International Journal of

Radiation Oncology

biology physics

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Physics Contribution

Global Harmonization of Quality AssuranceNaming Conventions in Radiation TherapyClinical TrialsChristos Melidis, MSc,* Walther R. Bosch, DSc,y

Joanna Izewska, PhD,z Elena Fidarova, MD,x Eduardo Zubizarreta, MD,x

Kenneth Ulin, PhD,jj Satoshi Ishikura, MD,{

David Followill, Medical Physicist (Prof),#

James Galvin, Medical Physicist (PhD),**Annette Haworth, Medical Physicist (Prof),yy Deidre Besuijen, MSc,zz

Clark H. Clark, PhD,xx Elizabeth Miles, MSc,jjjj Edwin Aird, PhD,jjjj

Damien C. Weber,{{ Coen W. Hurkmans, PhD,## andDirk Verellen, Medical Physicist (Prof)***

*European Organization for the Research and Treatment of CancereRadiation Oncology Group(EORTC-ROG), Radiation Therapy Quality Assurance (RTQA), Brussels, Belgium; yWashingtonUniversity, representing Advanced Technology Consortium, Radiation Oncology, St. Louis, Missouri;zDosimetry Laboratory and xApplied Radiation Biology and Radiotherapy Section, InternationalAtomic Energy Agency, Vienna, Austria; jjDepartment of Radiation Oncology, University ofMassachusetts Medical School, Representing Quality Assurance Review Center, Worcester,Massachusetts; {Department of Radiation Oncology, Juntendo University, Representing JapanClinical Oncology Group, RTQA, Tokyo, Japan; #Department of Radiation Physics, The University ofTexas MD Anderson Cancer Center, Representing Radiological Physics Center, RTQA, Houston, Texas;**Department of Radiation Oncology, Thomas Jefferson University, Representing Radiation TherapyOncology Group, RTQA, Philadelphia, Pennsylvania; yyDepartment of Physical Sciences, PeterMacCallum Cancer Centre, Melbourne, representing TransTasman Radiation Oncology Group (TROG)Cancer Research, Newcastle, Australia; zzNorth West Cancer Centre, Representing TROG CancerResearch, Newcastle, Australia; xxDepartment of Medical Physics, St. Luke’s Cancer Centre, Royal

Reprint requests to: Christos Melidis, MSc, European Organization for

Research and Treatment of Cancer, Ave E. Mounier 83, 1200 Brussels,

Belgium. Tel: (þ32) 27-74-15 07; E-mail: christos.melidis@eortc.be

This publication was supported by Fonds Cancer, Belgium.

The steering committee members of the Global Clinical Trials RTQA

Harmonization Group in May 2014 are as follows. International: The In-

ternational Atomic Energy Agency; North America: Imaging and Radia-

tion Oncology Core, National Cancer Institute of Canada Clinical Trials

Group, and Radiation Therapy Oncology Group; Europe: European Or-

ganization for the Research and Treatment of CancereRadiation Oncology

Group, Radiotherapy Trials Quality Assurance; Asia: Japan Clinical

Oncology Group; Australia: TransTasman Radiation Oncology Group.

Conflict of interest: none.

AcknowledgmentsdThe authors would like to thank other active

participants in the formation of the Global Clinical Trials RTQA

Harmonization Group not listed as authors above: Australia: Tomas

Kron, Martin Ebert, and Joan Hatton; Belgium: Akos Gulyban; Canada:

Coreen Corning; Switzerland: Stefano Gianolini; United States: Jeff

Michalski, Geoff Ibbott, Vikram Bhadrasain, Andrea Molineau, William

Straube, and Ying Xiao.

Int J Radiation Oncol Biol Phys, Vol. 90, No. 5, pp. 1242e1249, 20140360-3016/$ - see front matter � 2014 Elsevier Inc. All rights reserved.

http://dx.doi.org/10.1016/j.ijrobp.2014.08.348

Volume 90 � Number 5 � 2014 Harmonization of RTQA naming conventions 1243

Surrey County Hospital, Guildford, Surrey and National Physical Laboratory, Teddington, Middlesex,representing Radiation Therapy Trials Quality Assurance (RTTQA), United Kingdom; jjjjMount VernonCancer Centre, Northwood, Middlesex representing RTTQA, United Kingdom; {{Center for ProtonTherapy, Paul Scherrer Institute, Villigen, Switzerland, Representing the EORTC-ROG, RTQA, Brussels,Belgium; ##Catharina Hospital, Eindhoven, The Netherlands, Representing EORTC-ROG, RTQA,Brussels, Belgium; and ***Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels,Belgium

Received Jun 17, 2014, and in revised form Aug 5, 2014. Accepted for publication Aug 28, 2014.

