Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2017 Aug;193(8):630-638.
doi: 10.1007/s00066-017-1153-6. Epub 2017 Jun 12.

Quality assurance of the PREOPANC trial (2012-003181-40) for preoperative radiochemotherapy in pancreatic cancer : The dummy run

Eva Versteijne  1 , Eelco Lens  2 , Astrid van der Horst  2 , Arjan Bel  2 , Jorrit Visser  2 , Cornelis J A Punt  3 , Mustafa Suker  4 , Casper H J van Eijck  4 , Geertjan van Tienhoven  2
Affiliations
Multicenter Study

Quality assurance of the PREOPANC trial (2012-003181-40) for preoperative radiochemotherapy in pancreatic cancer : The dummy run

Eva Versteijne et al. Strahlenther Onkol. 2017 Aug.

Abstract
in English, German

Background: The Dutch Pancreatic Cancer Group initiated the national, multicentre, controlled PREOPANC trial, randomising between preoperative radiochemotherapy and direct explorative laparotomy for patients with (borderline) resectable pancreatic cancer. The aim of this dummy run is to evaluate compliance with the radiotherapy protocol of this trial, and the quality of delineation and radiation plans.

Methods: Eleven radiation oncology departments open for accrual of patients in the PREOPANC trial were provided with all necessary information of a selected 'dummy' patient. Each institute was asked to delineate the target volumes, including gross tumour volume, internal gross tumour volume (iGTV), internal clinical target volume, and planning target volume. The institutions were also asked to provide a radiation treatment plan in accordance with the PREOPANC trial protocol.

Results: The range of the iGTV was 19.3-77.2 cm3 with a mean iGTV of 41.5 cm3 (standard deviation 14.8 cm3). Nine institutions made a treatment plan using an arc technique for treatment delivery, one an intensity modulated technique and one a 3-field conformal technique. All institutions reached the prescribed target coverage, without exceeding the organs at risk constraints. The institution with the 3‑field conformal technique was advised to use a more sophisticated technique (e. g. volumetric modulated arc therapy) to reduce the dose to the spinal cord.

Conclusion: All institutions showed acceptable deviations from the PREOPANC trial protocol and achieved an acceptable quality of delineation and radiation technique. All institutions were allowed to continue participation in the PREOPANC trial.

Hintergrund: Die niederländische Gruppe für Bauchspeicheldrüsenkrebs (Dutch Pancreatic Cancer Group, DPCG) initiierte die nationale und multizentral kontrollierte PREOPANC-Studie, worin die präoperative Radiochemotherapie mit der direkten explorativen Laparotomie für Patienten mit (grenzwertig) resektablen Pankreaskarzinomen verglichen wird. Ziel des „dummy runs“ ist es, die Übereinstimmung mit dem Strahlentherapieprotokoll dieser Studie und die Qualität der Zielvolumenkonturierung und der Bestrahlungspläne zu evaluieren.

Methoden: Insgesamt 11 Abteilungengen für Radioonkologie, die offen für Patienten der PREOPANC-Studie waren, erhielten alle notwendigen Informationen für einen ausgewählten „Dummy“-Patienten. Jedes Institut wurde gebeten, die Zielvolumina einzuzeichnen, einschließlich des makroskopischen Tumorvolumens, des internen makroskopischen Tumorvolumens (iGTV), des internen klinischen Zielvolumens und des Planungszielvolumens. Außerdem erstellte jedes Institut einen Bestrahlungsplan in Übereinstimmung mit dem PREOPANC-Protokoll.

Ergebnisse: Der Bereich des iGTV betrug 19,3–77,2 cm3 mit einem durchschnittlichen iGTV von 41,5 cm3 (Standardabweichung 14,8 cm3). Es wurden 9 VMAT-Pläne, ein IMRT-Plan und ein Plan mittels konformaler 3‑Felder-Technik erstellt. Alle Institutionen erreichten die vorgeschriebene Zielabdeckung ohne Einschränkung oder Überschreitung der erlaubten Dosis in den Risikoorganen. Der Institution, die die 3‑Felder-Technik verwendete, wurde empfohlen, eine anspruchsvollere Technik (z. B. volumenmodulierte Arc-Therapie) zu verwenden, um die Rückenmarkdosis zu reduzieren.

Schlussfolgerung: Alle Institutionen zeigten akzeptable Abweichungen vom PREOPANC-Studienprotokoll und erreichten eine akzeptable Qualität der Zielvolumenkonturierung und der Bestrahlungstechnik. Allen Institutionen wurde die weitere Teilnahme an der PREOPANC-Studie erlaubt.

Electronic supplementary material: The online version of this article (doi:10.1007/s00066-017-1153-6) contains supplementary material, which is available to authorized users. Supplementary material: PREOPANC Protocol, version 11, radiotherapy part

Keywords: Clinical protocols; Clinical trial; Computed tomography; Fiducial markers; Planning techniques.

PubMed Disclaimer

Conflict of interest statement

Conflict of interest

A. Bel does consultancy work for Elekta and is the project leader of several Elekta-sponsored projects outside of this work. Elekta had no involvement in study design, data collection and analysis, or writing of the manuscript; E. Versteijne, E. Lens, A. van der Horst, J. Visser, C.J. A. Punt, M. Suker, C.H.J. van Eijck and G. van Tienhoven declare that they have no competing interests.

Ethical standards

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study for the PREOPANC trial.

Figures

Fig. 1
Fig. 1
Gross tumour volumes (GTVs) of one institution (red) and internal gross tumour volumes (iGTVs) of 10 institutions projected on the average scan of the four-dimensional computed tomography (4DCT). One intratumoural fiducial marker is visible within the delineated target. Colours: institution 1: orange; 2: yellow; 3: light blue; 4: green; 5: pink; 6: dark green; 7: brown; 8: dark blue; 9: black; 10: red, 11: purple
Fig. 2
Fig. 2
Planning target volumes (PTVs) of the 11 institutions projected on the average scan of the four-dimensional computed tomography (4DCT), with one intratumoural fiducial marker visible within the PTVs. Colours: institution 1: orange; 2: yellow; 3: light blue; 4: green; 5: pink, 6: dark green; 7: brown; 8: dark blue; 9: black; 10: red; 11: purple
Fig. 3
Fig. 3
Box plots of a the conformity index (CI) of the treatment plan, b the volume of internal gross tumour volumes (iGTVs) and planning target volumes (PTV) and c the doses to the organs at risk (OARs) of the 11 institutions. Boxes: median value and upper and lower quartiles; whiskers: lowest and highest data point within 1.5 × interquartile range; dots: outliers
See this image and copyright information in PMC

References

    1. http://eco.iarc.fr/EUCAN/Cancer.aspx?Cancer=15, EUCAN World Health Organization. Accessed April 2016
    1. Jemal A, Siegel R, Ward E, et al. Cancer statistics. CA Cancer J Clin. 2009;59:225–224. doi: 10.3322/caac.20006. - DOI - PubMed
    1. http://www.cijfersoverkanker.nl/selecties/Dataset_1/img5710ff45b4b50, IKNL accessed April 2016.
    1. http://www.cancerresearchuk.org/health-professional/cancer-statistics/st..., Cancer research UK, accessed April 2016
    1. Gillen S, Schuster T, Meyer Zum Büschenfelde C, et al. Preoperative/neoadjuvant therapy in pancreatic cancer: a systematic review and meta-analysis of response and resection percentages. PLoS Med. 2010;7(4):e1000267. doi: 10.1371/journal.pmed.1000267. - DOI - PMC - PubMed

Publication types

MeSH terms

LinkOut - more resources