Locally advanced pancreatic cancer Cancer Malignant neoplasm of pancreas
Conditions
Interventions
Patients with confirmed pancreatic cancer (with or without spread to other organs) who cannot be treated with surgery can participate in the trial. Participants will undergo an MRI scan to determine i
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of HIFU therapy for pancreatic cancer measured using 30-day survival & adverse events and serious adverse events recorded using Clavien-Dindo grading | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility of HIFU therapy : 1. Number of eligible patients agreeing to participate & proportion of enrolled participants completing treatment and follow up 2. Patient survival at 30 days, 3, 6 and 12 months 3. Treatment effect of HIFU on pancreatic cancer assessed using radiological evidence of tumour ablation on MRI at 30 days 4. Progression-free patient survival Imaging at 3, 6 and 12 months post-treatment or as indicated clinically 5. Immunological effects of HIFU treatment by regular measurement of leukocyte subsets at baseline, 14 days, 30 days and 3 months 6. Systemic response to HIFU treatment by regular measurement of CA 19-9 at baseline, 30 days, 3, 6 and 12 months 7. Patient experience of HIFU treatment using a questionnaire recording different aspects of patient experience during HIFU treatment admission at 2 weeks and 3 months following treatment 8. Patient-reported quality of life following HIFU treatment: ED-5D, EORTC QLQ-C30 and EORTC QLQ-PAN26 will be recorded at baseline, 72 hours, 30 days, 3, 6 and 12 months 9. Pain scores using Brief pain inventory at Baseline, 72 hours, 14 & 30 days, 3, 6 and 12 months | — |
Countries
England, United Kingdom
Contacts
Public ContactKatherine Gordon-Quayle
Outcome results
None listed