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Intraoperative Radiation Therapy for Resectable Pancreatic Cancer

NCT03273374 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-09-13

No results posted yet for this study

Summary

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.

Conditions

  • Resectable Pancreatic Adenocarcinoma

Interventions

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

Sponsors & Collaborators

  • Gangnam Severance Hospital

    lead OTHER

Principal Investigators

  • Ik Jae Lee · Gangnam Severance Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-14
Primary Completion
2020-08-21
Completion
2022-08-22

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03273374 on ClinicalTrials.gov