Spots Global Cancer Trial Database for FOLFIRINOX Versus OncoSil™ in Addition to FOLFIRINOX in Patients With Locally Advanced Pancreatic Adenocarcinoma
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: FOLFIRINOX Versus OncoSil™ in Addition to FOLFIRINOX in Patients With Locally Advanced Pancreatic Adenocarcinoma
Official Title: An Open-label, Multi-centre, Randomized Study of TaRgeted Intratumoural Placement of P-32 (OncoSil™) in Addition to FOLFIRINOX Chemotherapy vs FOLFIRINOX Alone in Patients With Unresectable Locally Advanced Pancreatic Adenocarcinoma.
Study ID: NCT05466799
Conditions
Study Description
Brief Summary: The purpose of the study is to assess the safety and efficacy of OncoSil™ when given in addition to standard FOLFIRINOX chemotherapy for treatment of Locally Advanced Pancreatic Cancer
Detailed Description: Patients with Locally Advanced Pancreatic Cancer who have not received prior treatment to their pancreatic cancer will be informed about the study and the potential risks and benefits. After providing informed consent patients will undergo a 3 week screening period to confirm eligibility for the study. Patients who meet all eligibility criteria will be randomised 1:1 to either the control arm of up to 12 cycles of standard of care FOLFIRINOX chemotherapy or implantation of OncoSil™ in addition to the same FOLFIRINOX chemotherapy regimen. Patients will be followed for side side effects and palliative benefits during 4-8 weekly study visits and the objective efficacy of the treatment will be assessed by CT scans every 8 weeks. Quality of Life will be measured on various time-points using questionnaires.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Epworth Healthcare, Richmond, Victoria, Australia
AZ Maria Middelares, Ghent, , Belgium
San Camillo Forlanini, Rome, , Italy
Azienda Ospedaliera Universitaria Integrata Verona, Verona, , Italy
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Universitario 12 de Octobre, Madrid, , Spain
Hospital Universitario de Fuenlabrada, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Clínica Universidad de Navarra, Pamplona, , Spain
Guy's Hospital, London, , United Kingdom
Imperial College, London, , United Kingdom
The Christie Hospital/Manchester Royal Infirmary, Manchester, , United Kingdom
Freeman Hospital, Newcastle Upon Tyne, , United Kingdom
University Hospital Southampton, Southampton, , United Kingdom
Contact Details
Name: Michele Milella, MD, PhD
Affiliation: University Hospital of Verona
Role: PRINCIPAL_INVESTIGATOR
Name: Giuseppe Malleo, MD, PhD
Affiliation: University Hospital of Verona
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
