Intraoperative Radiation Therapy For Resectable Pancreatic Cancer

Study Overview

Intraoperative Radiation Therapy for Resectable Pancreatic Cancer

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.

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.

Resectable Pancreatic Adenocarcinoma

DEVICE: Intraoperative radiation therapy (IORT)

3-2017-0171

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2017-09-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-09-11
First Submitted that Met QC Criteria 2017-09-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-09-13
First Posted (ACTUAL) 2017-09-06	Results First Posted N/A	Last Verified 2023-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: IORT group Intraoperative radiation therapy of 10 Gy delivered during surgery followed by adjuvant gemcitabine chemotherapy	DEVICE: Intraoperative radiation therapy (IORT) IORT with 50 kV x-ray will be delivered during surgery as a single dose of 10 Gy at 5 millimeter depths of the tumor bed, followed by gemcitabine chemotherapy (1000 mg/m2) every 4 weeks for a total of 6 cycles

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: IORT group

Intraoperative radiation therapy of 10 Gy delivered during surgery followed by adjuvant gemcitabine chemotherapy

DEVICE: Intraoperative radiation therapy (IORT)

IORT with 50 kV x-ray will be delivered during surgery as a single dose of 10 Gy at 5 millimeter depths of the tumor bed, followed by gemcitabine chemotherapy (1000 mg/m2) every 4 weeks for a total of 6 cycles

Primary Outcome Measures	Measure Description	Time Frame
Local recurrence rate	Local recurrence rate	12 months

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

1. Pathologically confirmed pancreatic adenocarcinoma 2. Age ≥20 years 3. Performance status ECOG 0-2 4. Patients must have resectable disease. In order to be resectable the following criteria must be met:
Absence of distant metastases
Clear fat planes around the celiac axis, hepatic artery, and superior mesenteric artery
Absence of direct involvement of inferior vena cava or aorta
Stage I-III disease per AJCC 7th edition 5. Laboratory data obtained ≤14 days prior to registration on study, with adequate bone marrow and renal function defined as follows:
Hemoglobin >10 g/dL, Absolute Neutrophil Count (ANC) >1,500/mm3, Platelets >100,000/mm3
Serum Cr <1.4 mg/dL, BUN <20 mg/dL 6. Ability to understand and the willingness to sign a written informed consent

1. Patients who have received external beam radiotherapy in the abdominal area 2. Defined treatment area which cannot be adequately covered by the radiation field as defined by the radiation oncology treatment team 3. Patients who have received neoadjuvant chemotherapy 4. Stage IV disease 5. Patients with distant metastases 6. Current pregnancy or currently nursing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Ik Jae Lee, Gangnam Severance Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Cho Y, Kim JW, Kim HS, Park JS, Lee IJ. Intraoperative Radiotherapy for Resectable Pancreatic Cancer Using a Low-Energy X-Ray Source: Postoperative Complications and Early Outcomes. Yonsei Med J. 2022 May;63(5):405-412. doi: 10.3349/ymj.2022.63.5.405.
Lee YS, Kim HS, Cho Y, Lee IJ, Kim HJ, Lee DE, Kang HW, Park JS. Intraoperative radiation therapy induces immune response activity after pancreatic surgery. BMC Cancer. 2021 Oct 12;21(1):1097. doi: 10.1186/s12885-021-08807-3.
Kim JW, Cho Y, Kim HS, Choi WH, Park JS, Lee IJ. A phase II study of intraoperative radiotherapy using a low-energy x-ray source for resectable pancreatic cancer: a study protocol. BMC Surg. 2019 Mar 7;19(1):31. doi: 10.1186/s12893-019-0492-x.

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