ISRCTN56087634
Active, not recruiting
Phase 2
A multicentre phase II study to investigate the feasibility and safety of high intensity focused ultrasound in the treatment of pancreatic cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- ocally advanced pancreatic cancer
- Sponsor
- niversity of Oxford
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Histologically or cytologically confirmed adenocarcinoma
- •2\. Locally advanced inoperable pancreatic ductal adenocarcinoma and or operable pancreatic ductal cancers but patients not fit for surgery
- •3\. A measurable primary tumour on ultrasound imaging, with a target area of less than 8 cm in diameter on CT/MRI
- •4\. A clear 1 cm margin between the tumour and associated organs (duodenum, stomach, transverse colon) on contrast\-enhanced MR imaging
- •5\. Biliary obstruction to be relieved before inclusion in the study
- •6\. Age greater than or equal to 18 years
- •7\. Fit for general anaesthesia
- •8\. Performance status: ECOG \=2
- •9\. An American Society of Anaesthesiologists (ASA) grade of \=3
- •10\. Life expectancy: At least 12 weeks
Exclusion Criteria
- •1\. Patients with TNM Stage IV (metastatic disease)
- •2\. Unclear cancer margins on ultrasound imaging
- •3\. Invasion into the duodenal wall
- •4\. Stricture of superior mesenteric artery directly by tumour encasement, or invasion of SMV below transverse mesocolon
- •5\. Patient suitable for surgical resection
- •6\. Refusal to give informed consent
- •7\. Unable to give informed consent
- •8\. Not fit for HIFU treatment: any significant disease, disorder, or finding which, in the opinion of the investigator, may significantly increase the risk to the patient because of participation in the study
- •9\. Active or ongoing infection requiring IV antibiotics
- •10\. Known pregnancy
Outcomes
Primary Outcomes
Not specified
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