Intraoperative Radiation Therapy for Resectable Pancreatic Cancer

Not Applicable

Active, not recruiting

• Conditions: Resectable Pancreatic Cancer
• Interventions: Radiation: intraoperative radiotherapy, IORT

• Registration Number: NCT05181488
• Lead Sponsor: Yona Cho

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-02
• Study First Submitted: 2021-12-05
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-15
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IORT group	intraoperative radiotherapy, IORT	Intraoperative radiation therapy of 10 Gy delivered during surgery followed by adjuvant gemcitabine chemotherapy

Primary Outcome Measures

Name	Time	Method
3-year local recurrence rate	3 year after intraoperative radiotherapy	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.

Secondary Outcome Measures

Name	Time	Method
disease free survival	1 year and 2 year after intraoperative radiotherapy.	Disease-free survival is defined as the time from intraoperative radiotherapy to recurrence of tumor, death or last patient contact.
Overall survival	1 year and 2 year after intraoperative radiotherapy.	Overall survival was defined as the time from intraoperative radiotherapy to death or last patient contact.
post-operative complication	3 year after intraoperative radiotherapy	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.

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of