Summary

Various radiation therapyquality assurance (RTQA)procedures and naming con-ventions are used by clinicaltrial groups worldwide. TheGlobal Harmonisation Grouphere presents an overview ofthese procedures and namesand a new harmonizedRTQA naming conventionfor use in clinical trialsincorporating RT. This over-view, incorporating theharmonization of RTQAnaming conventions from 27to 10, will facilitate inter-group trial collaboration andsimplify exchange and inter-pretation of RTQA results.

Purpose: To review the various radiation therapy quality assurance (RTQA) proce-dures used by the Global Clinical Trials RTQA Harmonization Group (GHG) steeringcommittee members and present the harmonized RTQA naming conventions by amal-gamating procedures with similar objectives.Methods and Materials: A survey of the GHG steering committee members’ RTQAprocedures, their goals, and naming conventions was conducted. The RTQA proce-dures were classified as baseline, preaccrual, and prospective/retrospective data cap-ture and analysis. After all the procedures were accumulated and described,extensive discussions took place to come to harmonized RTQA procedures and names.Results: The RTQA procedures implemented within a trial by the GHG steering com-mittee members vary in quantity, timing, name, and compliance criteria. The proce-dures of each member are based on perceived chances of noncompliance, so thatthe quality of radiation therapy planning and treatment does not negatively influencethe trial measured outcomes. A comparison of these procedures demonstrated similar-ities among the goals of the various methods, but the naming given to each differed.After thorough discussions, the GHG steering committee members amalgamated the27 RTQA procedures to 10 harmonized ones with corresponding names:facility questionnaire, beam output audit, benchmark case, dummy run, complex treat-ment dosimetry check, virtual phantom, individual case review, review of patients’treatment records, and protocol compliance and dosimetry site visit.Conclusions: Harmonized RTQA harmonized naming conventions, which can be usedin all future clinical trials involving radiation therapy, have been established. Harmo-nized procedures will facilitate future intergroup trial collaboration and help to ensurecomparable RTQA between international trials, which enables meta-analyses and re-duces RTQA workload for intergroup studies. � 2014 Elsevier Inc.

Introduction

The Global Clinical Trials Quality Assurance of RadiationTherapy Harmonization Group (GHG) (1) includes repre-sentation from clinical trial quality assurance (QA) officesfrom around the world (www.RTQAHarmonisation.org).The GHG’s main objective is to harmonize and improve theradiation therapy (RT) QA within multi-institutional coop-erative clinical trials for the treatment of cancer (2). Thesteering committee members at present are detailed in thefirst-page footnote.

All organizations and cooperative groups participating inthe GHG ensure the quality of RT through their ownestablished QA procedures, with some originating morethan 40 years ago (3). Further information on the GHG canbe found at the group’s website.

There are some distinct variations within and betweeneach group’s RTQA procedures found in the literature

(4-6), and this often complicates intergroup trial coopera-tion. For some intergroup trials, the RTQA is performedthrough adaption to one of the participating groups’ RTQAprocedures, whereas in other trials each group follows itsown procedures. For example, within the EORTC 10853-Ductal Carcinoma In-Situ (DCIS) intergroup trial (7), theRTQA is centrally performed by EORTC-ROG using theirRTQA infrastructure. Similarly, the patient-specific RTQAof the new joint Radiation Therapy Oncology Group(RTOG) 0848-EORTC 40084 trial is performed throughinfrastructure made available by RTOG. On the other hand,the RTQA within the Supremo trial (8) is performed byseveral RTQA groups (RTTQA, EORTC, and TransTasmanRadiation Oncology Group [TROG]).

