Intraoperative Radiation Therapy for Resectable Pancreatic Cancer

Resectable Pancreatic Cancer Clinical Trial

Official title:

A Prospective, Phase II Study Evaluating the Efficacy of Intraoperative Radiotherapy After Neoadjuvant Chemotherapy in Patients With Resectable Pancreatic Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05181488
• Other study ID #: 3-2020-0038
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2, 2020
• Est. completion date: April 1, 2026

Study information

• Verified date: April 2024
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Resectable Pancreatic Cancer

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yona Cho

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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.