PanCO
Research type
Research Study
Full title
An open label, single arm pilot study of OncoSil™, administered to study participants with unresectable locally advanced pancreatic adenocarcinoma, given in combination with FOLFIRINOX or gemcitabine+nab-paclitaxel chemotherapies
IRAS ID
219405
Contact name
Paul Ross
Contact email
Sponsor organisation
OncoSil Medical Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 2 months, 1 days
Research summary
Summary of Research
This is a multi-centre, single safety arm study, where 20 participants will be recruited across approximately 8 sites in Australia, United Kingdom and Europe. The primary aim of the study is to investigate the safety of an active implantable medical device OncoSil™ when implanted into patients with pancreatic cancer, who are already receiving chemotherapy.
OncoSil™ is a medical device intended for the use in brachytherapy, a form of radiotherapy where a sealed radiation source is placed (implanted) directly into the tumour to destroy cancer cells. Currently, there is no approved brachytherapy device for the treatment of pancreatic cancer however there is evidence to suggest brachytherapy may have the potential to reduce tumour size and provide symptom relief in patients with advanced pancreatic cancer that cannot be removed with surgery. All participants who have provided written informed consent, will be receive treatment with OncoSil™ plus standard chemotherapy FOLFIRNOX (5-fluorouracil/leucovorin plus oxaliplatin plus irinotecan) or gemcitabine+nab-paclitaxel. Ten participants will be recruited into each chemotherapy arm.
Each participant will be assessed weekly from for 12 weeks and again at 16 weeks and then every 8 weeks until their disease has progressed. Possible side effects and treatments/procedures related to the participant’s cancer will be followed up every 8 weeks for up to 12 months’ post OncoSil™ implantation. Once their disease has progressed, each participant will be followed up every 8 weeks until participant death or until 104 weeks post the last study participant has been enrolled.
Participants will be asked to complete questions to assess their quality of life and pain. Participants will also have additional assessments to assess their level of radiation exposure. Photographs and recordings will also be taken of the tumour and the inside of the stomach during implantation of the OncoSil™.Summary of Results
The safety of the OncoSil™ device and/or implantation procedure was considered satisfactory and acceptable for this study population with unresectable locally advanced pancreatic cancer treated with gemcitabine/nab-paclitaxel or FOLFIRINOX. There were no significant safety concerns or signals, and no unexpected serious toxicities associated with the study device or implantation procedure were identified.Evidence of clinical activity of the study device in terms of durable local disease control was identified by a statistically significant increase of Local Disease Control Rate at 16 weeks over the a priori defined hypothesis of 55%.
Reduction in symptoms (e.g. pain), objective tumour response, CA 19-9 and tumour volume reduction, metabolic tumour response as measured by FDG-PET, and therapeutic signal with respect to overall survival support the probable benefit of the study device.
In addition, 23.8% of the study participants receiving OncoSil™ underwent surgical resection with curative intent, with 80% of these procedures having a R0 margin (no cancer cells seen microscopically at the primary tumour site)
The results of the clinical investigation ONC01P03 (PanCO) support the safety and probable benefit of the OncoSilTM device in combination with standard-of-care chemotherapy for the treatment of suitable patients presenting with locally advanced unresectable pancreatic adenocarcinoma (LAPC) with the potential clinical benefit outweighing the identified risks
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
17/EE/0081
Date of REC Opinion
31 Mar 2017
REC opinion
Further Information Favourable Opinion