, training and peer review. The incidence of minor inconsistencies of technique highlights the potential for improved QA systems and the need for sufficient resource for this to be addressed within future trials. As indicated in questionnaire responses, the QA exercise as a whole has contributed to greater consistency of oesophageal radiotherapy in the UK via the adoption into standard practice of elements of the protocol. TRIAL REGISTRATION: The SCOPE1 trial is an International Standard Randomized Controlled Trial, ISRCTN47718479 .

Toward semi-automated assessment of target volume delineation in radiotherapy trials: the SCOPE 1 pretrial test case.

PURPOSE: To evaluate different conformity indices (CIs) for use in the analysis of outlining consistency within the pretrial quality assurance (Radiotherapy Trials Quality Assurance [RTTQA]) program of a multicenter chemoradiation trial of esophageal cancer and to make recommendations for their use in future trials. METHODS AND MATERIALS: The National Cancer Research Institute SCOPE 1 trial is an ongoing Cancer Research UK-funded phase II/III randomized controlled trial of chemoradiation with capecitabine and cisplatin with or without cetuximab for esophageal cancer. The pretrial RTTQA program included a detailed radiotherapy protocol, an educational package, and a single mid-esophageal tumor test case that were sent to each investigator to outline. Investigator gross tumor volumes (GTVs) were received from 50 investigators in 34 UK centers, and CERR (Computational Environment for Radiotherapy Research) was used to perform an assessment of each investigator GTV against a predefined gold-standard GTV using different CIs. A new metric, the local conformity index (l-CI), that can localize areas of maximal discordance was developed. RESULTS: The median Jaccard conformity index (JCI) was 0.69 (interquartile range, 0.62-0.70), with 14 of 50 investigators (28%) achieving a JCI of 0.7 or greater. The median geographical miss index was 0.09 (interquartile range, 0.06-0.16), and the mean discordance index was 0.27 (95% confidence interval, 0.25-0.30). The l-CI was highest in the middle section of the volume, where the tumor was bulky and more easily definable, and identified 4 slices where fewer than 20% of investigators achieved an l-CI of 0.7 or greater. CONCLUSIONS: The available CIs analyze different aspects of a gold standard-observer variation, with JCI being the most useful as a single metric. Additional information is provided by the l-CI and can focus the efforts of the RTTQA team in these areas, possibly leading to semi-automated outlining assessment.

The effect of planning algorithms in oesophageal radiotherapy in the context of the SCOPE 1 trial.

BACKGROUND AND PURPOSE: In radiotherapy clinical trials multiple centres contribute to patient recruitment. Depending on the calculation algorithm used, the reported dose distributions may differ significantly: broadly, the results for algorithms which do not model lateral electron transport (type a) give less accurate results than the more recently available algorithms that do (type b) when compared to Monte Carlo simulations and measurements. Clinical implementation studies for type b algorithms have yet to be reported for oesophageal radiotherapy. Furthermore, clinical trials must ensure an equivalent effect of the treatment regardless of calculation method. This retrospective planning study aims to define guidance for type b planning in a UK oesophageal clinical trial, to enable acceptable consistency of dose distributions regardless of algorithm, and allow for the improved calculation accuracy of type b to be incorporated into the optimization. MATERIALS AND METHODS: Fifteen patient data sets were planned using a single type a algorithm. Plans were recalculated using a single type b algorithm and subsequently re-optimized with the type b in accordance with optimization rules. The changes in absolute dose at the point of prescription for type a were compared to the recalculated type b. Dose-volume data for organs at risk (OARs), and target volumes were compared, and the volume of the planning target volume (PTV) receiving 95% of the prescribed dose (V95%) was compared to the percentage of PTV overlapping with lung. RESULTS: Dose at the prescription point decreased by 0.69% on average (SD=0.71), p=0.0021, for type b compared to that for type a. For the re-optimized type b, the OAR doses corresponding to the trial dose-volume constraints were maintained within 1.0% of the type a levels on average. Reductions in the mean PTV V95% of 9.3% and 3.8% were observed for the recalculated and re-optimized type b plans, respectively, when compared to the mean PTV V95% for type a. For the re-optimized type b there is a correlation between PTV V95% and the percentage of PTV overlapping lung (R(2)=0.4979). CONCLUSIONS: Plan optimization with the type b algorithm results in improved PTV V95%. Using our suggested optimization rules, equivalent OAR doses can be maintained with both types. For type b, this requires a measured level of compromise to PTV in low density tissue, quantified by the relationship between PTV V95% and the percentage of PTV in lung.