Literature DB >> 25539374

Global harmonization of quality assurance naming conventions in radiation therapy clinical trials.

Christos Melidis1, Walther R Bosch2, Joanna Izewska3, Elena Fidarova4, Eduardo Zubizarreta4, Kenneth Ulin5, Satoshi Ishikura6, David Followill7, James Galvin8, Annette Haworth9, Deidre Besuijen10, Catharine H Clark, Clark H Clark11, Elizabeth Miles12, Edwin Aird12, Damien C Weber13, Coen W Hurkmans14, Dirk Verellen15.   

Abstract

PURPOSE: To review the various radiation therapy quality assurance (RTQA) procedures used by the Global Clinical Trials RTQA Harmonization Group (GHG) steering committee members and present the harmonized RTQA naming conventions by amalgamating procedures with similar objectives. METHODS AND MATERIALS: A survey of the GHG steering committee members' RTQA procedures, their goals, and naming conventions was conducted. The RTQA procedures were classified as baseline, preaccrual, and prospective/retrospective data capture 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 committee members vary in quantity, timing, name, and compliance criteria. The procedures of each member are based on perceived chances of noncompliance, so that the quality of radiation therapy planning and treatment does not negatively influence the trial measured outcomes. A comparison of these procedures demonstrated similarities among the goals of the various methods, but the naming given to each differed. After thorough discussions, the GHG steering committee members amalgamated the 27 RTQA procedures to 10 harmonized ones with corresponding names: facility questionnaire, beam output audit, benchmark case, dummy run, complex treatment 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 used in all future clinical trials involving radiation therapy, have been established. Harmonized procedures will facilitate future intergroup trial collaboration and help to ensure comparable RTQA between international trials, which enables meta-analyses and reduces RTQA workload for intergroup studies.
Copyright © 2014 Elsevier Inc. All rights reserved.

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Year:  2014        PMID: 25539374     DOI: 10.1016/j.ijrobp.2014.08.348

Source DB:  PubMed          Journal:  Int J Radiat Oncol Biol Phys        ISSN: 0360-3016            Impact factor:   7.038


  14 in total

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Authors:  S Adebahr; S Collette; E Shash; M Lambrecht; C Le Pechoux; C Faivre-Finn; D De Ruysscher; H Peulen; J Belderbos; R Dziadziuszko; C Fink; M Guckenberger; C Hurkmans; U Nestle
Journal:  Br J Radiol       Date:  2015-04-15       Impact factor: 3.039

Review 2.  Personalized radiotherapy: concepts, biomarkers and trial design.

Authors:  A H Ree; K R Redalen
Journal:  Br J Radiol       Date:  2015-05-20       Impact factor: 3.039

3.  Prospective review of radiotherapy trials through implementation of standardized multicentre workflow and IT infrastructure.

Authors:  Sarah Gwynne; Gareth Jones; Rhydian Maggs; David Eaton; Elizabeth Miles; John Staffurth; Lisette Nixon; Ruby Ray; Geraint Lewis; Tom Crosby; Emiliano Spezi
Journal:  Br J Radiol       Date:  2016-06-01       Impact factor: 3.039

4.  Dependence of volume calculation and margin growth accuracy on treatment planning systems for stereotactic radiosurgery.

Authors:  David J Eaton; Kevin Alty
Journal:  Br J Radiol       Date:  2017-10-12       Impact factor: 3.039

Review 5.  Imaging and Data Acquisition in Clinical Trials for Radiation Therapy.

Authors:  Thomas J FitzGerald; Maryann Bishop-Jodoin; David S Followill; James Galvin; Michael V Knopp; Jeff M Michalski; Mark A Rosen; Jeffrey D Bradley; Lalitha K Shankar; Fran Laurie; M Giulia Cicchetti; Janaki Moni; C Norman Coleman; James A Deye; Jacek Capala; Bhadrasain Vikram
Journal:  Int J Radiat Oncol Biol Phys       Date:  2015-10-24       Impact factor: 7.038

6.  The radiotherapy quality assurance gap among phase III cancer clinical trials.

Authors:  Kelsey L Corrigan; Stephen Kry; Rebecca M Howell; Ramez Kouzy; Joseph Abi Jaoude; Roshal R Patel; Anuja Jhingran; Cullen Taniguchi; Albert C Koong; Mary Fran McAleer; Paige Nitsch; Claus Rödel; Emmanouil Fokas; Bruce D Minsky; Prajnan Das; C David Fuller; Ethan B Ludmir
Journal:  Radiother Oncol       Date:  2021-11-25       Impact factor: 6.280

7.  Radiotherapy dosimetry audit: three decades of improving standards and accuracy in UK clinical practice and trials.

Authors:  Catharine H Clark; Edwin G A Aird; Steve Bolton; Elizabeth A Miles; Andrew Nisbet; Julia A D Snaith; Russell A S Thomas; Karen Venables; David I Thwaites
Journal:  Br J Radiol       Date:  2015-09-02       Impact factor: 3.039

8.  Executive summary of AAPM Report Task Group 113: Guidance for the physics aspects of clinical trials.

Authors:  Jean M Moran; Andrea Molineu; Jon J Kruse; Mark Oldham; Robert Jeraj; James M Galvin; Jatinder R Palta; Arthur J Olch
Journal:  J Appl Clin Med Phys       Date:  2018-06-29       Impact factor: 2.102

9.  IDEAL-CRT: A Phase 1/2 Trial of Isotoxic Dose-Escalated Radiation Therapy and Concurrent Chemotherapy in Patients With Stage II/III Non-Small Cell Lung Cancer.

Authors:  David B Landau; Laura Hughes; Angela Baker; Andrew T Bates; Michael C Bayne; Nicholas Counsell; Angel Garcia-Alonso; Susan V Harden; Jonathan D Hicks; Simon R Hughes; Marianne C Illsley; Iftekhar Khan; Virginia Laurence; Zafar Malik; Helen Mayles; William Philip M Mayles; Elizabeth Miles; Nazia Mohammed; Yenting Ngai; Emma Parsons; James Spicer; Paula Wells; Dean Wilkinson; John D Fenwick
Journal:  Int J Radiat Oncol Biol Phys       Date:  2016-03-28       Impact factor: 7.038

10.  PEACE V - Salvage Treatment of OligoRecurrent nodal prostate cancer Metastases (STORM): a study protocol for a randomized controlled phase II trial.

Authors:  A De Bruycker; A Spiessens; P Dirix; N Koutsouvelis; I Semac; N Liefhooghe; A Gomez-Iturriaga; W Everaerts; F Otte; A Papachristofilou; M Scorsetti; M Shelan; S Siva; F Ameye; M Guckenberger; R Heikkilä; P M Putora; A Zapatero; A Conde-Moreno; F Couñago; F Vanhoutte; E Goetghebeur; D Reynders; T Zilli; P Ost
Journal:  BMC Cancer       Date:  2020-05-12       Impact factor: 4.430

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