Transcript Integrating Radiotherapy Trials QA into NCRI Clini

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
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
What is Radiotherapy?
http://www.oncoprof.net/Generale2000/g08
_Radiotherapie/gb08_rt06.html
http://cancerhelp.cancerresearchuk.org/type/wombcancer/treatment/radiotherapy/external-radiotherapy-for-womb-cancer
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
Outlining
Creating GTV and
PTV
Organs at Risk
Creating the plan
The plan
Dose to organs at risk and tumour
Dose Volume Histograms
SCOPE 1 Trial Design
Study of Chemoradiotherapy in Oesophageal Cancer plus of minus Erbitux
Stage 1
Patients with oesophageal
cancer chosen to receive
definitive CRT
Stage 2
CRT
Randomise
CRT +
cetuximab
Treatment
failure rate
Overall
survival
n=180
n=240
(total of 420)
Primary Endpoint
Stage 1
Treatment failure rate
(endoscopic assessment,
biopsy CT scan)
Stage 2
Overall survival
Secondary Endpoint
Toxicity
Feasibility
Toxicity
Quality Assurance - RT
Quality of Life
Health Economics
A7256
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
40Gy
No part
Liver
30Gy
60%
Right or Left Kidney
20Gy
25% (single kidney)
A7256
Why implement a QA RT programme?
• Share experience to help establish best practice
improve
• 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)
accuracy
• Ensure treatment accuracy (e.g. audit visit to verify RT plan
delivery)
Provide ongoing support to clinicians and planners for difficult cases
• Regular review of the protocol to incorporate new concepts of RT
support
delivery
•
Site Visit
• Equipment audit
• Dosimetry check
Pre-trial test case
Educational
• Assessment of
outlines
• Assessment of plan
• Assessment of form
completion
• RT specific protocol
with planning tips
• CD ROM with example
cases
Questionnaires
• Baseline
• Staff
• Trial specific
Assessment of patient
cases
QA RT
Process
• 1st case from each consultant
and 10% sample
• Plan Assessment Form for all
patients
• Check data is readable in
VODCA
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 (ontrial)
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
exported data
Examples of GTV
Consistency
Variation
Images exported from VODCA
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
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.
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
Thank You
Any Questions?