ISRCTN56087634Active, not recruitingPhase 2
A multicentre phase II study to investigate the feasibility and safety of high intensity focused ultrasound in the treatment of pancreatic cancer
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- niversity of Oxford
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
- •11. Able to attend for long-term follow-up
- •12. No concurrent malignancy
- •13. No serious medical or psychological condition
- •14. Ability to give fully informed consent
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
Investigators
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