Global Harmonization of Quality Assurance Naming Conventions in Radiation Therapy Clinical Trials

Melidis, Christos; Bosch, W.R.; Iżewska, J.; Fidarova, Elena; Zubizarreta, Eduardo; Ulin, Kenneth; Ishikura, Satoshi; Followill, David S; Galvin, James M.; Haworth, Annette; Besuijen, Deidre; Clark, Catharine H.; Miles, Elizabeth; Aird, Edwin; Weber, Damien Charles; Hurkmans, Coen; Verellen, Dirk

doi:10.1016/j.ijrobp.2014.08.348

Cited by 47 publications

(39 citation statements)

References 24 publications

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“…The goals are to collate, homogenize and distribute information regarding the radiotherapy quality assurance standards across audit groups, provide a platform for prospective discussions on new audit procedures, software tools, guidelines and policies and provide a framework to endorse existing and future audit procedures and guidelines across various trial groups. 58 Recent work 59 has included harmonizing the nomenclature for volume naming across international trials.…”

Section: International Links and Harmonizationmentioning

confidence: 99%

“…The main contributors are currently the NPL, RTTQA and the IPEM interdepartmental audit groups; however, there are also links with other international groups such as the ACDS, TROG, EORTC and IROC. On an international level, the Global Harmonisation Group now meets regularly and several co-ordinated projects have been completed 58,59 or are under way.…”

Section: Recent Developments In Auditmentioning

confidence: 99%

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

Clark

Aird

Bolton

et al. 2015

BJR

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Dosimetry audit plays an important role in the development and safety of radiotherapy. National and large scale audits are able to set, maintain and improve standards, as well as having the potential to identify issues which may cause harm to patients. They can support implementation of complex techniques and can facilitate awareness and understanding of any issues which may exist by benchmarking centres with similar equipment. This review examines the development of dosimetry audit in the UK over the past 30 years, including the involvement of the UK in international audits. A summary of audit results is given, with an overview of methodologies employed and lessons learnt. Recent and forthcoming more complex audits are considered, with a focus on future needs including the arrival of proton therapy in the UK and other advanced techniques such as four-dimensional radiotherapy delivery and verification, stereotactic radiotherapy and MR linear accelerators. The work of the main quality assurance and auditing bodies is discussed, including how they are working together to streamline audit and to ensure that all radiotherapy centres are involved. Undertaking regular external audit motivates centres to modernize and develop techniques and provides assurance, not only that radiotherapy is planned and delivered accurately but also that the patient dose delivered is as prescribed.

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Section: International Links and Harmonizationmentioning

confidence: 99%

Section: Recent Developments In Auditmentioning

confidence: 99%

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

Clark

Aird

Bolton

et al. 2015

BJR

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“…The RTQA procedure aims to ensure for each treatment plan an acceptable level of conformity to the protocol guidelines. 82 The process includes the requirement to submit a benchmark case for review prior to entry of the first patient in the trial (Figure 3). During the recruitment phase, all treatment plans are sent for a prospective central review by a team of experts, who will decide whether the patient is allowed to be treated based on the treatment plan provided (Figure 4).…”

mentioning

confidence: 99%

LungTech, an EORTC Phase II trial of stereotactic body radiotherapy for centrally located lung tumours: a clinical perspective

Adebahr¹,

Collette²,

Shash³

et al. 2015

BJR

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Evidence supports stereotactic body radiotherapy (SBRT) as a curative treatment option for inoperable early stage nonsmall-cell lung cancer (NSCLC) resulting in high rates of tumour control and low risk of toxicity. However, promising results are mainly derived from SBRT of peripheral pulmonary lesions, whereas SBRT for the central tumours can lead to severe radiation sequelae owing to the spatial proximity to the serial organs at risk. Robust data on the tolerance of mediastinal structures to high-dose hypofractionated radiation are limited; furthermore, there are many open questions regarding the efficiency, safety and response assessment of SBRT in inoperable, centrally located early stage NSCLC, which are addressed in a prospective multicentre study [sponsored by the European Organization for Research and Treatment of Cancer (EORTC 22113-08113-LungTech)]. In this review, we summarize the current status regarding SBRT for centrally located early stage NSCLC that leads to the rationale of the LungTech trial. Outline and some essential features of the study with focus on a summary of current experiences in dose/fraction-toxicity coherences after SBRT to the mediastinal structures that lead to LungTech normal tissue constraints are provided.Stereotactic body radiotherapy (SBRT) is a technique in which high doses of radiotherapy are very precisely delivered with steep dose gradients and a short overall treatment time (OTT). This achieves a very high biological dose.1 Evidence supports SBRT as a curative treatment option for inoperable early stage non-small-cell-lung cancer (NSCLC).2-5 Highprecision, hypofractionated dose delivery enables a significant reduction in both target volume size and exposure of normal tissue (NT) to high doses, resulting in a decreased toxicity risk and high rates of local control.6-8 However, promising results are mainly derived from the SBRT of small peripheral pulmonary lesions with low risk of treatment-related toxicity, as these tumours are surrounded by parallel organs at risk (OARs), specifically lung tissue. In contrast, the SBRT for central tumours can lead to severe, potentially life-threatening radiation sequelae owing to the spatial proximity to serial OARs. As robust, prospective and multicentre data on the tolerance of mediastinal structures to high-dose hypofractionated radiation is limited, there is generally caution in implementing SBRT for central lung tumours. Current published data are rather inconsistent regarding the definition of "central tumour", SBRT techniques, dose prescription and reporting, calculation algorithms, image guidance and evaluation of outcome. A recent systematic review has summarized the current limited evidence on this topic, mainly from singlecentre experiences, 9 but there are still many open questions

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“…The importance of compliance in trials and the impact on detecting changes in outcome have been demonstrated in a number of trials,1, 2, 3, 4, 6 such as TROG 02.02 on advanced head and neck cancer (Fig. 1), and in meta‐analyses of other trials.…”

Section: Introduction and Charge Of The Reportmentioning

confidence: 98%

“…Improved planning tools such as those with knowledge‐based planning have been needed for some time to provide detailed feedback to institutions on whether or not their treatment plans not only meet the dose‐volume histogram requirements but are also optimal for use in clinical trials. With respect to quality assurance requirements, there are important ongoing efforts toward global harmonization of quality assurance6 (such as structure nomenclature addressed by AAPM Task Group (TG) 2638) for radiation therapy clinical trials.…”

Section: Introduction and Charge Of The Reportmentioning

confidence: 99%

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

Moran

Molineu

Kruse

et al. 2018

J Applied Clin Med Phys

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The charge of AAPM Task Group 113 is to provide guidance for the physics aspects of clinical trials to minimize variability in planning and dose delivery for external beam trials involving photons and electrons. Several studies have demonstrated the importance of protocol compliance on patient outcome. Minimizing variability for treatments at different centers improves the quality and efficiency of clinical trials. Attention is focused on areas where variability can be minimized through standardization of protocols and processes through all aspects of clinical trials. Recommendations are presented for clinical trial designers, physicists supporting clinical trials at their individual clinics, quality assurance centers, and manufacturers.

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Global Harmonization of Quality Assurance Naming Conventions in Radiation Therapy Clinical Trials

Cited by 47 publications

References 24 publications

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

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

LungTech, an EORTC Phase II trial of stereotactic body radiotherapy for centrally located lung tumours: a clinical perspective

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

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