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.

Lisette NixonLisette 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, 6th 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

Who’ whoWho’ whoWales 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

What is Radiotherapy?What is Radiotherapy?

http://www.oncoprof.net/Generale2000/g08_Radiotherapie/gb08_rt06.html

http://cancerhelp.cancerresearchuk.org/type/womb-cancer/treatment/radiotherapy/external-radiotherapy-for-womb-cancer

Planning of RadiotherapyPlanning 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

OutliningOutlining

Creating GTV and PTV

Organs at Risk

Creating the planCreating the plan

The planThe plan

Dose to organs at risk and tumourDose to organs at risk and tumour

Dose Volume HistogramsDose Volume Histograms

SCOPE 1 Trial DesignSCOPE 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=180 n=240

Primary Endpoint

Secondary Endpoint

Stage 1 Stage 2

Stage 1 Treatment failure rate(endoscopic assessment, biopsy CT scan)

ToxicityFeasibility

Stage 2 Overall survival

ToxicityQuality Assurance - RT Quality of LifeHealth Economics

Study of Chemoradiotherapy in Oesophageal Cancer plus of minus Erbitux

A7256

PTV Dose Coverage Target Dose

Volume of PTV receiving 95% of dose >99% of PTV to get 95% of dose

Minimum dose to PTVMinimum 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 40Gy No part

Liver 30Gy 60%

Right or Left Kidney 20Gy 25% (single kidney)

SCOPE 1SCOPE 1Study of Chemotherapy in Oesophageal Cancer plus of minus Erbitux

A7256

Why implement a QA RT programme?Why implement a QA RT programme?

QA process – who does whatQA 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

System check for the readability of System check for the readability of exported dataexported data

Examples of GTVExamples of GTV

Variation

Consistency

Images exported from VODCA

Pros and ConsPros and ConsPros

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

Conclusions – SCOPE 1Conclusions – 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.

ConclusionsConclusions

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

Thank YouThank You

Any Questions?Any Questions?