Intraoperative Radiation Therapy for Resectable Pancreatic Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Resectable Pancreatic Cancer

Intervention / Treatment
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* Radiation: intraoperative radiotherapy, IORT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Intervention: intraoperative radiotherapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IORT group<br>Intraoperative radiation therapy of 10 Gy delivered during surgery followed by adjuvant gemcitabine chemotherapy | Radiation: intraoperative radiotherapy, IORT<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic cancer, Intraoperative radiotherapy, neoadjuvant chemotherapy