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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000906358
Ethics application status
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Approved
Date submitted
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1/07/2026
Date registered
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23/07/2026
Date last updated
Help: Date last updated
23/07/2026
Date data sharing statement initially provided
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23/07/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
A study of chemotherapy with or without OncoSil™ targeted radiation treatment for people with locally advanced pancreatic cancer
Scientific title
Impact of combined chemotherapy and 32P implantation on clinical outcomes in patients with locally advanced pancreatic adenocarcinoma: a randomized controlled trial
Additional trial identifiers [1] 317765 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Unresectable Locally Advanced Pancreatic Adenocarcinoma 342666 0
Condition category
Condition code
Cancer 338801 338801 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The substance being investigated for the project is an active implantable (radiological) medical device called OncoSil, which contains the active treatment “radioactive Phosphorus (32-P)” inside inactive silicon particles. These particles are tiny, and range in size from 28 to 32 micrometres, which is smaller than the width of a human hair (which typically ranges in width from 40 to 120 micrometres). The study involves exposure to an amount of ionising radiation in the form of a 32-P implant which is intended to deliver an average absorbed radiation dose per treated tumour of 100 Gy (± 20%). The number of particles inserted into the tumour will range from 120 thousand to 2 million, depending on the dose required per patient.

An endoscopic ultrasound (EUS) will be used to implant the particles, allowing the endoscopist to view the pancreas and insert the particles via a fine needle. An endoscope will be guided down the oesophagus, through the stomach and into the first part of the small intestine. The ultrasound is used to image the tumour in the pancreas. A fine needle is extended from the end of the endoscope into the pancreas and into the middle of the tumour. Once this needle is in an appropriate position within the tumour, a doctor will attach a syringe filled with OncoSil to the other end of the needle. The doctor will slowly depress the plunger of the syringe so that the contents of the syringe are implanted into the tumour, the OncoSil syringe is removed. Another syringe contain a small amount of saline is attached to the needle. This will flush any remaining OncoSil from the needle into the tumour. The saline syringe is removed. The endoscope is removed by carefully pulling it back up the oesophagus and out the participants mouth.
The implantation procedure will only occur once, as soon as clinically possible in the 2nd week of the 2nd cycle of FOLFIRINOX chemotherapy. Implantation will occur between the 2nd and 3rd cycle, ensuring there is no delay or change to a participants chemotherapy schedule. The implantation procedure via EUS procedure will go for approx. 20-40 minutes.

The dose of OncoSil will be calculated prior to the procedure to achieve an Implanted Volume/Tumour Volume of 8% to deliver a dose of 100Gy to the tumour mass. Standard of care diagnostic imaging pre-chemotherapy will be accessed to assist with dose calculations, and on the day of the procedure the dose can be adjusted if the endoscopist determines if the tumour volume has increased/decreased since prior tumour volume assessment.

Intervention fidelity will be assessed through review of medical records, procedural reports, and treatment records. OncoSil implantation details will be documented by the treating endoscopist/investigator. Post-implantation Bremsstrahlung SPECT/CT imaging will be performed same day to confirm localisation of implanted OncoSil. The participants adherence to chemotherapy schedules will be assessed through review of chemotherapy administration records.
Intervention code [1] 334605 0
Treatment: Devices
Description of the comparator or control
'Standard-of-care chemotherapy ONLY" group is the comparator.

The drug to be administered will be FOLFIRINOX:
FOL – calcium folinate,
F – fluorouracil (5FU),
IRIN – irinotecan,
OX – oxaliplatin),

The typical, recommended dose for FOLFIRINOX regime is intravenous infusion of FOL 400 mg/m2, F 400 mg/m2, IRIN 180 mg/m2, and OX 85 mg/m2, administered on Day 1 and for about 2-4 hours, followed by continuous infusion of additional 2,400 mg/m2 of F over 46 hours, of each 14-day cycle.

