The Importance of Imaging in Radiation Oncology for National Clinical Trials Network Protocols

Abstract

Imaging is essential in successfully executing radiation therapy (RT) in oncology clinical trials. As technically sophisticated diagnostic imaging and RT were incorporated into trials, quality assurance in the National Clinical Trials Network groups entered a new era promoting image acquisition and review. Most trials involving RT require pre- and post-therapy imaging for target validation and outcome assessment. The increasing real-time (before and during therapy) imaging and RT object reviews are to ensure compliance with trial objectives. Objects easily transmit digitally for review from anywhere in the world. Physician interpretation of imaging and image application to RT treatment plans is essential for optimal trial execution. Imaging and RT data sets are used to credential RT sites to confirm investigator and institutional ability to meet trial target volume delineation and delivery requirements. Real-time imaging and RT object reviews can be performed multiple times during a trial to assess response to therapy and application of RT objects. This process has matured into an effective data management mechanism. When necessary, site and study investigators review objects together through web media technologies to ensure the patient is enrolled on the appropriate trial and the intended RT is planned and executed in a trial-compliant manner. Real-time imaging review makes sure: (1) the patient is entered and eligible for the trial, (2) the patient meets trial-specific adaptive therapy requirements, if applicable, and (3) the intended RT is according to trial guidelines. This review ensures the study population is uniform and the results are believable and can be applied to clinical practice.

Figure 1.

Survival According to Treatment (POG 8725). Reprinted from International Journal of Radiation Oncology* Biology*Physics, 71/1, FitzGerald T. J., Urie M., Ulin K., Laurie F., Yorty J., Hanusik R., et al., Processes for quality improvements in radiation oncology clinical trials. S76-S79. Doi: http://dx.doi.org/10.1016/j.ijrobp.2007.07.2387. Copyright (2008), with permission from Elsevier. (6).

Figure 2.

Adapted from COG Protocol, AHOD0031 schema displaying the real time review assessment points. Reprinted from Frontiers in Oncology, Future vision for the quality assurance of oncology clinical trials. 3:31, FitzGerald T. J., Bishop-Jodoin M., Bosch W. R., Curran W. J., Followill D. S., Galvin J. M., Hanusik R., King S. R., Knopp M. V., Laurie F., O’Meara W., Michalski J. M., Saltz J. H., Schnall M. D., Schwartz L., Ulin K., Xiao Y., Urie M. doi: 10.3389/fonc.2013.00031. Copyright (2013), This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in other forums, provided the original authors and source are credited and subject to any copyright notices concerning any third-party graphics etc. (8).

Figure 3.

Overall survival by deviation status: (1) compliant from the outset (n = 502), (2) made compliant following a review by the Quality Assurance Review Center (n = 86), (3) noncompliant but without predicted major adverse impact on tumor control (n = 105), and (4) noncompliant with predicted major adverse impact on tumor control (n = 87). Overall P < .001. Pair-wise tests: not statistically significant except for cohort 1 versus cohort 4 (P < .001), cohort 2 versus cohort 4 (P = .041), and cohort 3 versus cohort 4 (P = .006). TCP, tumor control probability; RT, radiotherapy. Pending permissions. (9).