HIFU for pancreatic cancer
Research type
Research Study
Full title
A MULTICENTRE PHASE II STUDY TO INVESTIGATE THE FEASIBILITY AND SAFETY OF HIGH INTENSITY FOCUSED ULTRASOUND IN THE TREATMENT OF PANCREATIC CANCER
IRAS ID
240471
Contact name
Srikanth Reddy
Contact email
Sponsor organisation
CTRG Organisation: University of Oxford / Clinical Trials and Research Governance
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Pancreatic cancer is predicted to become the second commonest cause of death due to cancer. Surgery is feasible in only 15-20% of patients. Life expectancy with metastatic cancer is 5-6 months and 10-12 months for locally advanced inoperable cancers. Many patients with operable disease are not fit for major pancreatic surgery. Although pancreatic cancer has been treated as systemic disease, nearly a third of patients die as a result of local progression rather than systemic spread. Radiotherapy has not yet been shown to prolong life.
High intensity focused ultrasound (HIFU) is a non-invasive way of treating cancers with minimal side effects, low complication rate and quick recovery. Ultrasound waves are used to destroy tumour cells and improvements in technology and experience are enabling complete destruction of tumour. HIFU also releases tumour antigens increasing immune response against cancer. There have been many publications from China showing promise in prolonging life and improving pain control: however this technology needs further evaluation in a Western population.
This study will recruit patients with locally advanced inoperable cancers or operable cancers but who are not fit for major surgery. The study is designed to generate evidence regarding safety and efficacy, in order to power further studies. 20 patients will be recruited over 24 months. HIFU treatment will be delivered under general anaesthesia or sedation and patients discharged home within 72 hours. Short-term outcome measures include feasibility, safety & the completeness of destruction of the tumour. Long-term outcome measures include overall survival, recurrence, quality of life (including pain) and evidence of immune response against cancers.
If the results of this study are positive, a multi-centre randomised controlled trial will be planned. Future studies will include a combination of HIFU with immunotherapy and/or targeted drug delivery.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
19/SC/0095
Date of REC Opinion
5 Jun 2019
REC opinion
Further Information Favourable Opinion