Concurrent FOLFIRINOX Plus High Intensity Focused Ultrasound for Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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)/FOLFIRINOX combined treatment is performed on patients who agree to this study. The combined treatment group is treated in parallel with FOLFIRINOX and HIFU for the first four cycles and then CT is taken for reaction evaluation immediately, 2 months, and 4 months after the four-cycle treatment. For the response assessment, the response rate using RECIST ver. 1.1 and operable rate are evaluated and compared with the results of already established FOLFIRINOX single treatment in the investigators' institute. Time-to-progress and overall survival are calculated.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborators: Focused Ultrasound Foundation; Synex Consulting Ltd
• Treatments: Folfirinox

Criteria

Inclusion Criteria:

All of the following selection criteria must be met before participants can be registered for this clinical trial.

1. Adults over 19-85

2. Persons with a Karnofsky Performance Scale (KPS) of 70 percent or more;

3. A person diagnosed as a tubular adenocarcinoma through biopsy.

4. A person diagnosed with LAPC/BRPC by computed tomography (CT) or magnetic resonance imaging (MRI)

5. A person willing to voluntarily agree to a clinical trial and comply with the test plan

Exclusion Criteria:

The following exclusion criteria may not be registered in clinical trials.

1. The presence of a cystic lesion within pancreatic cancer to be treated with HIFU or at the pancreas adjacent to the pancreatic cancer.

2. The presence of a wide range of scar or surgical clips observed in the passage through the ultrasonic beam.

3. In case proper ultrasound images for HIFU procedures are not shown

4. A person who cannot lie down in a comfortable position.

5. A person who has difficulty communicating

6. A person who has experience in toxic or hypersensitive reactions to FOLFIRINOX anticancer drugs.

7. A person pregnant or breastfeeding

8. Pancreatic cancer patients who have previously been anti-cancer treatment

9. If severe side effects such as aortic rupture, duodenum perforation, gastrointestinal damage or intestinal necrosis are expected due to HIFU procedures.

10. Other cases where participation in this clinical trial is judged inappropriate by the investigator (specific reasons should be recorded in the case report form)