Although these examples show that intergroup trial coop-eration is already possible, the absence of harmonized pro-cedures made the initiation of RTQAwithin these trials morelabor intensive and complicated than needed. Additionally,

Melidis et al. International Journal of Radiation Oncology � Biology � Physics1244

coordination of RTQA activities, as well as RTQA dataanalysis and interpretation, is hampered by the lack ofharmonized procedures. Additionally, for sites recruiting to avariety of clinical trial groups, the investigator site often needsto perform similar tasks for each separate trial group.Furthermore, meta-analyses of RTQA clinical trial data arenow hindered by the large variety in RTQA procedures, whichrenders any meaningful intercomparison difficult.

The purpose of this study was to review the various defi-nitions and naming conventions of the RTQA procedures asdefined in the RT section (or separate RT Planning and De-livery Guideline document) of each trial protocol used byeach steering committee member’s organization within RTclinical trials. Given the observed similarities concerning thegoals of the various globally implemented RTQA procedureswithin the GHG, a new harmonized set of RTQA proceduresand corresponding naming conventions is presented.

Methods and Materials

A survey of the RTQA procedures of each GHG steeringcommittee member was conducted. The results are pre-sented in Table 1 and the definitions follow below.

Baseline

For a site to participate in a clinical trial with RT, it mustfirst become a participant within the QA program of a GHGmember. Baseline QA procedures ensure that sites can meetminimum established requirements for trial participation asrequired by the GHG member.

Facility and basic dosimetric requirements

Facility questionnaireThe facility questionnaire collects information about thesite’s contact personnel, workload, and RT and QA equip-ment and procedures. It ensures that minimum re-quirements established by the requesting GHG member (egthe maximum number of patients per specialist per year,available QA equipment) are met (9).

Beam output audit/external reference dosimetry audit/reference beam outputThis procedure is a verification of the dose delivery underreference conditions at the site. It is a dose measurementperformed by a national or international auditor, indepen-dent from the site, and must meet specific requirementsestablished by the requesting GHG member (10, 11). Var-iations exist among the GHG steering committee membersconcerning the measurement detector, geometry, frequency,number of beams, and RT machines to be evaluated.

Preaccrual

Trial-specific preaccrual procedures verify that sites canmeet any combination of the following before they begin to

accrue patients: export and upload a complete RT datasetinto the GHG member’s reviewing software, adhere to thestructure delineation and RT planning requirements of theprotocol, or plan and deliver a specified dose using anadvanced RT technique.

Protocol-compliant dummy patient or siteconnectivity check

Completing a test case is a common RTQA procedure.Quantifying the degree of variation from the protocol candetermine the level of “education” or interventionrequired before trial accrual begins. A major deviation is a“significant” variation from the protocol that may affectthe validity of interpretation of trial results, would this testcase be an actual trial patient, whereas minor deviationsmay require education to prevent major deviations inactual trial patients (12). As an example, the non-delineation or not-accurate delineation of an organ at risk(OAR) may be considered a minor deviation, whereas thesame observation on the margins between clinical andplanned target volume may be considered a majordeviation.

Benchmark case by Radiological Physics Center (RPC)and TROG/dry run by Image-guided Therapy QA Center(ATC-ITC)/dummy run by EORTC-ROG, Japan ClinicalOncology Group (JCOG), and RTOG/outlining andplanning cases/exercises by Radiation Therapy TrialsQuality Assurance (RTTQA)Sites are required to contour and/or plan on a common setof CT datasets (which provides an opportunity to quantifycontouring and planning variations between sites) accord-ing to the protocol and then successfully transmit the planelectronically to the GHG member. The procedure issometimes split into 2 steps: a delineation exercise on acommon set of CT datasets, and then a planning exercise onprecontoured CT datasets (13, 14). Any variation is givenas feedback to the site (with potential resubmission), so thatprotocol compliance will be improved during patientaccrual.

These procedures also test the clarity and feasibility ofthe RT instructions within the RT and RTQA section of aprotocol and the RTQA guidelines before patient accrualbegins and may lead to their further refinement.

Benchmark case by EORTC-ROG and International AtomicEnergy Agency (IAEA)/rapid review by RPC, RTOG, andATC-ITC/pretrial case review by RTTQA/dummy run byTROGSites are required to submit a protocol-compliant treat-ment plan on an in-house, nontrial patient with similartrial pathology. The dataset is checked for its integrity,delineation, and dose constraint compliance, and anyvariation is given as feedback to the site (with potentialresubmission), to improve protocol agreement during pa-tient accrual.

