Ying Xiao

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 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