Joel Saltz

By Thomas J. FitzGerald, Maryann Bishop-Jodoin, Fran Laurie, Richard Hanusik, Matthew Iandoli, Kathryn Karolczuk, Sandra Kessel, Fred Prior, Joel Saltz, Ashish Sharma, Michael Knopp, Mark Rosen, Ying Xiao, David Followill, Jeff Michalski, M. Giulia Cicchetti and Janaki Moni

Imaging in neuro-oncology clinical trials can be used to validate patient eligibility, stage at presentation, response to therapy, and radiation therapy. A number of National Clinical Trials Network trials illustrating this are presented. Through the Imaging and Radiation Oncology Core’s quality assurance processes for data acquisition and review, there are uniform data and imaging sets for review. Once the trial endpoints have been analyzed and published, the clinical trial information including pathology, imaging, and radiation therapy objects can be moved to a public archive for use by investigators interested in translational science and the application of new informatics tools for trial analysis.

Part of the book: Neuroimaging

By Linda Ding, Carla D. Bradford, Kenneth Ulin, Koren Smith, I-Lin Kuo, Yankhua Fan, Abdulnasser Khalifeh, Fenghong Liu, Suhong Lu, Harry Bushe, Salvatore Larosa, Camelia Bunaciu, Jonathan Saleeby, Shannon Higgins, Julie Trifone, Maureen Britton, Joshua Taylor, Marious Croos, Katie Figura, Thomas Quinn, Linda O’Connor, Kathleen Briggs, Sherri Suhl, Jean Quigley, Heather Reifler, Shawn Kirby, Fred Prior, Joel Saltz, Maryann Bishop-Jodoin and Thomas J. FitzGerald

Technology and computational analytics are moving forward at an extraordinary rate with changes in patient care and department workflows. This rapid pace of change often requires initiating and maintaining the educational support at multiple levels to introduce technology to radiation oncology staff members. Modern physics quality assurance and dosimetry treatment planning now require expertise beyond traditional skill based in computational algorithms and image management including quality assurance of the process of image acquisition and fusion of image datasets. Expertise in volumetric anatomy and normal tissue contouring are skills now performed by physics/dosimetry in collaboration with physicians and these skills are required in modern physics dosimetry training programs. In this chapter, challenges of modern radiation planning are reviewed for each disease site. Skills including future applications of image integration into planning objects and the future utility of artificial intelligence in modern radiation therapy treatment planning are reviewed as these issues will need to be added to modern training programs.

Part of the book: Dosimetry

By Thomas J. FitzGerald, Fran Laurie, Matthew Iandoli, Maryann Bishop-Jodoin, Koren Smith, Kenneth Ulin, Janaki Moni, Maria Giulia Cicchetti, Stephen Kry, Michael Knopp, Ying Xiao, Mark Rosen, Fred Prior and Joel Saltz

Clinical trials in radiation oncology have improved our translational science and patient care. All patients referred to departments of radiation oncology can be invited to participate in a clinical trial with multiple venues. Study endpoints can include intradepartmental endpoints to improve workflow and patient access as well as interdepartmental clinical translational trials that include the National Clinical Trials Network (NCTN) and industry. The quality of the trial is important to trial outcome and influences interpretation of the results of the study and how the results can be applied to patient care moving forward. Clinical trials in radiation oncology to date have accomplished much, however many important questions remain as patient care matures and systemic therapies become more sophisticated and associated with specific biomarkers and cellular expression products. In this chapter we review the history of clinical trials in radiation oncology and review the current status of the structure of quality assurance in clinical trials. We will review unanswered questions and areas to study in each disease area and how to design strategy for trials to address modern unmet needs in our discipline.

Part of the book: Frontiers in Clinical Trials

By Koren Smith, Linda Ding, Maryann Bishop-Jodoin, Matt Iandoli, Fran Laurie, Stephen Kry, Michael Knopp, Mark Rosen, Ying Xiao, Fred Prior, Joel Saltz and Thomas J. FitzGerald

Clinical trials in radiation oncology are the best vehicle to optimize our strengths in therapeutic technology, define progress in our field, and improve patient outcome. Trials advance our knowledge in each disease site and provide us information to improve the radiation dose-volume for both tumor control and therapeutic sequelae to normal tissue. An increasing number of systemic and targeted therapies have been developed and are currently in early phase clinical trial design. Ultimately, these new therapies will need to be tested with standard-of-care therapy including radiation oncology. Therefore, during a study, it is essential that radiation therapy is delivered in a uniform and consistent manner for the credibility of the study. If the radiation therapy component of the study does not have a structure or management for maintaining therapeutic compliance, including a real-time data management strategy, it becomes difficult to trust the study outcome and apply the outcome to daily clinical practice. In this chapter, we review the strategy and process involved in the management of dosimetry in radiation oncology clinical trials and how this can impact clinical trial management, primary study endpoints, and the overall success of the study.

Part of the book: Advances in Dosimetry and New Trends in Radiopharmaceuticals