A phase II study of intraoperative radiotherapy using a low-energy x-ray source for resectable pancreatic cancer: a study protocol

Jun Won Kim, Yeona Cho, Hyung Sun Kim, Won Hoon Choi, Joon Seong Park, Ik Jae Lee, Jun Won Kim, Yeona Cho, Hyung Sun Kim, Won Hoon Choi, Joon Seong Park, Ik Jae Lee

Abstract

Background: The current standard treatment for resectable pancreatic cancer is surgical resection followed by adjuvant chemotherapy. Local recurrence rates are high even after curative resection; thus, the long-term outcome of locally advanced pancreatic cancer remains poor. Intraoperative radiotherapy (IORT) uses a low-energy x-ray source to deliver a single fraction of high-dose radiation to the tumor bed during a surgical procedure, while effectively sparing the surrounding normal tissues. IORT has the potential to improve the efficacy of radiation therapy for pancreatic cancer.

Methods/design: This prospective, one-armed, phase II study will investigate the role of IORT in improving local control in patients with resectable pancreatic adenocarcinoma. The patients will receive surgery and IORT of 10 Gy prescribed at a 5-mm depth of the tumor bed, followed by adjuvant gemcitabine chemotherapy according to the current standard of care. The aim is to enroll 42 patients.

Discussion: The primary endpoint of this trial is to evaluate the feasibility of IORT and the local recurrence rate after one year. The secondary endpoints include the acute and late toxicities, and disease-free survival and overall survival rates.

Trial registration: The trial was prospectively registered at Clinicaltrials.gov NCT03273374 on September 6, 2017.

Keywords: Intraoperative radiotherapy; Local control; Low-energy x-ray source; Resectable pancreatic cancer.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Treatment schedule
Fig. 2
Fig. 2
The Intrabeam IORT procedure

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