Abstract
BackgroundThe 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/designThis 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.DiscussionThe 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 registrationThe trial was prospectively registered at Clinicaltrials.gov NCT03273374 on September 6, 2017.
Highlights
The current standard treatment for resectable pancreatic cancer is surgical resection followed by adjuvant chemotherapy
The primary endpoint of this trial is to evaluate the feasibility of Intraoperative radiotherapy (IORT) and the local recurrence rate after one year
IORT has the potential to improve the efficacy of radiation therapy for pancreatic cancer by reducing radiation dose to the normal tissue and allowing the escalation of radiation dose to the tumor bed to further improve local control [9, 10]
Summary
The current standard treatment for resectable pancreatic cancer is surgical resection followed by adjuvant chemotherapy. Local recurrence rates are high even after curative resection; 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. The efficacy of EBRT in pancreatic cancer is limited by the difficulty of delivering an adequate dose of radiation due to the limited tolerance of critical organs, including the stomach, small bowel, kidney, liver, and spinal cord. Intraoperative radiation therapy (IORT) delivers a single fraction of high-dose radiation to the tumor bed after gross total
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