Cycle schedules are continuous until disease progression or unacceptable toxicity. The amount, duration, and frequency administered will vary and will be the discretion of a participant's Oncologist, and will will be the same whether a participant is in the study or not.
Control group
Active

Outcomes
Primary outcome [1] 346003 0
Overall Survival
Timepoint [1] 346003 0
From baseline until death from any cause, last follow-up, or study completion (up to Week 104)
Secondary outcome [1] 464110 0
Change to Tumour stage
Timepoint [1] 464110 0
Baseline, Weeks 12, 24, 52, 104, and prior to surgical assessment
Secondary outcome [2] 464112 0
Surgical Resection Rate
Timepoint [2] 464112 0
Assessed continuously following treatment initiation; formally reviewed at Weeks 12, 24, 52, 104
Secondary outcome [3] 464115 0
R0 Resection Rate
Timepoint [3] 464115 0
At time of surgical resection
Secondary outcome [4] 464116 0
Progression-free Survival
Timepoint [4] 464116 0
Baseline, and at Weeks 12, 24, 52, and 104 or until disease progression or death
Secondary outcome [5] 464119 0
Adverse Events
Timepoint [5] 464119 0
From baseline to Week 104 (continuous monitoring with formal review at Weeks 12, 24, 52, 104)
Secondary outcome [6] 464120 0
Quality of Life
Timepoint [6] 464120 0
Baseline, Weeks 12, 24, 52, and 104

Eligibility
Key inclusion criteria
- Histologically or cytologically proven adenocarcinoma of the pancreas
- Unresectable locally advanced pancreatic adenocarcinoma as per National Comprehensive Cancer Network (NCCN) guidelines (MDT review of imaging)
- Considered fit to commence first-line standard FOLFIRINOX therapy
- Able to provide informed consent
- Life expectancy at least 3 months (as assessed by investigator)
- An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- Willing and able to complete study procedures within the study timelines.
- Provide signed Informed Consent.
- Technically feasible – tumour must be within reach of the EUS probe for fine needle injection.
- Standard first line chemotherapy with FOLFIRINOX will be commenced within 14 days post enrolment, with OncoSilTM implantation to occur during the 4th week from commencement of chemotherapy.
- Provide signed informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
- Evidence of metastatic disease
- More than one pancreatic tumour lesion
- Any prior radiotherapy or chemotherapy for pancreatic cancer
- Use of other investigational agent at the time of screening, or within 30 days or five half-lives of Screening Visit, whichever is longer
- Pregnant or lactating
- Known history of hypersensitivity to silicon or phosphorus
- In the opinion of the investigator, EUS directed implantation posing undue study participant risk. This includes:
a) Where previous EUS-FNA was considered technically too difficult to perform due to anatomy/vessels/varices
b) Imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumour within the pancreas
c) Presence (or significant risk) of varices near to the target tumour.
(Note: The feasibility of implantation of the target tumour and assessment of risk can be conducted at any time between screening and the implantation date. A study participant should be considered for withdrawal prior to and including at the time of OncoSil™ treatment, if any of the above risk features become apparent following participant screening)
- Patients who do not consent to chemotherapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central Randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
228
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 322303 0
Hospital
Name [1] 322303 0
Royal Adelaide Hospital
Country [1] 322303 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Country
Australia
Secondary sponsor category [1] 325222 0
Commercial sector/Industry
Name [1] 325222 0
OncoSil Medical Ltd
Address [1] 325222 0
Country [1] 325222 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320813 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 320813 0
Ethics committee country [1] 320813 0
Australia
Date submitted for ethics approval [1] 320813 0
31/03/2026
Approval date [1] 320813 0
30/06/2026
Ethics approval number [1] 320813 0
2026/HRE00024

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 151726 0
Prof Nam Nguyen
Address 151726 0
Department of Gastroenterology, Royal Adelaide Hospital, Port Road, Adelaide SA 5000
Country 151726 0
Australia
Phone 151726 0
+61 8 70742142
Fax 151726 0
Email 151726 0
[email protected]
Contact person for public queries
Name 151727 0
Joshua Zobel
Address 151727 0
Department of Gastroenterology, Royal Adelaide Hospital, Port Road, Adelaide SA 5000
Country 151727 0
Australia
Phone 151727 0
+61 8 70742188
Fax 151727 0
Email 151727 0
[email protected]
Contact person for scientific queries
Name 151728 0
Joshua Zobel
Address 151728 0
Department of Gastroenterology, Royal Adelaide Hospital, Port Road, Adelaide SA 5000
Country 151728 0
Australia
Phone 151728 0
+61 8 70742188
Fax 151728 0
Email 151728 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.