Concurrent FOLFIRINOX Plus High Intensity Focused Ultrasound for Pancreatic Cancer (NCT05262452) | Clinical Trial Compass
UnknownNot Applicable
Concurrent FOLFIRINOX Plus High Intensity Focused Ultrasound for Pancreatic Cancer
South Korea60 participantsStarted 2021-08-09
Plain-language 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.
Who can participate
Age range19 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
✕
What they're measuring
1
2-month Tumor Response
Timeframe: immediately after the completion of the four-cycle combined treatment (each cycle is 14 days)
2
4-month Tumor Response
Timeframe: 4 months after the start of combined treatment
3
6-month Tumor Response
Timeframe: 6 months after the start of combined treatment
4
Percentage of subjects that were subject to surgical resection
Timeframe: 4 months or 6 months after the start of the combined treatment