Table 1 RTQA procedures among the GHG steering committee members

Member

Baseline PreaccrualProspective/retrospective RTQA data

capture and analysis

Facility andbasic dosimetricrequirements

Protocol-compliantdummy patient

or siteconnectivity check

AdvancedRT techniquecredentialing

Remote reviewof patients’ RTtreatments

Sitevisits

ATC-ITC Not performed Data submissiontest or rapidreview or dry run

Not performed 1. Basic archiving2. 1 þ completeness

check3. 2 þ compute DVHs4. 3 þ reconcile

structures5. 4 þ image

registrationand case reportforms

Not performed

EORTC-ROG Facility questionnaireand external referencedosimetry audit byRPC or other QAoffice

Dummy run ordigital data integrityquality assurance

Complex dosimetrycheck or virtualphantomprocedure

Individual case reviewand case report forms

Notperformed

IAEA Facility questionnaire andreference beam output

Benchmark cases Complex dosimetrycheck

Individual case reviewand case report forms

Notperformed

JCOG Facility questionnaire andexternal referencedosimetry audit

Dummy run or digitaldata integrityquality assurance

Complex dosimetrycheck

Individual case reviewand case report forms

Notperformed

RPC Facility questionnaireand OSLD/TLDbeam output audit

Benchmark casesor rapid review

Credentialing foradvanced technologyclinical trials orcomplex dosimetrycheck

Review of patients’treatment records,timely reviews,and case reportforms

On-sitedosimetryreviewvisits

RTOG Facility questionnaireand external referencedosimetry audit by RPC

Dummy run orrapid reviewor dry run

Credentialing foradvancedtechnologyclinical trials

Individual case reviewand case reportforms

On-sitedosimetryreviewvisitsby RPC

RTTQA Facility questionnaireand external referencedosimetry audit byRTTQA or IPEM/NPL*

Outlining andplanningcases/exercisesor pretrialcase review

Credentialingfor advancedtechniques

Individual case reviewand case reportforms/planassessment form

On-sitedosimetryvisit

TROG Facility questionnaireand external referencedosimetry audit (eg,ARPANSA/ACDS)

Benchmark casesor dummy runor digital dataintegrity qualityassurance

Credentialing foradvancedtechnologyclinical trials

Individual case reviewand case reportforms

On-sitedosimetryreviewvisits byTROG(or approvedservice)

Abbreviations: ATC Z Advanced Technology Consortium; ARPANSA/ACDS Z Australian Radiation Protection and Nuclear Safety Agency/

Australian Clinical Dosimetry Service; EORTC-ROG Z European Organization for the Research and Treatment of CancereRadiation Oncology Group;

GHG Z Global Clinical Trials RTQA Harmonization Group; IAEA Z International Atomic Energy Agency; IPEM/NPL Z Institute of Physics and

Engineering in Medicine/National Physical Laboratory; ITCZ Image-guided Therapy QA Center; JCOG Z Japan Clinical Oncology Group; OSLD/

TLD Z optically stimulated/thermoluminescent dosimeter; RPC Z Radiological Physics Center; RTOG Z Radiation Therapy Oncology Group;

RTQA Z Radiation Therapy Quality Assurance; RTTQA Z Radiation Therapy Trials Quality Assurance; TROG Z TransTasman Radiation Oncology

Group.

Volume 90 � Number 5 � 2014 Harmonization of RTQA naming conventions 1245

Data submission test by ATC-ITC/dry run by RTOG/digital data integrity quality assurance by EORTC-ROG,JCOG, and TROGA site is required to upload an in-house patient’s RTdataset that was planned using the same treatment tech-nique and equipment to be used for patients within the

trial, including complete datasets from any imagingmodalities and/or cone-beam CT. The dataset is checkedfor its integrity and anonymity of patient details, veri-fying that a site can export and upload the requireddatasets, so that prospective reviews meet protocol timeframes.

Melidis et al. International Journal of Radiation Oncology � Biology � Physics1246

Advanced RT technique credentialing

The purpose of this credentialing is to increase thelikelihood that sites have the “necessary expertise andresources” to safely implement new irradiation tech-niques, such as intensity modulated RT, volumetricmodulated arc therapy, and Tomotherapy, in the contextof a clinical trial (15). Currently there exist variationsamong the GHG members concerning the appropriatedetectors, acceptable dose limits, frequency, and auditingbodies (3, 16).

