Innovation In Radiation Oncology Research Articles

Use of Radiotherapy in Advanced Breast Cancer: The Role of a Nurse

ObjectivesSystemic therapy is the mainstay in advanced breast cancer (ABC), but innovations in radiation oncology have given radiotherapy a crucial role in the treatment of both intracranial and extracranial ABC. Breast cancer specialists include, in addition to medical and clinical oncologists, breast cancer nurses with unique theoretical knowledge and significant clinical experience. This review aims to discuss the function of radiotherapy in ABC and to highlight the role and importance of specialized nursing care for ABC patients receiving radiotherapy. Data SourcesAn extensive literature review was conducted on the role of radiotherapy and its implementation in various settings of ABC and the pivotal contribution of nursing practices to the quality of life of these patients, with a particular focus on symptom and side effect management and prevention, education, as well as unmet patient needs. The Advanced Breast Cancer International Consensus Guidelines (ABC-5) were also included. All the above data were combined with the expert and practical considerations of breast cancer specialists within the team. ConclusionThe sophisticated application of radiotherapy and the complexity of ABC patient management, concerning symptoms, side effects, and overall well-being necessitate collaborative efforts to optimize patient care. Breast cancer nurses hold a central role in this framework. Implications for Nursing PracticeThe significance of specialized nursing in contributing to comprehensive patient care for ABC patients treated with radiotherapy outlines the need for extensive training that aims to provide a holistic approach and entails physical, mental, and emotional support and patient and caregiver education.

European Cancer Summit 2022 Submission for Health System and Treatment Optimisation NetworkHow a value-based approach can bridge the radiotherapy treatment gaps

BackgroundAlthough radiotherapy is required by more than half of cancer patients, access to radiotherapy remains far from optimal. At least one in four European cancer patients do not receive the radiotherapy they require, and the uptake of innovations in radiation oncology (RO) is often slow and haphazard.Value-based approaches can help bridge these gaps in radiotherapy, especially by facilitating the assessment of new interventions. However, current value-based frameworks in oncology do not sufficiently consider RO specific aspects. For example, the diversity of innovations (from masks to proton beam therapy to AI) that need assessment; the upfront resources or workforces required to support implementation; or the need for non-traditional endpoints to capture adequately the benefits of RO, e.g. organ preservation. MethodsThe Health Economics in Radiation Oncology programme of the European Society for Radiotherapy and Oncology (ESTRO-HERO) has proposed to build a robust value-based framework, specifically for RO interventions, starting a three year project as of October 2021. Literature review, qualitative research and stakeholder consensus building through a Delphi consensus approach will be the main methods used in this project. Exploration and consensus building will be undertaken on questions regarding innovative interventions, outcomes, and evidence required for a certain level of benefit. ResultsA three year project started in October 2021, with the first work package tackling the diversity of innovations in RO interventions. A systematic literature review identified twenty-five papers, providing definitions or classifications of innovations in RO. The ESTRO-HERO group will assess the suitability of these in a value-based context, and propose additional aspects if necessary. Future steps are defining and categorizing suitable outcomes for RO interventions, with an important role for patient representatives as crucial stakeholders. To decide the required magnitude of benefit and level of evidence will link the previous steps, and ultimately allow to build a value-based framework for radiotherapy innovations. ConclusionsBuilding a value-based framework for RO interventions will provide a necessary tool for both clinicians and health policy makers, and provide essential evidence for decision making on a local, national and international scale.

152: A Framework for Real-World Clinical Implementation of Technical Innovations in Radiation Oncology

152: A Framework for Real-World Clinical Implementation of Technical Innovations in Radiation Oncology

Master protocol trial design for technical feasibility of MR-guided radiotherapy

The master protocol trial design aims to increase efficiency in terms of trial infrastructure and protocol administration which may accelerate development of (technical) innovations in radiation oncology. A master protocol to study feasibility of techniques/software for MR-guided adaptive radiotherapy with the MR-Linac is described and discussed.

