PanDox: Targeted Doxorubicin in Pancreatic tumours
Research type
Research Study
Full title
PanDox: Feasibility of Enhanced Chemotherapy Delivery to non-resectable Primary Pancreatic Tumours Using Thermosensitive Liposomal Doxorubicin (ThermoDox®) and Focused Ultrasound
IRAS ID
272253
Contact name
Mark Middleton
Contact email
Sponsor organisation
University of Oxford
Eudract number
2019-003950-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 31 days
Research summary
PanDox: Feasibility of Enhanced Chemotherapy Delivery to non-resectable Primary Pancreatic Tumours Using Thermosensitive Liposomal Doxorubicin (ThermoDox®) and Focused Ultrasound
Chemotherapy remains the current treatment for patients with metastatic pancreatic cancer, but delivery is hindered by protein layers around cancer cells, limiting response. We will investigate ways of improving drug transport to cancer cells, in order to improve patient outcomes.
Ultrasound is a currently available, non-invasive, safe and low cost way of imaging tumours. Focused ultrasound can be used to generate gentle heating in localised areas, approximately the size of a grain of rice. Chemotherapy drugs such as doxorubicin can be coated with a heat-sensitive layer, so that the active drug is only released when a specific temperature is reached, and at the target location which has been heated.
This study combines focused ultrasound to generate heat, and a heat-sensitive chemotherapy drug (ThermoDox®), delivered into the blood. This is compared to the standard delivery of chemotherapy – the drug given into the bloodstream without the addition of ultrasound. A good way to understand how a drug can affect cancer cells is to take samples of cancer tissue (called biopsies). By taking a biopsy of the pancreas tumour after treatment, we can assess the effects of these two delivery approaches.
If this study shows that focused ultrasound can be delivered safely to improve the amount of drug delivered to pancreas tumours, then it would allow future trials to be carried out in patients with pancreatic cancer that use different drug therapies with ultrasound. We hope this will result in an improved response to chemotherapy for patients.
The trial is to be performed in Oxford University NHS Foundation Trust and is sponsored by the University of Oxford. We plan to recruit 18 patients within 12 months; individual patients each being in the trial for 6 weeks.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
20/EE/0284
Date of REC Opinion
18 Jan 2021
REC opinion
Further Information Favourable Opinion