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Senior Trial Manager Wales Cancer Trials Unit Cardiff University 1

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Presentation on theme: "Senior Trial Manager Wales Cancer Trials Unit Cardiff University 1"— Presentation transcript:

1 Senior Trial Manager Wales Cancer Trials Unit Cardiff University 1
Integrating Radiotherapy Trials Quality Assurance (RTTQA) into National Cancer Research Institute (NCRI) clinical trials Lisette Nixon Senior Trial Manager Wales Cancer Trials Unit Cardiff University 1 Co-ordinator Cardiff RTTQA group Velindre Cancer Centre 2 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, 6th Floor, Neuadd Meirionnydd, Heath Park, Cardiff CF14 4YS 2 Velindre Cancer Centre, Whitchurch, Cardiff, CF14 2TL Thank you for invite to speak. Mention been involved more than trial managers would be due to staffing problems Great support from RTTQA group and the QA RT has been run from the coordinating centre rather than from within a MP department, and outside MVH or RMH.

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? With an 18 MeV accelerator, it is possible to irradiate up to 15cm deep tumours with little irradiation of healthy tissue situated on the beam path For a zone situated at a depth of 15cm, approximately 70% of the dose is delivered to the tumour. When using four field treatment, less than 50% of the dose is delivered to the neighbouring healthy tissue. Linear accelerators They comprise an electron source and an electromagnet which accelerates the electrons in a deep vacuum tube

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 Add picture of all beams

9 Dose to organs at risk and tumour

10 Dose Volume Histograms
Green – PTV Pink – Heart Red – lung Cyan - SC PTV Gold - liver

11 Patients with oesophageal cancer chosen to receive definitive CRT
SCOPE 1 Trial Design Study of Chemoradiotherapy in Oesophageal Cancer plus of minus Erbitux Stage 1 Stage 2 CRT CRT + cetuximab Treatment failure rate Overall survival Patients with oesophageal cancer chosen to receive definitive CRT Randomise n=180 n=240 (total of 420) Stage 2 Overall survival Toxicity Quality Assurance - RT Quality of Life Health Economics Stage 1 Treatment failure rate (endoscopic assessment, biopsy CT scan) Toxicity Feasibility Primary Endpoint Secondary Endpoint A randomised phase II/III multi-centre clinical trial of definitive chemo-radiation, with or without Cetuximab, in carcinoma of the oesophagus Objective: To determine whether the addition of cetuximab to definitive chemoradiation (CRT) shows increased survival in the treatment of patients with non-metastatic carcinoma of the oesophagus. Previous trials in oesophageal cancer have shown that CRT gives the best survival in patients not suitable for surgery. We hope to improve this by the addition of cetuximab. The trial design means that the data will be analyzed by an IDMC after 180 patients to establish activity and safety of the addition of cetuximab. Centres will not be aware of this transition from a phase II to III. A7256

12 Maximum percentage of the OAR to receive max dose
SCOPE 1 Study of Chemotherapy in Oesophageal Cancer plus of minus Erbitux PTV Dose Coverage Target 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 PTV Should be less than107% Organ at Risk Maximum Dose Maximum percentage of the OAR to receive max dose Combined Lungs 20Gy 25% Heart 40Gy 30% Spinal cord PRV No part Liver 30Gy 60% Right or Left Kidney 25% (single kidney) The protocol gives limits on the doses including the coverage of the PTV and dose to organs at risk. We have pre-defined minor and major deviations which means that deviations from the protocol can quickly and consistently be assessed as to how serious they are. 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 The key message from good clinical practice is that the patient comes first. If the standard is consistent across the UK, especially if this means the standard has been improved in some centres, then this has to be good for patients. For the trial it is important, when comparing 2 arms, that there is consistency and accuracy across common treatments in both arms. Dose of RT should be considered as important as dose of CT. The protocol was written using the best available information at the time. There is the possibility that research shows certain aspects need to be updated in the future.

14 QA RT Process Site Visit Pre-trial test case Educational
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 1st case from each consultant and 10% sample Plan Assessment Form for all patients Check data is readable in VODCA There are a number of aspects to the QA process such as questionnaires, educational component, site visit, pre-trial test case and on trial assessment of patient cases. Emphasis pre- trial and on-trial and explain differences

15 QA process – who does what
Site WCTU Velindre (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 Consistency Variation Images exported from VODCA

18 Pros and Cons Pros Cons 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 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?
Thank you for listening and any questions.

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