Analysis of data to Advance Personalised Therapy with MR-Linac (ADAPT-MRL)

BackgroundAnalysis of Data to Advance Personalised Therapy with MR-Linac (ADAPT-MRL) is a multi-site, multinational, observational cohort registry designed to collect data on the use of the magnetic resonance linear accelerator (MR-Linac) for radiation therapy and patient outcomes. The registry will provide a linked repository of technical and clinical data that will form a platform for prospective studies and technology assessment. MethodsDesign: This registry aims to include an estimated 10,000 eligible participants across Australia and other countries over a 7- to 10-year period. Participants will undergo treatment and assessments in accordance with standard practice. Toxicity and survival outcomes will be assessed at baseline, during treatment, and with 3 monthly follow-up until 24 months, patient reported outcome measures will also be collected. Participants with a variety of cancers will be included. DiscussionData obtained from the ADAPT-MRL registry is expected to provide evidence on the safety and efficacy of the MR-Linac, a new technical innovation in radiation oncology. We expect this registry will generate data that will be used to optimise treatment techniques, MR-Linac software algorithms, evaluate participants’ outcomes and toxicities and to create a repository of adapted plans, anatomical and functional MR sequences linked to participants’ outcomes.

Image-guided Adaptive Radiotherapy for Bladder Cancer

Technological advancement has facilitated patient-specific radiotherapy in bladder cancer. This has been made possible by developments in image-guided radiotherapy (IGRT). Particularly transformative has been the integration of volumetric imaging into the workflow. The ability to visualise the bladder target using cone beam computed tomography and magnetic resonance imaging initially assisted with determining the magnitude of inter- and intra-fraction target change. It has led to greater confidence in ascertaining true anatomy at each fraction. The increased certainty of dose delivered to the bladder has permitted the safe reduction of planning target volume margins. IGRT has therefore improved target coverage with a reduction in integral dose to the surrounding tissue. Use of IGRT to feed back into plan and dose delivery optimisation according to the anatomy of the day has enabled adaptive radiotherapy bladder solutions. Here we undertake a review of the stepwise developments underpinning IGRT and adaptive radiotherapy strategies for external beam bladder cancer radiotherapy. We present the evidence in accordance with the framework for systematic clinical evaluation of technical innovations in radiation oncology (R-IDEAL).

Diffusion of innovation in radiation oncology in the United States.

Objective:To develop an instrument for quantifying innovation and assess the diffusion of innovation in radiation oncology (RO) in the United States.Methods:Primary data were collected for using total population convenience sampling. Innovation Score and Innovation Utilization Score were determined using 20 indicators. 240 medical physicists (MPs) practicing in RO in the United States completed a custom Internet-based survey.Results:Centers with no academic affiliation are trailing behind in innovation in total (MD = 1.65, 95% C I[0.38,2.917], p = 0.011, d = 0.351), in patient treatment (MD = 0.39, 95% CI [0.021,0.76], p = 0.038, d = 0.282), and workflow innovation (MD = 7.09, 95% CI [0.78,13.39], p = 0.028, d = 0.330). Centers with no academic affiliation are trailing behind in innovation utilization in total (MD = 0.46, 95% CI [0.05,0.86], p = 0.028, d = 0.188). Rural center are trailing behind in patient positioning in innovation (MD = 0.31, 95% CI [0.011,0.612], p = 0.042, d = 0.293) and innovation utilization (MD = 16.22, 95% CI [0.73,31.72], p = 0.04, d = 0.608). Rural centers are trailing behind in innovative treatments (MD = 0.62, 95% CI [0.23,1.00], p = 0.002, d = 0.457). Motivation (rs = 0.224, p = 0.002) and appreciation (rs = 0.215, p = 0.003) were statistically significant personal factors influencing innovation utilization.Conclusions:There is a wide range of innovation across RO centers in the United States. RO centers in the United States are not practicing as innovative as reasonably achievable.Advances in knowledge:This work quantified how innovative RO in the United States is and results provide guidance on how to improve it in the future.

Three discipline collaborative radiation therapy (3DCRT) special debate: Equipment development is stifling innovation in radiation oncology.