Complex dosimetry check (CDC)This end-to-end test uses a mailed phantom for planningCT acquisition, treatment planning, and dose deliveryverification. The absolute doses between calculation andmeasurement must agree within predefined limits as set bythe GHG member, and the dose is measured in at least 1plane. The dosimeters are provided by the auditing orga-nization and may include, for example, ion chambers, films,thermoluminescent dosimeters (TLDs), and opticallystimulated luminescence dosimeters (OSLDs)/TLDs.

Credentialing for advanced techniques by RTTQA andTROGThis credentialing includes questionnaires and a processdocument (description and examples of all relevant pro-cedures in recruiting site), verification of electronic transferof data, outlining exercises, planning exercises, and dosepoint and distribution measurements on phantoms for bothstandard and clinical trial plans (16-20). This procedure isaccomplished during site visits.

Credentialing for advanced technology clinical trials byRPC and RTOGThis procedure is accomplished either via a benchmarktreatment plan or simulation, planning, and irradiation of ananthropomorphic phantom and includes the components ofCDC, with the addition of questionnaires, a dosimetry re-view, and a review of the site’s QA, dosimetry proceduresand records.

Virtual phantomSites use a provided CT dataset to plan a treatment ac-cording to specific guidelines. The plan is recalculated onthe sites’ own QA phantom geometry, and the phantom isirradiated according to plan, avoiding the necessity of aphantom to be mailed to the site. The dataset and therequired measurement files are uploaded to the EORTC forevaluation (21).

Prospective/retrospective RTQA data capture andanalysis

These procedures assure that the protocol requirements arebeing or have been followed for on-trial patients by

reviewing a combination of diagnostic images and RTtarget volume and OAR structure sets and treatment plansor conducting site visits. Here again a major deviation is thesame as under “Protocol-compliant dummy patient” (12).

Remote review of patients’ RT treatments

Timely review by RPC/individual case review by EORTC-ROG, IAEA, JCOG, RTOG, RTTQA, and TROG/imageregistration by ITCTimely review consists of review of the actual delineationand treatment plan of trial patients, including diagnosticimages if applicable, to assess target volumes and OARs orrepositioning. Where image-guided RT is used, organ mo-tion and treatment response images may also be collected.This procedure assures protocol compliance of trial patientsand can be done prospectively (22) or retrospectively(5, 23-25). Prospective review provides an opportunity forprotocol compliance feedback to the site, such that delin-eation and planning changes can be made before the patientbegins treatment. Prospective feedback reduces protocoldeviations, creating stronger statistical significance for theresults of the trial (22). Retrospective reviews that are fedback to the site during trial accrual may also have a positiveimpact on protocol compliance, but only for subsequentpatients.

When referring to the image registration procedure byITC, it presupposes the previous use of “Basic Archiving,”“Completeness Check,” “Compute DoseeVolume Histo-grams,” and “Reconcile Structures.” Table 1 presents theselast 4 procedures under ITC only: (1) Basic Archiving:Storing of patients’ RT datasets for possible future evalu-ation; (2) Completeness Check: Identical to data submis-sion test but using trial patient datasets instead of “dummypatients”; (3) Compute DoseeVolume Histograms: A dose-only constraints protocol compliance check; (4) ReconcileStructures: A target volume and OAR delineation and doseconstraints protocol compliance check.

Review of patient’s treatment record by RPCTreatment plans are reviewed retrospectively to ensure thatthey have met the dosimetric and delineation requirementsof the protocol. Measurements made at the site through theOSLD/TLD Beam Output Audit program and on-sitedosimetry review visits (see below) are used, combinedwith the treatment parameters provided by the site (eg fieldsize, depth, monitor unit [MU] setting), to independentlyverify the dose received by the patient.

Case report forms/plan assessment formSites retrospectively send paper or electronic reports con-cerning theRT treatment for all trial patients. The questions arepredefined and usually include details of prescribed anddelivered irradiations, as well as volume sizes and dose dis-tribution to them. Although some of this information can beextracted from the review of the RT plan, this only representswhat was planned for the patient. Efforts are already being

Volume 90 � Number 5 � 2014 Harmonization of RTQA naming conventions 1247

conducted by theNational Cancer Institute of theUnited Statestowards the global harmonization of case report forms (26).

