Ignite Creation Date:
2024-05-06 @ 10:29 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03273374
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2017-09-03
Brief Title:
Intraoperative Radiation Therapy for Resectable Pancreatic Cancer
Sponsor:
Gangnam Severance Hospital
Organization:
Gangnam Severance Hospital
Study Overview
Official Title:
A Prospective Phase II Study Investigating Efficacy of Intraoperative Radiation Therapy for Resectable Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2023-09
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:
This phase II study is designed to investigate the efficacy of IORT for patients with resectable pancreatic adenocarcinoma The purpose of the study is to show the local recurrence rate after surgical resection and IORT is superior to that of surgical resection alone from the historical control A total of 42 patients will be enrolled and these patients will receive IORT of 10 Gy at 5 millimeter depth of the tumor bed followed by 6 cycles of adjuvant gemcitabine chemotherapy
Detailed Description:
Treatment outcomes of pancreatic cancer are poor even after surgical resection thus patients may receive adjuvant chemotherapy or chemoradiotherapy Intraoperative radiotherapy IORT with low energy 50 kV x-ray allows delivery of a high dose radiation to the tumor bed during surgery while effectively sparing adjacent critical organs Another advantage of IORT is that delivery of IORT does not interfere with the scheduled administration of adjuvant chemotherapy or chemoradiotherapy Here we investigate the efficacy of IORT for patients with resectable pancreatic adenocarcinoma by comparing the local recurrence rate after surical resection and IORT with that of surgical resection alone from the historical control A total of 42 patients will be enrolled in this phase II trial and these patients will receive IORT of 10 Gy at 5 millimeter depth of the tumor bed followed by 6 cycles of adjuvant gemcitabine chemotherapy
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