The field of radiation oncology has recently experienced a period of remarkable transformation of our technical capabilities. These technical and computational advancements have resulted in a tremendous improvement in our ability to precisely and accurately deliver radiation dose. However, this increased emphasis on technical capabilities may be inadvertently diverting attention and funding from scientific developments in other areas, even at a time when exciting new advances are occurring in cancer biology. Much of our recent technical development has been promoted and subsidized by the manufacturers of radiation oncology equipment. The question now becomes “who will encourage and subsidize the research needed to bring our recent biological advances to clinical fruition?” In a recent commentary which inspired this debate, Brown and Adler suggest that we “…are in a golden age of radiation and cancer biology” and that “…the industry's current focus on equipment development alone is undermining significant potential clinical advances in radiation oncology.”3 This is the subject of this month's 3DCRT debate. Arguing for the proposition will be Drs. Leonard Kim, Stephanie Markovina, and Samantha Van Nest. Dr. Leonard Kim has worked on defining microscopic disease target volumes for breast cancer radiotherapy at William Beaumont Hospital and Rutgers Cancer Institute of New Jersey. He is currently Chief Medical Physicist at the MD Anderson Cancer Center at Cooper. Dr. Stephanie Markovina is interested in improving therapeutic response to radiation in cervical cancer and other solid tumors by better understanding molecular mechanisms of radiation induced tumor cell death and survival. She is an Assistant Professor of Radiation Oncology and Cancer Biology at Washington University in St Louis where she specializes primarily in the treatment of patients with gynecologic cancers. Dr. Samantha Van Nest has worked to establish spectroscopic techniques for the personalization of radiation therapy. She is currently a Postdoctoral Associate at Weill Cornell Medicine in New York, where her research investigates the effects of radiation on tumor immunity, with a particular focus on improving our understanding of the abscopal effect. Arguing against the proposition will be Drs. Subarna Eisaman, Lakshmi Santanam, and Julie Sullivan. Dr. Subarna Hamid Eisaman is the clinical director and assistant professor at the University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center Department of Radiation Oncology at the J. Murtha Pavilion in Johnstown, Pennsylvania. She serves as co‐chair of the Radiation Oncology Lung and Lymphoma Via Oncology Pathways Physician Advisory Committee. Her clinical practice includes treatment of breast, GYN, lung, CNS, head and neck, skin and musculoskeletal malignancies. Dr. Lakshmi Santanam is an attending medical physicist at Memorial Sloan Kettering Cancer Center. Her primary interests include motion management and patient safety. She currently serves as vice chair for the AAPM Working Group on RO‐ILS and the Task Group on the Management of Respiratory Motion in Radiation Oncology. Dr. Julie Sullivan is a biologist at the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health. Her scientific interests include the use of radiation‐emitting medical devices in clinical trials and the medical planning for and response to radiological and nuclear incidents.

NCTN clinical trial standardization for radiotherapy through IROC and CIRO.

Evidence-based practice is the cornerstone of modern medicine. Randomized clinical trials across multiple institutions are the gold standard for modern evidence collection. National Cancer Trials Network (NCTN) instruments the clinical trials through the new infrastructure for improvements in cancer treatment. Radiation therapy is an integral component of cancer treatment and is involved in many of the NCTN clinical trials. Radiotherapy is experiencing exciting developments in new treatment modalities and multi-modality image guidance. One of NCTN network groups NRG Oncology brings together the research areas of the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG). The Imaging and Radiation Oncology Core (IROC) and Center for Innovation in Radiation Oncology(CIRO) of NRG Oncology complement each other's functions in development and implementation of the new radiotherapy and imaging technologies in clinical trials with standardization and other strategies for quality. The standardization process is the essential step to make the data collected for clinical trials of high quality, interoperable, and reusable.

R-IDEAL: A Framework for Systematic Clinical Evaluation of Technical Innovations in Radiation Oncology.

The pace of innovation in radiation oncology is high and the window of opportunity for evaluation narrow. Financial incentives, industry pressure, and patients’ demand for high-tech treatments have led to widespread implementation of innovations before, or even without, robust evidence of improved outcomes has been generated. The standard phase I–IV framework for drug evaluation is not the most efficient and desirable framework for assessment of technological innovations. In order to provide a standard assessment methodology for clinical evaluation of innovations in radiotherapy, we adapted the surgical IDEAL framework to fit the radiation oncology setting. Like surgery, clinical evaluation of innovations in radiation oncology is complicated by continuous technical development, team and operator dependence, and differences in quality control. Contrary to surgery, radiotherapy innovations may be used in various ways, e.g., at different tumor sites and with different aims, such as radiation volume reduction and dose escalation. Also, the effect of radiation treatment can be modeled, allowing better prediction of potential benefits and improved patient selection. Key distinctive features of R-IDEAL include the important role of predicate and modeling studies (Stage 0), randomization at an early stage in the development of the technology, and long-term follow-up for late toxicity. We implemented R-IDEAL for clinical evaluation of a recent innovation in radiation oncology, the MRI-guided linear accelerator (MR-Linac). MR-Linac combines a radiotherapy linear accelerator with a 1.5-T MRI, aiming for improved targeting, dose escalation, and margin reduction, and is expected to increase the use of hypofractionation, improve tumor control, leading to higher cure rates and less toxicity. An international consortium, with participants from seven large cancer institutes from Europe and North America, has adopted the R-IDEAL framework to work toward coordinated, evidence-based introduction of the MR-Linac. R-IDEAL holds the promise for timely, evidence-based introduction of radiotherapy innovations with proven superior effectiveness, while preventing unnecessary exposure of patients to potentially harmful interventions.

