Trials / Active Not Recruiting
Active Not RecruitingNCT05466799
FOLFIRINOX Versus OncoSil™ in Addition to FOLFIRINOX in Patients With Locally Advanced Pancreatic Adenocarcinoma
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.
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 88 (actual)
- Sponsor
- OncoSil Medical Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FOLFIRINOX chemotherapy | Standard Of Care Chemotherapy regimen for treatment of Locally Advanced Pancreatic cancer |
| DEVICE | OncoSil™ | Implantation of OncoSil 32P microparticles into the Pancreatic Tumour under EUS guidance |
Timeline
- Start date
- 2023-04-26
- Primary completion
- 2026-01-26
- Completion
- 2027-07-01
- First posted
- 2022-07-20
- Last updated
- 2026-02-13
Locations
14 sites across 5 countries: Australia, Belgium, Italy, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT05466799. Inclusion in this directory is not an endorsement.