Prospecting for Gold in Imaging and Radiotherapy: identifying and addressing next generation challenges

Advances in therapeutic strategies have made the clinical picture much more complex. Treatments that address underlying biological mechanisms are becoming part of routine clinical practice; the use of FDG-PET in staging and diagnosis and the incorporation of biologically targeted treatments such as trastuzmab and rituximab into the standard of care for some cancers are clear examples of this.

Undeniably, these new multidisciplinary approaches to the treatment of cancer are ushering in an era of personalized medicine, and this will change the requirements needed to conduct cancer clinical research. Studies will require the contributions of a host of specialists, e.g. pathologists, laboratory scientists, and imaging and quality assurance specialists, all of whom must be integrated into the translational research programmes of clinical trials.

The EORTC has been mobilizing to integrate these specialists into its clinical trials.

In order to stress the need and current opportunities in imaging, the EORTC created the Imaging Group as a separate entity, and an Imaging Platform was set up to handle imaging data. The Quality Assurance of Radiotherapy (QA RT) program had already been in place and active for a number of years.

Quality Assurance at the EORTC

Quality assurance is an integral part of every aspect of the treatment of cancer and particularly the conduct of clinical trials.  Advances in imaging and therapy require this process to expand to greater breadth and depth.  The EORTC has extensive experience in the field of QA RT which is enabling it to identify and address the challenges ushered in by the new generation of cancer treatments and assessment methods.[1][2]

Since the EORTC Radiation Oncology Group (ROG) first embarked on a widespread and transparent approach to QA RT there have been major advances in the field.  Treatment planning based on clinical mark-up or orthogonal radiographs has been superseded by complex three-dimensional planning utilizing dedicated CT (and in some cases MRI) scans and incorporating data from multiple diagnostic imaging modalities.  High degrees of conformality of the irradiated volume to the target volume and the modification and modulation of treatment to account for day-to-day and second-to-second variations in the location of the tumour or normal tissues are now possible.

To address the QA RT challenges that arise from these developments the EORTC ROG has identified clear minimum requirements for institutions participating in clinical trials in radiotherapy (REF), and a series of QA RT levels for implementation in clinical trials based on the planning of a dummy case (Dummy Run or Dry Run procedure, DR), the detailed review of the treatment of actual trial cases (Individual Case Review, ICR) and the independent assessment of the delivery of simple and complex treatments (External Reference Dosimetry Audit, ERDA, and Complex Dosimetry Check, CDC, respectively).[3][4]

The current standard of QA RT now involves the exchange of full digital imaging and treatment data between institutions and the EORTC.  Previously it was necessary to identify a few critical parameters to be collected on paper-based case report forms; now it is possible to collect the entire treatment plan, alongside the relevant imaging from diagnostic, treatment planning and follow-up studies, and review and analyse it as a whole.  A QA RT/Radiotherapy Database will grow alongside the Imaging Platform and the other clinical EORTC databases.

Combining Translational Research Resources

Through its imaging and radiotherapy infrastructure the EORTC will now be able to collect detailed imaging and full radiotherapy data to complement its extensive clinical, quality of life, pathological and translational research databases. These resources will add further dimensions to the analysis of endpoints in clinical trials.  Multimodality imaging (Imaging database) and detailed 3D radiotherapy treatment data (RT database) can be combined with biological factors (TR Biobank) and clinical data (VISTA clinical database) to more accurately reflect and analyse the complex interactions occurring in every cancer patient.  This opens up new and exciting avenues for research into our understanding and personalisation of a patient’s treatment for cancer.

A more complex picture brings greater challenges for the quality assurance of new technologies and treatments, but the EORTC remains committed to the goal of improving clinical outcome for all cancer patients through the conduct of clinical trials and is setting the infrastructure in place to allow the next generation of developments to achieve its full potential.

 Paul Fenton, Akos Gulyban, and John Bean

[1] Kouloulias VE, Poortmans PM, Bernier J, et al.: The Quality Assurance programme of the Radiotherapy Group of the European Organization for Research and Treatment of Cancer (EORTC): a critical appraisal of 20 years of continuous efforts. Eur J Cancer 39:430-437, 2003.

[2] Poortmans PM, Davis JB, Ataman F, et al.: The quality assurance programme of the Radiotherapy Group of the European Organisation for Research and Treatment of Cancer: past, present and future. Eur J Surg Oncol 31:667-674, 2005.

[3] Budiharto T, Musat E, Poortmans P, et al.: Profile of European radiotherapy departments contributing to the EORTC Radiation Oncology Group (ROG) in the 21st century. Radiother Oncol 88:403-410, 2008.

[4] Horiot JC, Bernier J, Johansson K-A, et al.: Minimum requirements for quality assurance in radiotherapy. Radiotherapy and Oncology 29:103-104, 1993.

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