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Clinical Trial
. 2016 Aug;120(2):212-6.
doi: 10.1016/j.radonc.2016.07.002. Epub 2016 Aug 3.

Comparison of investigator-delineated gross tumour volumes and quality assurance in pancreatic cancer: Analysis of the on-trial cases for the SCALOP trial

Emmanouil Fokas  1 , Emiliano Spezi  2 , Neel Patel  3 , Chris Hurt  4 , Lisette Nixon  4 , Kwun-Ye Chu  5 , John Staffurth  6 , Ross Abrams  7 , Somnath Mukherjee  8
Affiliations
Clinical Trial

Comparison of investigator-delineated gross tumour volumes and quality assurance in pancreatic cancer: Analysis of the on-trial cases for the SCALOP trial

Emmanouil Fokas et al. Radiother Oncol. 2016 Aug.

Abstract

Background and purpose: We performed a retrospective central review of tumour outlines in patients undergoing radiotherapy in the SCALOP trial.

Materials and methods: The planning CT scans were reviewed retrospectively by a central review team, and the accuracy of investigators' GTV (iGTV) and PTV (iPTV) was compared to the trials team-defined gold standard (gsGTV and gsPTV) using the Jaccard Conformity Index (JCI) and Geographical Miss Index (GMI). The prognostic value of JCI and GMI was also assessed. The RT plans were also reviewed against protocol-defined constraints.

Results: 60 patients with diagnostic-quality planning scans were included. The median whole volume JCI for GTV was 0.64 (IQR: 0.43-0.82), and the median GMI was 0.11 (IQR: 0.05-0.22). For PTVs, the median JCI and GMI were 0.80 (IQR: 0.71-0.88) and 0.04 (IQR: 0.02-0.12) respectively. Tumour was completely missed in 1 patient, and⩾50% of the tumour was missed in 3. Patients with JCI for GTV⩾0.7 had 7.12 (95% CIs: 1.83-27.67, p=0.005) higher odds of progressing by 9months in multivariate analysis. Major deviations in RT planning were noted in 4.5% of cases.

Conclusions: Radiotherapy workshops and real-time central review of contours are required in RT trials of pancreatic cancer.

Keywords: Conformity index; Pancreas; Prospective trial; Quality assurance; Radiotherapy.

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Figures

Fig. 1
Fig. 1
Scatter plot showing the correlation of the Geographical Miss Index (GMI) and the Jaccard Conformity Index (JCI) with (A) the investigator gross tumour volumes (iGTVs) and (B) the investigator planning target volumes (iPTVs).
Fig. 2
Fig. 2
Distributions of the JCI and GMI indices by progression status at 9 months.
Fig. 3
Fig. 3
Illustration of the relationship between on-trial planning assessment form (PAF) value and the Visualization and Organization of Data for Cancer Analysis programme (VODCA) values in n = 66 cases, as indicated (A–F). Minor deviations are shown with black squares. Incorrect identification of the ipsilateral kidney (C) occurred in two cases (shown with circle).
See this image and copyright information in PMC

References

    1. Abrams R.A., Winter K.A., Regine W.F., Safran H., Hoffman J.P., Lustig R. Failure to adhere to protocol specified radiation therapy guidelines was associated with decreased survival in RTOG 9704–a phase III trial of adjuvant chemotherapy and chemoradiotherapy for patients with resected adenocarcinoma of the pancreas. Int J Radiat Oncol Biol Phys. 2012;82:809–816. - PMC - PubMed
    1. Roques T.W. Patient selection and radiotherapy volume definition – Can we improve the weakest links in the treatment chain? Clin Oncol (R Coll Radiol) 2014;26:353–355. - PubMed
    1. Peters L.J., O’Sullivan B., Giralt J., Fitzgerald T.J., Trotti A., Bernier J. Critical impact of radiotherapy protocol compliance and quality in the treatment of advanced head and neck cancer: results from TROG 02.02. J Clin Oncol. 2010;28:2996–3001. - PubMed
    1. Weber D.C., Tomsej M., Melidis C., Hurkmans C.W. QA makes a clinical trial stronger: evidence-based medicine in radiation therapy. Radiother Oncol. 2012;105:4–8. - PubMed
    1. Ben-Josef E., Lawrence T.S. Radiotherapy: the importance of local control in pancreatic cancer. Nat. Rev. Clin. Oncol. 2012;9:9–10. - PubMed

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