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Lisette Nixon Senior Trial Manager Wales Cancer Trials Unit Cardiff University 1 Lucy Wills 2, Emiliano Spezi 2, Sarah Gwynne 2, Rhydian Maggs 2, Tony.

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Presentation on theme: "Lisette Nixon Senior Trial Manager Wales Cancer Trials Unit Cardiff University 1 Lucy Wills 2, Emiliano Spezi 2, Sarah Gwynne 2, Rhydian Maggs 2, Tony."— Presentation transcript:

1 Lisette Nixon Senior Trial Manager Wales Cancer Trials Unit Cardiff University 1 Lucy Wills 2, Emiliano Spezi 2, Sarah Gwynne 2, Rhydian Maggs 2, Tony Millin 2, Chris Hurt 1, Geraint Lewis 2, John Staffurth 2, Gareth Griffiths 1 1 Wales Cancer Trials Unit, Cardiff University, 6 th Floor, Neuadd Meirionnydd, Heath Park, Cardiff CF14 4YS 2 Velindre Cancer Centre, Whitchurch, Cardiff, CF14 2TL Integrating Radiotherapy Trials Quality Assurance (RTTQA) into National Cancer Research Institute (NCRI) clinical trials Co-ordinator Cardiff RTTQA group Velindre Cancer Centre 2

2 Who who Wales Cancer Trials Unit (WCTU) –NCRI accredited Clinical Trials Unit who develop and run cancer clinical trials National Cancer Research Institute –UK-wide partnership between the government, charity and industry which promotes co-operation in cancer research Radiotherapy Trials Quality Assurance Group (RTTQA) –NCRI Group formed to provide central QA and advice for all RT trials RTTQA Cardiff –Sub-group of the main RTTQA group Velindre NHS Trust –NHS Trust within which the Cardiff RTTQA group sit and also sponsor for the SCOPE 1 trial

3 What is Radiotherapy? _Radiotherapie/gb08_rt06.html cancer/treatment/radiotherapy/external-radiotherapy-for-womb-cancer

4 Planning of Radiotherapy Patient has a planning CT scan in treatment position Clinician uses diagnostic information to draw round the tumour (GTV: Gross Tumour Volume) Clinician or planner applies margins to allow for set up errors and movement of patient (PTV: Planning Treatment Volume) Clinician or planner draws around other organs in proximity to the tumour (organs at risk) Planner optimises beams and arrangement of wedges/MLCs to get optimal coverage of PTV (i.e. all the area inside PTV received as close to the prescribed dose as possible) and minimises dose to organs at risk

5 Outlining Creating GTV and PTV

6 Organs at Risk

7 Creating the plan

8 The plan

9 Dose to organs at risk and tumour

10 Dose Volume Histograms

11 SCOPE 1 Trial Design Patients with oesophageal cancer chosen to receive definitive CRT Randomise CRT CRT + cetuximab Treatment failure rate Overall survival (total of 420) n=180n=240 Primary Endpoint Secondary Endpoint Stage 1Stage 2 Stage 1 Treatment failure rate (endoscopic assessment, biopsy CT scan) Toxicity Feasibility Stage 2 Overall survival Toxicity Quality Assurance - RT Quality of Life Health Economics Study of Chemoradiotherapy in Oesophageal Cancer plus of minus Erbitux A7256

12 PTV Dose CoverageTarget Dose Volume of PTV receiving 95% of dose>99% of PTV to get 95% of dose Minimum dose to PTV Minimum dose to PTV should be greater than 93% Maximum dose to PTVShould be less than107% Organ at RiskMaximum Dose Maximum percentage of the OAR to receive max dose Combined Lungs20Gy25% Heart40Gy30% Spinal cord PRV40GyNo part Liver30Gy60% Right or Left Kidney20Gy25% (single kidney) SCOPE 1 Study of Chemotherapy in Oesophageal Cancer plus of minus Erbitux A7256

13 Why implement a QA RT programme? improve Share experience to help establish best practice accuracy Ensure consistent approach across all centres with a pre-trial test case (e.g. clinical outlines, planning techniques) Ensure protocol adherence with on-trial QA (e.g. use of contrast, position verification) Ensure treatment accuracy (e.g. audit visit to verify RT plan delivery) support Provide ongoing support to clinicians and planners for difficult cases Regular review of the protocol to incorporate new concepts of RT delivery

14 QA RT Process Questionnaires Baseline Staff Trial specific Educational RT specific protocol with planning tips CD ROM with example cases Site Visit Equipment audit Dosimetry check Pre-trial test case Assessment of outlines Assessment of plan Assessment of form completion Assessment of patient cases 1 st case from each consultant and 10% sample Plan Assessment Form for all patients Check data is readable in VODCA

15 QA process – who does what SiteWCTUVelindre (CI / MP) Completes pre-trial educational exercise and test case Trials office chase up test cases, patient PAFs and plan data Pre-trial MP checks test case plan, drafts report including feedback on possible areas of improvement/advice Completes Plan Assessment Form (pre and on-trial) TM performs system check for readability of data (pre- and on-trial) On- trial advice where requested by WCTU Plans patient and exports DICOM data (pre- and on-trial) Checks PAF and highlights any out of range values (on- trial) On- trial assessment of patient cases Sends data(ftp server / CD) to trials office Patient data where deviation appears on PAF, full plan is sent to MP for assessment (on-trial) On-trial investigates deviations

16 System check for the readability of exported data

17 Examples of GTV Variation Consistency Images exported from VODCA

18 Pros and Cons Pros Ensures the quality of data Provides data on consistency of dose and treatment Assesses adherence to protocol Educational component ensures minimum standard of treatment planning Helps improve networking and relationship with sites Cons Pre-trial can take time complete and lengthen set up times May put centres off taking part Can be time consuming chasing up data Additional resources needed to evaluate plans

19 Conclusions – SCOPE 1 60 test case outlines and 40 plans have been returned, which means that the SCOPE 1 protocol and RT guidance document has been read and followed in all these centres The data collected suggest this has been a good educational exercise and highlights that there are variations between centres which can be addressed to improve consistency between both consultants and centres. A comprehensive QA programme can be implemented within a clinical trials unit with good collaboration and medical physics support.

20 Conclusions The RTTQA group should be involved in all NIHR trials involving Radiotherapy Including a RTQA programme into a clinical trial should: –provide consistency in RT treatment, –raise the standards and consistency of RT –give validity to the results Collaborative working between WCTU and the Cardiff RTTQA group has provided a set of standards to use for subsequent trials and has proved to be a successful model

21 Thank You Any Questions?

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