Intraoperative Radiation Therapy for Resectable Pancreatic Cancer

NCT ID: NCT05181488

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-02
• Study Completion Date: 2026-04-01

Brief Summary

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.

Conditions

Resectable Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IORT group

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

Group Type: EXPERIMENTAL

intraoperative radiotherapy, IORT

Intervention Type: RADIATION

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 applicator, and the exact irradiation time is calculated after checking the quality assurance of the radiation generator before treatment every day.

Interventions

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 applicator, and the exact irradiation time is calculated after checking the quality assurance of the radiation generator before treatment every day.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yona Cho

OTHER

Sponsor Role: lead

Responsible Party

Yona Cho

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Gangnam Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

3-2020-0038

Identifier Type: -

Identifier Source: org_study_id