Presentation on theme: "Senior Trial Manager Wales Cancer Trials Unit Cardiff University 1"— Presentation transcript:
1Senior Trial Manager Wales Cancer Trials Unit Cardiff University 1 Integrating Radiotherapy Trials Quality Assurance (RTTQA) into National Cancer Research Institute (NCRI) clinical trialsLisette NixonSenior Trial ManagerWales Cancer Trials UnitCardiff University 1Co-ordinator Cardiff RTTQA groupVelindre Cancer Centre 2Lucy 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 11 Wales Cancer Trials Unit, Cardiff University, 6th Floor, Neuadd Meirionnydd, Heath Park, Cardiff CF14 4YS2 Velindre Cancer Centre, Whitchurch, Cardiff, CF14 2TLThank you for invite to speak.Mention been involved more than trial managers would be due to staffing problemsGreat 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.
2Who’ who Wales Cancer Trials Unit (WCTU) NCRI accredited Clinical Trials Unit who develop and run cancer clinical trialsNational Cancer Research InstituteUK-wide partnership between the government, charity and industry which promotes co-operation in cancer researchRadiotherapy Trials Quality Assurance Group (RTTQA)NCRI Group formed to provide central QA and advice for all RT trialsRTTQA CardiffSub-group of the main RTTQA groupVelindre NHS TrustNHS Trust within which the Cardiff RTTQA group sit and also sponsor for the SCOPE 1 trial
3What 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 acceleratorsThey comprise an electron source and an electromagnet which accelerates the electrons in a deep vacuum tube
4Planning of Radiotherapy Patient has a planning CT scan in treatment positionClinician 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
11Patients with oesophageal cancer chosen to receive definitive CRT SCOPE 1 Trial DesignStudy of Chemoradiotherapy in Oesophageal Cancer plus of minus ErbituxStage 1Stage 2CRTCRT + cetuximabTreatmentfailure rateOverallsurvivalPatients with oesophageal cancer chosen to receive definitive CRTRandomisen=180n=240(total of 420)Stage 2Overall survivalToxicityQuality Assurance - RT Quality of LifeHealth EconomicsStage 1Treatment failure rate(endoscopic assessment, biopsy CT scan)ToxicityFeasibilityPrimary EndpointSecondary EndpointA randomised phase II/III multi-centre clinical trial of definitive chemo-radiation, with or without Cetuximab, in carcinoma of the oesophagusObjective: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
12Maximum percentage of the OAR to receive max dose SCOPE 1Study of Chemotherapy in Oesophageal Cancer plus of minus ErbituxPTV Dose CoverageTarget DoseVolume of PTV receiving 95% of dose>99% of PTV to get 95% of doseMinimum dose to PTVMinimum dose to PTV should be greater than 93%Maximum dose to PTVShould be less than107%Organ at RiskMaximum DoseMaximum percentage of the OAR to receive max doseCombined Lungs20Gy25%Heart40Gy30%Spinal cord PRVNo partLiver30Gy60%Right or Left Kidney25% (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
13Why implement a QA RT programme? improveShare experience to help establish best practiceaccuracyEnsure 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)supportProvide ongoing support to clinicians and planners for difficult casesRegular review of the protocol to incorporate new concepts of RT deliveryThe 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.
14QA RT Process Site Visit Pre-trial test case Educational QuestionnairesBaselineStaffTrial specificEducationalRT specific protocol with planning tipsCD ROM with example casesSite VisitEquipment auditDosimetry checkPre-trial test caseAssessment of outlinesAssessment of planAssessment of form completionAssessment of patient cases1st case from each consultant and 10% samplePlan Assessment Form for all patientsCheck data is readable in VODCAThere 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
15QA process – who does what SiteWCTUVelindre (CI / MP)Completes pre-trial educational exercise and test caseTrials office chase up test cases, patient PAFs and plan dataPre-trial MP checks test case plan, drafts report including feedback on possible areas of improvement/adviceCompletes 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 WCTUPlans 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 casesSends data(ftp server / CD) to trials officePatient data where deviation appears on PAF, full plan is sent to MP for assessment (on-trial)On-trial investigates deviations
16System check for the readability of exported data
17Examples of GTVConsistencyVariationImages exported from VODCA
18Pros and Cons Pros Cons Ensures the quality of data Provides data on consistency of dose and treatmentAssesses adherence to protocolEducational component ensures minimum standard of treatment planningHelps improve networking and relationship with sitesPre-trial can take time complete and lengthen set up timesMay put centres off taking partCan be time consuming chasing up dataAdditional resources needed to evaluate plans
19Conclusions – SCOPE 160 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 centresThe 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.
20ConclusionsThe RTTQA group should be involved in all NIHR trials involving RadiotherapyIncluding a RTQA programme into a clinical trial should:provide consistency in RT treatment,raise the standards and consistency of RTgive validity to the resultsCollaborative 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
21Thank You Any Questions? Thank you for listening and any questions.