Status:
UNKNOWN
Concurrent FOLFIRINOX Plus High Intensity Focused Ultrasound for Pancreatic Cancer
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Focused Ultrasound Foundation
Synex Consulting Ltd
Conditions:
Pancreatic Cancer Non-resectable
Chemotherapy Effect
Eligibility:
All Genders
19-85 years
Phase:
NA
Brief Summary
In patients diagnosed with locally advanced pancreatic cancer (LAPC)/borderline resectable pancreatic cancer (BRPC) and planned chemotherapy using FOLFIRINOX, high intensity focused ultrasound (HIFU)/...
Detailed Description
Patients diagnosed with pancreatic cancer through biopsy and diagnosed with LAPC/BRPC through computed tomography (CT) or magnetic resonance imaging (MRI) are referred to this clinical trial. When the...
Eligibility Criteria
Inclusion
- All of the following selection criteria must be met before participants can be registered for this clinical trial.
- Adults over 19-85
- Persons with a Karnofsky Performance Scale (KPS) of 70 percent or more;
- A person diagnosed as a tubular adenocarcinoma through biopsy.
- A person diagnosed with LAPC/BRPC by computed tomography (CT) or magnetic resonance imaging (MRI)
- A person willing to voluntarily agree to a clinical trial and comply with the test plan
Exclusion
- The following exclusion criteria may not be registered in clinical trials.
- The presence of a cystic lesion within pancreatic cancer to be treated with HIFU or at the pancreas adjacent to the pancreatic cancer.
- The presence of a wide range of scar or surgical clips observed in the passage through the ultrasonic beam.
- In case proper ultrasound images for HIFU procedures are not shown
- A person who cannot lie down in a comfortable position.
- A person who has difficulty communicating
- A person who has experience in toxic or hypersensitive reactions to FOLFIRINOX anticancer drugs.
- A person pregnant or breastfeeding
- Pancreatic cancer patients who have previously been anti-cancer treatment
- If severe side effects such as aortic rupture, duodenum perforation, gastrointestinal damage or intestinal necrosis are expected due to HIFU procedures.
- Other cases where participation in this clinical trial is judged inappropriate by the investigator (specific reasons should be recorded in the case report form)
Key Trial Info
Start Date :
August 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05262452
Start Date
August 9 2021
End Date
December 1 2024
Last Update
October 26 2022
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 03080