Actively Recruiting
Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer
Led by Yonsei University · Updated on 2023-01-11
25
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Pancreatic cancer is a cancer with a poor prognosis and a high mortality rate. The prognosis of surgically resectable pancreatic cancer is better than that of unresectable pancreatic cancer. But the prognosis is still poor enough to report a 2-year disease-free survival rate of 47.0% despite the application of standard treatment. Preoperative chemotherapy or radiotherapy for pancreatic cancer has been performed for a long time, especially for locally advanced pancreatic cancer. However, there are very few studies on the application of preoperative chemotherapy or radiotherapy for borderline resectable or resectable pancreatic cancer. The PREOPANC trial is a representative randomized study to investigate the effect of preoperative chemo/radiation therapy in borderline resectable or resectable pancreatic cancer. As a result, the overall survival, progression-free survival, local control, and distant control rates were significantly superior in preoperative therapy group. However, when only patients with resectable pancreatic cancer were analyzed separately, there was no significant difference in overall survival rate or complete resection rate. In 2020, retrospective propensity score matching analysis using the national cancer database revealed that the addition of preoperative stereotactic body radiation therapy (SBRT) showed a significant increase in overall survival rate rather than preoperative chemotherapy alone. In addition, SBRT also showed a significant increase in overall survival rather than conventional fractionated RT. In summary, the current standard treatment for resectable pancreatic cancer is surgical resection, but a higher survival rate can be expected when preoperative therapy is added. However, there is no study that focused on the role of preoperative SBRT. Therefore, this study aims to confirm the effectiveness of adding preoperative SBRT alone in resectable pancreatic cancer.
CONDITIONS
Official Title
Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically diagnosed adenocarcinoma of the pancreas
- Resectable pancreatic cancer at the time of diagnosis, defined as: tumor not involving the superior mesenteric vein or portal vein beyond 180�, no involvement of the superior mesenteric artery, celiac artery, or common hepatic artery, and no distant metastases
- Age 20 years or older at diagnosis
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Voluntary participation with signed informed consent
You will not qualify if you...
- History of radiation exposure to the abdomen
- Pancreatic cancer that cannot be surgically removed
- Presence of distant metastasis
- Current condition preventing surgery based on general performance status, bone marrow, or kidney function
- Active or uncontrolled infection
- Uncontrolled heart disease
- Pregnant or breastfeeding women
- History of malignant tumors except skin epithelial carcinoma (excluding malignant melanoma), stage 0 cervical cancer, and early thyroid cancer
- Patients previously treated for malignant tumors and cured for more than 5 years are eligible
AI-Screening
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Trial Site Locations
Total: 1 location
1
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
I
Ik Jae Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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