The MRI-Linear Accelerator Consortium: Evidence-Based Clinical Introduction of an Innovation in Radiation Oncology Connecting Researchers, Methodology, Data Collection, Quality Assurance, and Technical Development.

An international research consortium has been formed to facilitate evidence-based introduction of MR-guided radiotherapy (MR-linac) and to address how the MR-linac could be used to achieve an optimized radiation treatment approach to improve patients’ survival, local, and regional tumor control and quality of life. The present paper describes the organizational structure of the clinical part of the MR-linac consortium. Furthermore, it elucidates why collaboration on this large project is necessary, and how a central data registry program will be implemented.

Within the next five years, adaptive hypofractionation will become the most common form of radiotherapy.

Within the next five years, adaptive hypofractionation will become the most common form of radiotherapy.

Technology for Innovation in Radiation Oncology

Radiation therapy is an effective, personalized cancer treatment that has benefited from technological advances associated with the growing ability to identify and target tumors with accuracy and precision. Given that these advances have played a central role in the success of radiation therapy as a major component of comprehensive cancer care, the American Society for Radiation Oncology (ASTRO), the American Association of Physicists in Medicine (AAPM), and the National Cancer Institute (NCI) sponsored a workshop entitled "Technology for Innovation in Radiation Oncology," which took place at the National Institutes of Health (NIH) in Bethesda, Maryland, on June 13 and 14, 2013. The purpose of this workshop was to discuss emerging technology for the field and to recognize areas for greater research investment. Expert clinicians and scientists discussed innovative technology in radiation oncology, in particular as to how these technologies are being developed and translated to clinical practice in the face of current and future challenges and opportunities. Technologies encompassed topics in functional imaging, treatment devices, nanotechnology, and information technology. The technical, quality, and safety performance of these technologies were also considered. A major theme of the workshop was the growing importance of innovation in the domain of process automation and oncology informatics. The technologically advanced nature of radiation therapy treatments predisposes radiation oncology research teams to take on informatics research initiatives. In addition, the discussion on technology development was balanced with a parallel conversation regarding the need for evidence of efficacy and effectiveness. The linkage between the need for evidence and the efforts in informatics research was clearly identified as synergistic.

WE-AB-BRA-07: Quantitative Evaluation of 2D-2D and 2D-3D Image Guided Radiation Therapy for Clinical Trial Credentialing, NRG Oncology/RTOG

Purpose: 2D-2D kV image guided radiation therapy (IGRT) credentialing evaluation for clinical trial qualification was historically qualitative through submitting screen captures of the fusion process. However, as quantitative DICOM 2D-2D and 2D-3D image registration tools are implemented in clinical practice for better precision, especially in centers that treat patients with protons, better IGRT credentialing techniques are needed. The aim of this work is to establish methodologies for quantitatively reviewing IGRT submissions based on DICOM 2D-2D and 2D-3D image registration and to test the methodologies in reviewing 2D-2D and 2D-3D IGRT submissions for RTOG/NRG Oncology clinical trials qualifications. Methods: DICOM 2D-2D and 2D-3D automated and manual image registration have been tested using the Harmony tool in MIM software. 2D kV orthogonal portal images are fused with the reference digital reconstructed radiographs (DRR) in the 2D-2D registration while the 2D portal images are fused with DICOM planning CT image in the 2D-3D registration. The Harmony tool allows alignment of the two images used in the registration process and also calculates the required shifts. Shifts calculated using MIM are compared with those submitted by institutions for IGRT credentialing. Reported shifts are considered to be acceptable if differences are less than 3mm. Results: Several tests have been performed on the 2D-2D and 2D-3D registration. The results indicated good agreement between submitted and calculated shifts. A workflow for reviewing these IGRT submissions has been developed and will eventually be used to review IGRT submissions. Conclusion: The IROC Philadelphia RTQA center has developed and tested a new workflow for reviewing DICOM 2D-2D and 2D-3D IGRT credentialing submissions made by different cancer clinical centers, especially proton centers. NRG Center for Innovation in Radiation Oncology (CIRO) and IROC RTQA center continue their collaborative efforts to enhance quality assurance services and to be consistently adaptive to the new advances in radiation therapy. This project was supported by NCI grants U10CA180868, U10CA180822, U24CA180803, U24CA12014 and PA CURE Grant.

