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Lisette Nixon

Integrating Radiotherapy Trials Quality Assurance (RTTQA) into National Cancer Research Institute (NCRI) clinical trials. Lisette Nixon. Co-ordinator Cardiff RTTQA group Velindre Cancer Centre 2. Senior Trial Manager Wales Cancer Trials Unit Cardiff University 1.

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Lisette Nixon

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  1. Integrating Radiotherapy Trials Quality Assurance (RTTQA) into National Cancer Research Institute (NCRI) clinical trials Lisette Nixon Co-ordinator Cardiff RTTQA group Velindre Cancer Centre 2 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, 6th Floor, Neuadd Meirionnydd, Heath Park, Cardiff CF14 4YS 2 Velindre Cancer Centre, Whitchurch, Cardiff, CF14 2TL

  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? http://cancerhelp.cancerresearchuk.org/type/womb-cancer/treatment/radiotherapy/external-radiotherapy-for-womb-cancer http://www.oncoprof.net/Generale2000/g08_Radiotherapie/gb08_rt06.html

  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 plannerapplies 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 Study of Chemoradiotherapyin Oesophageal Cancer plus of minus Erbitux Stage 1 Stage 2 Patients with oesophageal cancer chosen to receive definitive CRT Treatment failure rate Overall survival 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 A7256 CRT CRT + cetuximab

  12. SCOPE 1 Study of Chemotherapy in Oesophageal Cancer plus of minus Erbitux A7256

  13. Why implement a QA RT programme?

  14. QA process – who does what

  15. System check for the readability of exported data

  16. Examples of GTV Consistency Variation Images exported from VODCA

  17. Pros and Cons Pros 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 • 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

  18. 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.

  19. 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

  20. Thank YouAny Questions?

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