Back to resultsIntraoperative Radiation Therapy for Resectable Pancreatic Cancer
Primary Purpose
Resectable Pancreatic Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
intraoperative radiotherapy, IORT
Sponsored by
About this trial
This is an interventional treatment trial for Resectable Pancreatic Cancer focused on measuring Pancreatic cancer, Intraoperative radiotherapy, neoadjuvant chemotherapy
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
Sites / Locations
- Gangnam Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IORT group
Arm Description
Intraoperative radiation therapy of 10 Gy delivered during surgery followed by adjuvant gemcitabine chemotherapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
disease free survival
Disease-free survival is defined as the time from intraoperative radiotherapy to recurrence of tumor, death or last patient contact.
Overall survival
Overall survival was defined as the time from intraoperative radiotherapy to death or last patient contact.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05181488
Brief Title
Intraoperative Radiation Therapy for Resectable Pancreatic Cancer
Official Title
A Prospective, Phase II Study Evaluating the Efficacy of Intraoperative Radiotherapy After Neoadjuvant Chemotherapy in Patients With Resectable Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2, 2020 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yona Cho
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resectable Pancreatic Cancer
Keywords
Pancreatic cancer, Intraoperative radiotherapy, neoadjuvant chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Intervention: intraoperative radiotherapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IORT group
Arm Type
Experimental
Arm Description
Intraoperative radiation therapy of 10 Gy delivered during surgery followed by adjuvant gemcitabine chemotherapy
Intervention Type
Radiation
Intervention Name(s)
intraoperative radiotherapy, IORT
Intervention Description
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.
Primary Outcome Measure Information:
Title
3-year local recurrence rate
Description
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.
Time Frame
3 year after intraoperative radiotherapy
Secondary Outcome Measure Information:
Title
post-operative complication
Description
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.
Time Frame
3 year after intraoperative radiotherapy
Title
disease free survival
Description
Disease-free survival is defined as the time from intraoperative radiotherapy to recurrence of tumor, death or last patient contact.
Time Frame
1 year and 2 year after intraoperative radiotherapy.
Title
Overall survival
Description
Overall survival was defined as the time from intraoperative radiotherapy to death or last patient contact.
Time Frame
1 year and 2 year after intraoperative radiotherapy.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yona Cho
Phone
82-2-2019-4601
Email
IAMYONA@yuhs.ac
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yona Cho
Phone
82-2-2019-4601
Email
IAMYONA@yuhs.ac
12. IPD Sharing Statement
Learn more about this trial
Intraoperative Radiation Therapy for Resectable Pancreatic Cancer
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