Site visits

On-site dosimetry visit by RTTQAThis is a visit that ensures consistency between predictedand measured dose and includes measurements of output inreference conditions, as well as credentialing for advancedtechniques using a protocol-compliant plan on a phantom.

On-site dosimetry review visit by TROGA trial QA representative reviews the trial protocol withpersonnel from the site and observes the entire treatmentprocess for a trial patient to confirm that the institution hasproperly implemented the protocol and to check for anyprotocol ambiguities. The procedure also includes mea-surements of output in reference conditions, as well as dosepoints and dose distributions using phantoms.

On-site dosimetry review visit by RPCThis consists of a review of the site’s treatment planningdosimetry data used to calculate beam-on time for each trialpatient, the QA procedures and documentation, a review oftreatment records to ascertain the consistency of the pro-cedures used for treatment planning and MU calculations,and also includes dosimetry measurements.

Results

The RTQA required within a clinical trial is based on theRT section of each trial protocol. Because RTQA’s missionis to ensure RT protocol compliance of all participatingsites, the RT section must be comprehensive, be clear, andidentify the RTQA required. A reason for the existence ofdifferences in procedures among the GHG members may bethe nonstandardization of the RT protocol section (27).

The GHG steering committee members strive to reduceRT protocol noncompliance in delineation, planning, andtreatment delivery through their individually establishedRTQA procedures. The procedures follow good clinicalpractice and international standards; however, they differ inquantity, timing, title, and compliance criteria.

The baseline RTQA procedures between the RTQAgroups are the same for each trial and participating site,whereas the preaccrual and prospective/retrospective datacapture and analysis procedures vary per RTQA group andper trial (Table 1), depending among others on the influencethat the RT component may have on the trial’s mainquestion and the level of RT technique complexity that isallowed or in question.

The main differences between the procedures imple-mented by the various RTQA groups are detailed below:

� Baseline: No real differences exist, besides the differentminimum requirements established per the GHG steeringcommittee members.

� Protocol-compliant dummy patient or site connectivitycheck: There are differences in the depth of procedures,depending on the complexity of the trial and the rele-vance of RT to the trial’s question. Some of the pro-cedures only check the site’s connectivity abilities,whereas others also check the protocol compliance on a“dummy patient.”

� Advanced RT technique credentialing: Complex dosim-etry check and credentialing for advanced techniques byRTTQA and TROG use a physical phantom and dosim-eters, both provided by the auditing body. Credentialingfor advanced technology clinical trials by RPC andRTOG can be accomplished using in-house equipment,whereas virtual phantom procedure by EORTC-ROG isalways accomplished using in-house equipment. TheRTTQA, TROG, RPC, and RTOG procedures have anaugmented workload, with the parallel hope ofstrengthening the participants’ knowledge and ability toparticipate in the trial.

� Remote review of patients’ RT treatments: All but one ofthe procedures review the trial patients’ delineations andRT plan prospectively, during patient treatment, orretrospectively, whereas review of patient’s treatmentrecord by RPC also acts as an independent MU calcula-tion procedure but is only carried out retrospectively.

� Site visits: Whereas RTTQA’s procedure consists ofmeasurements of output in reference conditions andcredentialing for advanced techniques, TROG and RPCprocedures also observe the entire treatment process, alsoperforming phantom measurements using a protocol-compliant plan. In addition to that, RPC’s procedureconsists of MU calculations for all trial patients.

An in-depth reading of the definition of each procedureshows that more than half of the 27 procedures havecommon goals but are labelled differently, whereas 4 ofthem are prerequisites to others. Using this information theGHG steering committee members have harmonized theRTQA naming conventions, reducing their number from27 to 10 (Table 2).

The new RTQA procedures are as follows:

� Facility questionnaire: Demographics, workload, and QAequipment and procedures of the site.

� Beam output audit: Beam output measurement underreference conditions.

� Benchmark case: Planning and/or delineation test on acommon CT dataset.

� Dummy run (with or without delineation exercise): Usingimaging data of an in-house patient, this procedure iseither a protocol compliance treatment plan test or asimple connectivity check.

