TRIPP-FFX
Research type
Research Study
Full title
An open-label, multi-centre, randomized study of TaRgeted Intratumoural Placement of Phosphorous-32 (OncoSil™) in addition to FOLFIRINOX chemotherapy versus FOLFIRINOX chemotherapy alone in patients with unresectable locally advanced pancreatic adenocarcinoma.
IRAS ID
316753
Contact name
Paul Ross
Contact email
Sponsor organisation
OncoSil Medical Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 1 days
Research summary
This is a multi-centre, open-label, randomized clinical investigation that will recruit 80 patients approximately 15 sites in Australia, the United Kingdom and the EU over a 2 year period. The purpose of the investigation is to evaluate the safety and efficacy of an active implantable medical device called OncoSil™, when applied to patients with pancreatic cancer who are treated with FOLFIRINOX chemotherapy. The OncoSil™ is CE mark medical device approved for use in the treatment for unresectable (unable to surgically remove), locally advanced pancreatic cancer in combination with gemcitabine-based chemotherapy. For this study OncoSil will be used in addition to another standard chemotherapy regimen called FOLFIRINOX. The subjects will receive FOLFIRINOX chemotherapy alone or FOLFIRINOX chemotherapy plus OncoSil™. This is a randomized clinical study. Per 1:1 randomization, study subjects will be allocated to receive a planned number of 12 cycles of FOLFIRINOX chemotherapy or OncoSil™ (40 subjects) in addition to a scheduled 12 cycles of FOLFIRINOX chemotherapy (40 subjects). Before randomisation, the investigator will indicate whether the study subject will be treated with full-dose FOLFIRINOX or the modified FOLFIRINOX regimen (mFOLFIRINOX).
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
22/YH/0254
Date of REC Opinion
6 Dec 2022
REC opinion
Further Information Favourable Opinion