Ignite Creation Date:
2024-05-06 @ 6:28 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05679583
Status:
RECRUITING
Last Update Posted:
2023-01-11
First Post:
2022-12-25
Brief Title:
Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer A Prospective Phase II Study
Status:
RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 470 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 chemoradiation 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None