KCT0006302
Not yet recruiting
未知
Evaluation of therapeutic efficacy and safety of concurrent FOLFIRINOX plus high intensity focused ultrasound (ALPIUS 900) for locally advanced/borderline resectable pancreatic cancer: A prospective single-center, single-arm, investigator-initiated, open-labeled, exploratory clinical trial
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Seoul National University Hospital
- Enrollment
- 60
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
- •\- Diagnosis results based on CT or MRI taken at the hospital where pancreatic cancer was first diagnosed or being treated are recognized as valid. However, only the results obtained within 4 weeks from the screening date are accepted.
- •\- LAPC/BRPC is determined by investigators based on the American Point Committee on Cancer (AJCC) guidelines (see table below).
- •T1 Tumor diameter \< 2cm
- •T22cm \= tumor diameter \= 4cm
- •T3Tumor diameter \> 4cm
- •T4Invasion of the celiac trunk, the superior mesenteric artery, and proper hepatic artery, regardless of tumor size.
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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