Pancreatic Cancer Research

Clinical trialNACompleted

Intraoperative Radiation Therapy for Resectable Pancreatic Cancer

A Prospective, Phase II Study Investigating Efficacy of Intraoperative Radiation Therapy for Resectable Pancreatic Cancer

NCT03273374↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Finished, no results posted
Phase
NA
Status
Completed
Study type
Interventional
Start
14 August 2017
Expected end
22 August 2022
Enrollment
42 participants
Sites
1
Primary outcomes
Local recurrence rate
Sponsor
Other
Results posted
No
Last update
13 September 2023

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Brief summary public domain (ClinicalTrials.gov)

This phase II study is designed to investigate the efficacy of IORT for patients with resectable pancreatic adenocarcinoma. The purpose of the study is to show the local recurrence rate after surgical resection and IORT is superior to that of surgical resection alone from the historical control. A total of 42 patients will be enrolled, and these patients will receive IORT of 10 Gy at 5 millimeter depth of the tumor bed, followed by 6 cycles of adjuvant gemcitabine chemotherapy.

Detailed description public domain (ClinicalTrials.gov)

Treatment outcomes of pancreatic cancer are poor even after surgical resection, thus patients may receive adjuvant chemotherapy or chemoradiotherapy. Intraoperative radiotherapy (IORT) with low energy (50 kV) x-ray allows delivery of a high dose radiation to the tumor bed during surgery while effectively sparing adjacent critical organs. Another advantage of IORT is that delivery of IORT does not interfere with the scheduled administration of adjuvant chemotherapy or chemoradiotherapy. Here we investigate the efficacy of IORT for patients with resectable pancreatic adenocarcinoma by comparing the local recurrence rate after surical resection and IORT with that of surgical resection alone from the historical control. A total of 42 patients will be enrolled in this phase II trial, and these patients will receive IORT of 10 Gy at 5 millimeter depth of the tumor bed, followed by 6 cycles of adjuvant gemcitabine chemotherapy.

Papers 3