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Review
. 2016 Feb 1;94(2):404-11.
doi: 10.1016/j.ijrobp.2015.10.028. Epub 2015 Oct 24.

Imaging and Data Acquisition in Clinical Trials for Radiation Therapy

Thomas J FitzGerald  1 , Maryann Bishop-Jodoin  2 , David S Followill  3 , James Galvin  4 , Michael V Knopp  5 , Jeff M Michalski  6 , Mark A Rosen  7 , Jeffrey D Bradley  8 , Lalitha K Shankar  9 , Fran Laurie  2 , M Giulia Cicchetti  10 , Janaki Moni  10 , C Norman Coleman  9 , James A Deye  9 , Jacek Capala  9 , Bhadrasain Vikram  9
Affiliations
Review

Imaging and Data Acquisition in Clinical Trials for Radiation Therapy

Thomas J FitzGerald et al. Int J Radiat Oncol Biol Phys. .

Abstract

Cancer treatment evolves through oncology clinical trials. Cancer trials are multimodal and complex. Assuring high-quality data are available to answer not only study objectives but also questions not anticipated at study initiation is the role of quality assurance. The National Cancer Institute reorganized its cancer clinical trials program in 2014. The National Clinical Trials Network (NCTN) was formed and within it was established a Diagnostic Imaging and Radiation Therapy Quality Assurance Organization. This organization is Imaging and Radiation Oncology Core, the Imaging and Radiation Oncology Core Group, consisting of 6 quality assurance centers that provide imaging and radiation therapy quality assurance for the NCTN. Sophisticated imaging is used for cancer diagnosis, treatment, and management as well as for image-driven technologies to plan and execute radiation treatment. Integration of imaging and radiation oncology data acquisition, review, management, and archive strategies are essential for trial compliance and future research. Lessons learned from previous trials are and provide evidence to support diagnostic imaging and radiation therapy data acquisition in NCTN trials.

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Figures

Figure 1
Figure 1
a. IROC is within the NCTN Centralized Functions. Reprinted from The National Cancer Institute, 2015. (5) b. The IROC Core. Previous QA centers (top) that merged into IROC (bottom). Reprinted with permission from ASTROnews, 2014. (6)
Figure 2
Figure 2
POG 8725 Survival according to treatment- retrospective subset analysis. Reprinted with permission from Int J Radiat Oncol Biol Phys, 2008 (4).
Figure 3
Figure 3
Adapted from COG Protocol AHOD0031 schema displaying the real-time review assessment points. Central imaging reviews confirmed RER after two cycles of chemotherapy and CR after two additional cycles of chemotherapy. RT treatment objects were reviewed in real time prior to RT start. Reprinted from Front Oncol, 2013 (9).
Figure 4
Figure 4
Overall survival by deviation status in the TROG 02.02 HeadSTART trial: (1) compliant from outset (n = 502), (2) made compliant following QARC review (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. Reprinted with permission from J Clin Oncol, 2010. (16)
Figure 5
Figure 5
IROC Centers and Case Review in the NCTN. IROC Houston plays an essential role in providing credentialing services for participating RT sites in NCTN trials.
See this image and copyright information in PMC

References

    1. Glicksman AS, Reinstein LE, McShan D, et al. Radiotherapy quality assurance program in a cooperative group. Int J Radiat Oncol Biol Phys. 1981;7:1561–1568. - PubMed
    1. Glicksman AS, Wasserman TH, Bjarngard B, et al. The structure for a radiation oncology protocol. The Committee of Radiation Oncology Group Chairmen. Int J Radiat Oncol Biol Phys. 1992;23:1079–1082. - PubMed
    1. Donaldson SS, Torrey M, Link MP, et al. A multidisciplinary study investigating radiotherapy in Ewing’s sarcoma: end results of POG #8346. Pediatric Oncology Group. Int J Radiat Oncol Biol Phys. 1998;42:125–135. - PubMed
    1. FitzGerald TJ, Urie M, Ulin K, et al. Processes for quality improvements in radiation oncology clinical trials. Int J Radiat Oncol Biol Phys. 2008;71(Suppl 1):S76–9. - PMC - PubMed
    1. The National Cancer Institute. [Accessed September 24, 2015];Infographics from NCI: NCI National Clinical Trials Network Structure. http://www.cancer.gov/PublishedContent/Images/research/areas/clinical-tr.... Updated May 29, 2015.

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