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. 2023 Sep 14;13(9):e068906.
doi: 10.1136/bmjopen-2022-068906.

Evaluation of hypofractionated adaptive radiotherapy using the MR Linac in localised pancreatic cancer: protocol summary of the Emerald-Pancreas phase 1/expansion study located at Oxford University Hospital, UK

Suliana Teoh  1   2 , Alexander Ooms  3 , Ben George  4 , Rob Owens  2   4 , Kwun-Ye Chu  1   2 , Joe Drabble  4 , Maxwell Robinson  2 , Matthew J Parkes  5 , Lynda Swan  1 , Lucinda Griffiths  1 , Killian Nugent  2   4 , James Good  4 , Tim Maughan  1   2 , Somnath Mukherjee  6   2
Affiliations

Evaluation of hypofractionated adaptive radiotherapy using the MR Linac in localised pancreatic cancer: protocol summary of the Emerald-Pancreas phase 1/expansion study located at Oxford University Hospital, UK

Suliana Teoh et al. BMJ Open. .

Abstract

Introduction: Online adaptive MR-guided radiotherapy allows for dose escalation to pancreatic cancer while sparing surrounding critical organs. We seek to evaluate the safety of delivering hypofractionated five-fraction, three-fraction and single-fraction MR-guided stereotactic ablative radiotherapy (SABR) to the pancreas.

Methods and analysis: This is a single-centre three-arm phase 1 non-randomised safety study. Patients with localised pancreatic cancer will receive either 50 Gy in five (biological equivalent dose (BED10)=100 Gy), 39 Gy in three (BED10=90 Gy) or 25 Gy in a single fraction (BED10=87.5 Gy) MR-guided daily online adaptive radiotherapy. Each fractionation regimen will be assessed as independent cohorts to determine tolerability, assessed continuously using Bayesian conjugate posterior beta distributions. The primary endpoint of the study is to establish the safety of five-fraction, three-fraction and single-fraction MR-guided hypofractionation SABR in localised pancreatic cancer by assessing dose-limiting toxicities. Secondary endpoints include overall survival, progression-free survival, local control rates, overall control rate, resection rates, long-term toxicities and freedom from second-line chemotherapy. This study plans to also explore imaging and immune biomarkers that may be useful to predict outcome and personalise treatment. The trial will recruit up to 60 patients with a safety run-in.

Ethics and dissemination: The trial is approved by the West Midlands-Black Country Research Ethics Committee 22/WM/0122. The results will be disseminated via conference presentations, peer-reviewed scientific journals and submission to regulatory authorities. The data collected for the study, including individual participant data, will be made available to researchers on request to the study team and with appropriate reason, via octo-enquiries@oncology.ox.ac.uk. The shared data will be deidentified participant data and will be available for 3 years following publication of the study. Data will be shared with investigator support, after approval of a proposal and with a signed data access agreement.

Trial registration number: ISRCTN10557832.

Keywords: Hepatobiliary tumours; Magnetic resonance imaging; Radiation oncology.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Trial recruitment phases. DLT, dose-limiting toxicities.
Figure 2
Figure 2
Trial schema and overview of follow-up. MDT, multidisciplinary team; RT, radiotherapy.
See this image and copyright information in PMC

References

    1. Iacobuzio-Donahue CA, Fu B, Yachida S, et al. . DPC4 gene status of the primary carcinoma correlates with patterns of failure in patients with Pancreatic cancer. J Clin Oncol 2009;27:1806–13. 10.1200/JCO.2008.17.7188 - DOI - PMC - PubMed
    1. Chuong MD, Springett GM, Freilich JM, et al. . Stereotactic body radiation therapy for locally advanced and borderline Resectable Pancreatic cancer is effective and well tolerated. Int J Radiat Oncol Biol Phys 2013;86:516–22. 10.1016/j.ijrobp.2013.02.022 - DOI - PubMed
    1. Mahadevan A, Miksad R, Goldstein M, et al. . Induction Gemcitabine and stereotactic body radiotherapy for locally advanced Nonmetastatic Pancreas cancer. Int J Radiat Oncol Biol Phys 2011;81:e615–22. 10.1016/j.ijrobp.2011.04.045 - DOI - PubMed
    1. Chang DT, Schellenberg D, Shen J, et al. . Stereotactic radiotherapy for Unresectable adenocarcinoma of the pancreas. Cancer 2009;115:665–72. 10.1002/cncr.24059 - DOI - PubMed
    1. Didolkar MS, Coleman CW, Brenner MJ, et al. . Image-guided stereotactic radiosurgery for locally advanced Pancreatic adenocarcinoma results of first 85 patients. J Gastrointest Surg 2010;14:1547–59. 10.1007/s11605-010-1323-7 - DOI - PubMed

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