Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Radiation: Preoperative Stereotactic body radiation therapy (SBRT), Pancreatic resection, Adjuvant Chemotherapy
- Registration Number
- NCT05679583
- Lead Sponsor
- Yonsei University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Preoperative SBRT arm Preoperative Stereotactic body radiation therapy (SBRT), Pancreatic resection, Adjuvant Chemotherapy Patients with resectable pancreatic cancer will receive preoperative SBRT 2 to 4 weeks before surgery. And 4 weeks after surgery, adjuvant CTx will be administered for 6 months.
- Primary Outcome Measures
Name Time Method R0 rate 2 weeks after the surgical resection R0 resection is defined as the resection margin more than 1 mm away from the tumor on histological findings after pancreatic cancer surgery. The R0 rate refers to the proportion of patients showing R0 resection, based on all patients.
- Secondary Outcome Measures
Name Time Method Local control rate Patient follow-up will be performed 3 months after the surgery and then at 6-month intervals thereafter. Follow-up will be conducted for a total of 2 years. Local control rate It is based on the time from the date when pancreatic cancer was first diagnosed histologically to the time when local recurrence was confirmed on clinical and radiological examination.
Tumor recurrence Patient follow-up will be performed 3 months after the surgery and then at 6-month intervals thereafter. Follow-up will be conducted for a total of 2 years. Tumor recurrence Imaging tests and tumor marker tests are performed every 3-6 months after treatment to determine the presence or absence of tumor recurrence.
Quality of life (based on EORTC QLQ-C30) Patient follow-up will be performed 3 months after the surgery and then at 6-month intervals thereafter. Follow-up will be conducted for a total of 2 years. Quality of life (based on EORTC QLQ-C30) Before the start of treatment, immediately after completion, 3 months after treatment, and every 6 months until 2 years thereafter.
Disease-free survival Patient follow-up will be performed 3 months after the surgery and then at 6-month intervals thereafter. Follow-up will be conducted for a total of 2 years. Disease-free survival It is based on the time from the date when pancreatic cancer was first diagnosed histologically to the time when recurrence was confirmed on clinical or radiological examination or when the subject died.
Quality of life (based on FACT-Hep) Patient follow-up will be performed 3 months after the surgery and then at 6-month intervals thereafter. Follow-up will be conducted for a total of 2 years. Quality of life (based on FACT-Hep) Before the start of treatment, immediately after completion, 3 months after treatment, and every 6 months until 2 years thereafter.
Treatment related acute/chronic toxicity (based on CTCAE ver 5.0) Patient follow-up will be performed 3 months after the surgery and then at 6-month intervals thereafter. Follow-up will be conducted for a total of 2 years. Treatment related acute/chronic toxicity (based on CTCAE ver 5.0) During treatment, immediately after the end of treatment, 3 months after treatment, and at 6-month intervals thereafter, CTCAE 5.0 is measured.
Overall survival rate Patient follow-up will be performed 3 months after the surgery and then at 6-month intervals thereafter. Follow-up will be conducted for a total of 2 years. Overall survival rate It is based on the date from the date of the first histological diagnosis of pancreatic cancer to the date of death of the subject or the date of the last follow-up.
Trial Locations
- Locations (1)
Yonsei University Health System, Severance Hospital
🇰🇷Seoul, Korea, Republic of