� Complex treatment dosimetry check: Dosimetric test ofadvanced treatment techniques using a phantom providedby the GHG member or approved external dosimetryaudit group.

� Virtual phantom: dosimetric test of advanced treatmenttechniques using in-house phantom.

Table 2 Naming conventions of RTQA procedures of the GHG steering committee members

Naming conventioncategories Current name New name

Baseline Facility questionnaire Facility questionnaireExternal reference dosimetry audit Beam output auditOSLD/TLD beam output auditReference beam output

Preaccrual Benchmark case by RPC and TROG Benchmark caseDry run by ITCDummy run by EORTC-ROG, JCOG, and RTOGOutlining and planning cases/exercises by RTTQADigital data integrity quality assurance Dummy run (without delineation exercise)Dry run by RTOGData submission testBenchmark case by EORTC-ROG, IAEA Dummy run (with delineation exercise)Dummy run by TROGPretrial case reviewRapid reviewCredentialing for advanced technology clinical trials Complex treatment dosimetry checkComplex dosimetry checkCredentialing for advanced techniquesVirtual phantom procedure Virtual phantom

Prospective/retrospectiveRTQA data captureand analysis

Image registration by Advanced TechnologyConsortium (having completenesscheck, basic archiving, computedoseevolume histograms, andreconcile structures as prerequisites)

(Prospective or retrospective) individual casereview

Individual case reviewTimely reviewReview of patients’ treatment records Review of patients’ treatment recordsCase report forms Case report formsOn-site dosimetry review visit by RPC Protocol compliance and dosimetry site visitOn-site dosimetry review visit by TROGOn-site dosimetry visit

Abbreviations as in Table 1.

Melidis et al. International Journal of Radiation Oncology � Biology � Physics1248

� (Prospective or retrospective) individual case review:Review of the actual treatment plan and delineation oftrial patients.

� Review of patients’ treatment records: Retrospective re-view of the actual treatment plan and delineation of trialpatients, combined with measurements and protocolcompliance and dosimetry site visits.

� Case report forms: Review of retrospectively submittedforms by each site on all trial patients concerning theirRT treatment.

� Protocol compliance and dosimetry site visit: Beamoutput audit and complex treatment dosimetry check. Itmay also include observations of the entire treatmentprocess for a trial patient, trial patients’ MU calculations,local QA procedures, and documentation and review oftreatment records.

Discussion

This article presented the various RTQA procedures usedby the GHG steering committee members. Several

differences were found concerning similar procedures. Asan example, the frequency and number of beams to beanalyzed in the beam output audit varies greatly, with RPCand RTOG asking for every machine and energy on a yearlybasis, and EORTC-ROG asking for the lowest and highestenergy every other year. Furthermore, IAEA uses TLDs,RPC, RTOG, and EORTC-ROG use OSLD/TLDs, and inother groups ion chambers or alanine would be acceptable.In addition, the acceptable limits differ, with EORTC-ROGand IAEA requiring results within 5% and RPC and RTOGasking for 3%. Another example is the different reviewingsoftware used among the GHG steering committee mem-bers, as well as the analysis methods, dosimeters, phantomdesigns, and acceptable limits used for the complex treat-ment dosimetry check. Such different compliance criteriacan be seen, for example, when comparing the RPC pro-cedure with the RTTQA one, with the procedure compli-ance criteria for g analysis ranging from 7%/4 mm to 3%/3 mm, respectively (3, 16). The GHG has identified allthese differences and is working toward their harmoniza-tion, keeping in mind the need to apply different trial-specific criteria.

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As yet there is no consensus regarding which RTQAprocedures should be used per trial. Whereas for some trialsa limited QA program is performed, for others veryextensive tests are conducted. It might be worthwhile toinvestigate what the optimal combination for both high trialcompliance and cost-effectiveness of RTQA procedurescould be for a given trial on the basis of the trial specifics,like the trial’s main question, the complexity of the RTgiven, and the design of the study (28). This requiresfurther research into the effectiveness of the various pro-cedures and their combination (29).

Out of the analysis of the 27 procedures that wereidentified among the GHG steering committee members, aharmonized set of 10 procedures was formulated to be usedin all future RT clinical trials.

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