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 intraoperative radiotherapy after neoadjuvant chemotherapy in patients with resectable pancreatic cancer. The purpose of the study is to show the local recurrence rate after neoadjuvant chemotherapy and IORT is superior to that of surgical resection alone from the historical control. A total of 80 patients will be enrolled, and these patients will receive IORT of 10 Gy at 5 millimeter depth of the tumor bed, following neoadjuvant chemotherapy.

N/A

Resectable Pancreatic Cancer

RADIATION: intraoperative radiotherapy, IORT

3-2020-0038

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 2021-12-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-04-11
First Submitted that Met QC Criteria 2022-01-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-04-15
First Posted (ACTUAL) 2022-01-06	Results First Posted N/A	Last Verified 2024-04

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	RADIATION: intraoperative radiotherapy, IORT A dose of 10 Gy is prescribed to be irradiated at a depth of 5 mm from the surface of the applicator, and the radiation oncologist determines the exact irradiation time. The irradiation time may take 20 to 60 minutes depending on the size of the applicato

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: IORT group

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

RADIATION: intraoperative radiotherapy, IORT

A dose of 10 Gy is prescribed to be irradiated at a depth of 5 mm from the surface of the applicator, and the radiation oncologist determines the exact irradiation time. The irradiation time may take 20 to 60 minutes depending on the size of the applicato

Primary Outcome Measures	Measure Description	Time Frame
3-year local recurrence rate	A local recurrence is defined as reappearance of cancer in the ipsilateral preserved breast or chest wall. The 3-year local recurrence rate is calculated using the Kaplan-Meier method.	3 year after intraoperative radiotherapy

Secondary Outcome Measures	Measure Description	Time Frame
post-operative complication	Evaluation of safety, including adverse events, was performed by the Principal Investigator and delegated participating investigators in the Department of Surgery and Radiation Oncology outpatient clinic. Toxicity is evaluated within 3 months (acute) and thereafter (chronic) after surgery, and it is performed through a questionnaire and physical examination at every visit up to 1 year after surgery and recorded.	3 year after intraoperative radiotherapy
disease free survival	Disease-free survival is defined as the time from intraoperative radiotherapy to recurrence of tumor, death or last patient contact.	1 year and 2 year after intraoperative radiotherapy.
Overall survival	Overall survival was defined as the time from intraoperative radiotherapy to death or last patient contact.	1 year and 2 year after intraoperative radiotherapy.

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:

Histologically diagnosed with adenocarcinoma of the pancreas or clinically diagnosed with imaging examinations or tumor markers
20 years or older
Performance status 0-2 based on Eastern Cooperative Oncology Group (ECOG)
Patients with surgically resectable or borderline resectable and advanced pancreatic cancer that can be resected after neoadjuvant chemotherapy
Patients who voluntarily decided to participate in this clinical study and signed a written informed consent

History of previous abdominal irradiation.
When the treatment area is not included in the appropriate radiation field according to the judgment of the radiation oncologist or Durgeon
Distant metastasis
Other systemic conditions that, under the judgment of the attending physician, would be difficult to undergo surgery or radiiotherapy

Collaborators and Investigators

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

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

No publications available

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Clinical Trial Record