Intraoperative Radiation Therapy for Resectable Pancreatic Cancer

NCT05181488 | Active Not Recruiting DMC

• 1 other identifier: 3-2020-0038
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Pancreatic cancer; Intraoperative radiotherapy; neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• post-operative complication

  3 year after intraoperative radiotherapy

• disease free survival

  1 year and 2 year after intraoperative radiotherapy.

• Overall survival

  1 year and 2 year after intraoperative radiotherapy.

Study Arms (1)

IORT group

EXPERIMENTAL

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

Radiation: intraoperative radiotherapy, IORT

Interventions

intraoperative radiotherapy, IORT 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.

IORT group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically diagnosed with adenocarcinoma of the pancreas or clinically diagnosed with imaging examinations or tumor markers
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yona Cho: lead

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Intervention: intraoperative radiotherapy

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: January 6, 2022
• Study Start: April 2, 2020
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

KR (1)