MO‐E‐BRF‐01: Research Opportunities in Technology for Innovation in Radiation Oncology (Highlight of ASTRO NCI 2013 Workshop)

Radiotherapy is one of the most effective treatments for solid tumors, in large part due to significant technological advances associated with, for instance, the ability to target tumors to very high levels of accuracy (within millimeters). Technological advances have played a central role in the success of radiation therapy as an oncologic treatment option for patients. ASTRO, AAPM and NCI sponsored a workshop “Technology for Innovation in Radiation Oncology” at the NCI campus in Bethesda, MD on June 13–14, 2013. The purpose of this workshop was to bring together expert clinicians and scientists to discuss the role of disruptive technologies in radiation oncology, in particular with regard to how they are being developed and translated to clinical practice in the face of current and future challenges and opportunities. The technologies discussed encompassed imaging and delivery aspects, along with methods to enable/facilitate application of them in the clinic. Measures for assessment of the performance of these technologies, such as techniques to validate quantitative imaging, were reviewed. Novel delivery technologies, incorporating efficient and safe delivery mechanisms enabled by development of tools for process automation and the associated field of oncology informatics formed one of the central themes of the workshop. The discussion on disruptive technologies was grounded in the need for evidence of efficacy. Scientists in the areas of technology assessment and bioinformatics provided expert views on different approaches toward evaluation of technology efficacy. Clinicians well versed in clinical trials incorporating disruptive technologies (e.g. SBRT for early stage lung cancer) discussed the important role of these technologies in significantly improving local tumor control and survival for these cohorts of patients. Recommendations summary focused on the opportunities associated with translating the technologies into the clinic and assessing their efficacy, and provided a glimpse into the future.Learning Objectives: To understand the impact of technology on the field of radiation therapy To learn about the trends of technology development for the field of radiation oncology To understand the opportunities for in innovative technology research

Protection of quality and innovation in radiation oncology

The technical progress in radiotherapy in recent years has been tremendous. This also implies a change of human and time resources. However, there is a lack of data on this topic. Therefore, the DEGRO initiated several studies in the QUIRO project on this subject. The present publication focuses on results for tomotherapy systems and compares them with other IMRT techniques. Over a period of several months, time allocation was documented using a standard form at two university hospitals. The required time for individual steps in the treatment planning process was recorded for all involved professional groups (physicist, technician, and physician) by themselves. The time monitoring at the treatment machines was performed by auxiliary employees (student research assistants). Evaluation of the data was performed for all recorded data as well as by tumor site. A comparison was made between the two involved institutions. A total of 1,691 records were analyzed: 148 from head and neck (H&N) tumors, 460 from prostate cancer, 136 from breast cancer, and 947 from other tumor entities. The mean value of all data from both centers for the definition of the target volumes for H&N tumors took a radiation oncology specialist 75 min, while a physicist needed for the physical treatment planning 214 min. For prostate carcinomas, the times were 60 and 147 min, respectively, and for the group of other entities 63 and 192 min, respectively. For the first radiation treatment, the occupancy time of the linear accelerator room was 31, 26, and 30 min for each entity (H&N, prostate, other entities, respectively). For routine treatments 22, 18, and 21 min were needed for the particular entities. Major differences in the time required for the individual steps were observed between the two centers. This study gives an overview of the time and personnel requirements in radiation therapy using a tomotherapy system. The most representative analysis could be done for the room occupancy times during treatment in both centers. Due to the partly small amount of data and differing planning workflows between the two centers, it is problematic to draw a firm conclusion with regard to planning times. Overall, the time required for the tomotherapy treatment and planning is slightly higher compared to other IMRT techniques.

Protection of quality and innovation in radiation oncology: The prospective multicenter trial the German Society of Radiation Oncology (DEGRO-QUIRO study)

