Resectable Pancreatic Cancer
Conditions
Keywords
Pancreatic cancer, Intraoperative radiotherapy, neoadjuvant chemotherapy
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.
Interventions
RADIATIONintraoperative 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.
Sponsors
Yona Cho
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Intervention: intraoperative radiotherapy
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
South Korea
Outcome results
None listed