A number of national and international societies published recommendations regarding the required equipment and manpower assumed to be necessary to treat a number of patients with radiotherapy. None of these recommendations were based on actual time measurements needed for specific radiotherapy procedures. The German Society of Radiation Oncology (DEGRO) was interested in substantiating these recommendations by prospective evaluations of all important core procedures of radiotherapy in the most frequent cancers treated by radiotherapy. The results of the examinations of radiotherapy with intensity-modulated radiation therapy (IMRT) in patients with different tumor entities are presented in this manuscript. Four radiation therapy centers [University Hospital of Marburg, University Hospital of Giessen, University Hospital of Berlin (Charité), Klinikum rechts der Isar der Technischen Universität München] participated in this prospective study. The workload of the different occupational groups and room occupancies for the core procedures of radiotherapy were prospectively documented during a 2-month period per center and subsequently statistically analyzed. The time needed per patient varied considerably between individual patients and between centers for all the evaluated procedures. The technical preparation (contouring of target volume and organs at risk, treatment planning, and approval of treatment plan) was the most time-consuming process taking 3 h 54 min on average. The time taken by the medical physicists for this procedure amounted to about 57%. The training part of the preparation time was 87% of the measured time for the senior physician and resident. The total workload for all involved personnel comprised 74.9 min of manpower for the first treatment, 39.7 min for a routine treatment with image guidance, and 22.8 min without image guidance. The mean room occupancy varied between 10.6 min (routine treatment without image guidance) and 23.7 min (first treatment with image guidance). The prospective data presented here allow for an estimate of the required machine time and manpower needed for the core procedures of radiotherapy in an average radiation treatment with IMRT. However, one should be aware that a number of necessary and time-consuming activities were not evaluated in the present study.

The QUIRO Study (assurance of quality and innovation in radiooncology): methodology, instruments and practices

The QUIRO study aimed to establish a secure level of quality and innovation in radiation oncology. Over 6years, 27specific surveys were conducted at 24radiooncological departments. In all, 36renowned experts from the field of radiation oncology (mostly head physicians and full professors) supported the realization of the study. A salient feature of the chosen methodological approach is the "process" as a means of systematizing diversified medical-technical procedures according to standardized criteria. On the one hand, "processes" as a tool of translation are adapted for creating and transforming standards into concrete clinical and medical actions; on the other hand, they provide the basis for standardized instruments and methods to determine the required needs of physicians, staff, and equipment. In the foreground of the collection and measurement of resource requirements were the processes of direct service provision which were subdivided into modules for reasons of clarity and comprehensibility. Overhead tasks (i.e., participation in quality management) were excluded from the main study and examined in a separate survey with appropriate methods. After the exploration of guidelines, tumor- or indication-specific examination and treatment processes were developed in expert workshops. Moreover, those specific modules were defined which characterize these entities and indications in a special degree. Afterwards, these modules were compiled according to their time and resources required in the "reference institution", i.e., in specialized and as competent recognized departments (mostly from the university area), by various suitable survey methods. The significance of the QUIRO study and the validity of the results were optimized in a process of constant improvements and comprehensive checks. As a consequence, the QUIRO study yields representative results concerning the resource requirement for specialized, qualitatively and technologically highly sophisticated radiooncologic treatment in Germany.

Comparative Effectiveness Research in Radiation Oncology: Stereotactic Radiosurgery, Hypofractionation, and Brachytherapy

Radiation oncology encompasses a diverse spectrum of treatment modalities, including stereotactic radiosurgery, hypofractionated radiotherapy, and brachytherapy. Though all these modalities generally aim to do the same thing-treat cancer with therapeutic doses of radiation while relatively sparing normal tissue from excessive toxicity, the general radiobiology and physics underlying each modality are distinct enough that their equivalence is not a given. Given the continued innovation in radiation oncology, the comparative effectiveness of these modalities is important to review. Given the broad scope of radiation oncology, this article focuses on the 3 most common sites requiring radiation treatment: breast, prostate, and lung cancer.

Evaluation of novel radiotherapy technologies: what evidence is needed to assess their clinical and cost effectiveness, and how should we get it?

Technical innovations in radiation oncology--eg, intensity-modulated radiotherapy, stereotactic radiotherapy, and particle therapy--can be developed rapidly and introduced into the clinic even when costs associated with their use are much higher than those for conventional radiotherapy. Although clinical benefit is expected on the basis of superior biological and physical characteristics, data for clinical effectiveness of new radiotherapy techniques are scarce. Evidence from randomised clinical trials would be ideal but such studies focus mostly on new drugs. High investment costs and modifications over time make evaluation of novel radiotherapy technologies in clinical trials more complex. Here, we propose an algorithm for evaluation of the clinical and cost effectiveness of novel radiotherapy technologies. We suggest situations when randomised trials might be feasible and the type of trial that should be undertaken when they are not. Furthermore, we discuss the usefulness of dose-distribution models for estimation of expected clinical benefit and for selection of the patients' population with the highest expected benefit. Economic modelling, including the approach of real options analysis, can inform whether implementation of a technology should begin (based on available evidence) or be delayed (until further data are available), and it can indicate the best trial design and required sample size.