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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05466799




Registration number
NCT05466799
Ethics application status
Date submitted
12/07/2022
Date registered
20/07/2022

Titles & IDs
Public title
FOLFIRINOX Versus OncoSil™ in Addition to FOLFIRINOX in Patients With Locally Advanced Pancreatic Adenocarcinoma
Scientific 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.
Secondary ID [1] 0 0
ONCO01P04
Universal Trial Number (UTN)
Trial acronym
TRIPP-FFX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced Pancreatic Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - FOLFIRINOX chemotherapy
Treatment: Devices - OncoSil™

Active comparator: FOLFIRINOX Chemotherapy - Subjects in Arm A will receive up to 12 cycles of Standard Of Care FOLFIRINOX chemotherapy

Experimental: OncoSil™ in addition to FOLFIRINOX Chemotherapy - Subjects in Arm B will be implanted with the OncoSil™ device in addition to up to 12 cycles of Standard Of Care FOLFIRINOX chemotherapy


Treatment: Drugs: FOLFIRINOX chemotherapy
Standard Of Care Chemotherapy regimen for treatment of Locally Advanced Pancreatic cancer

Treatment: Devices: OncoSil™
Implantation of OncoSil 32P microparticles into the Pancreatic Tumour under EUS guidance
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability
Timepoint [1] 0 0
Through study completion, an average of 18 months
Primary outcome [2] 0 0
Local Disease Control Rate (LDCR) at 16 Weeks
Timepoint [2] 0 0
16 weeks after initiation of FOLFOX chemotherapy
Secondary outcome [1] 0 0
Local Progression Free Survival (LPFS), within the pancreas
Timepoint [1] 0 0
From date of enrolment until the date of first documented local progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient
Secondary outcome [2] 0 0
Progression Free Survival
Timepoint [2] 0 0
From date of enrolment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient
Secondary outcome [3] 0 0
Time to symptomatic progression
Timepoint [3] 0 0
From date of enrolment until the date of symptomatic progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient
Secondary outcome [4] 0 0
Clinical Benefit Response
Timepoint [4] 0 0
From date of enrolment until the date of first documented local progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient
Secondary outcome [5] 0 0
CA 19-9 response
Timepoint [5] 0 0
From date of enrolment until the date of first documented local progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient
Secondary outcome [6] 0 0
Overall Survival
Timepoint [6] 0 0
Through study completion, an average of 18 months
Secondary outcome [7] 0 0
Patient Reported Outcomes
Timepoint [7] 0 0
Through study completion, an average of 18 months
Secondary outcome [8] 0 0
Pain Scores
Timepoint [8] 0 0
From date of enrolment until the date of first documented local progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient
Secondary outcome [9] 0 0
Weight loss
Timepoint [9] 0 0
From date of enrolment until the date of first documented local progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient
Secondary outcome [10] 0 0
Tumour response
Timepoint [10] 0 0
From date of enrolment until the date of first documented local progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient
Secondary outcome [11] 0 0
Surgical resection rate
Timepoint [11] 0 0
Through study completion, an average of 18 months
Secondary outcome [12] 0 0
Target Tumour Volumetric Change
Timepoint [12] 0 0
From date of enrolment until the date of first documented local progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient

Eligibility
Key inclusion criteria
1. Histologically or cytologically proven adenocarcinoma of the pancreas.
2. Unresectable locally advanced pancreatic adenocarcinoma according to NCCN 2021 guidelines.Staging and unresectability must be confirmed by central review of the baseline CT scan.
3. Pancreatic target tumour diameter of < 7.0 cm (longest axis), as qualified by the central reading centre.
4. Karnofsky Performance Status = 70
5. = 18 years of age at screening.
6. Considered fit to commence first-line standard FOLFIRINOX chemotherapy:

i) Adequate renal function: serum creatinine less than 1.5 x upper limit of normal (ULN).

ii) Adequate liver function: serum liver transaminases = 3 x ULN and serum bilirubin = 1.5 x ULN*.

*For study participants with recent biliary obstruction treated by drainage (e.g. stent), serum bilirubin of > 1.5 x ULN will be accepted for study entry provided that serial levels demonstrate clear improvement. In addition, chemotherapy should not be commenced until serum bilirubin is = 1.5 x ULN.

iii) Adequate bone marrow function: white blood cells (WBCs) = 3,000/mm3, absolute neutrophil count (ANC) = 1,500/mm3, haemoglobin = 9 g/dL, and platelets = 100,000/mm3 iv) UGT1A1 polymorphism and DPD deficiency test performed and dose reductions applied as per local institutional practice.
7. Provide signed Informed Consent.
8. Willing and able to complete study procedures within the study timelines.
9. Life expectancy of at least 3 months at the time of screening as judged by the investigator.
10. Treated with or eligible to commence prophylactic treatment with a proton-pump inhibitor prior to implantation, and to continue to receive treatment for at least 6 months post implantation.
11. Not pregnant, and if of childbearing potential, agrees to use adequate birth control (hormonal or barrier method of birth control or abstinence) prior to study entry and during the study and agrees not to donate sperm or ova, for the duration of the study and 12 months post implantation of the investigational device.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Evidence of distant metastases, based on review of baseline CT scan.
2. More than one pancreatic tumour lesion.
3. Any prior radiotherapy or chemotherapy for pancreatic cancer.
4. Pregnant or lactating.
5. In the opinion of the investigator, EUS-directed implantation posing undue study subject risk. This includes:

i) where previous EUS-FNA was considered technically too difficult to perform; ii) imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumour within the pancreas; iii) 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 repeated at any time between Screening Visit 1 and the implantation date. If any of the above risk features becomes apparent following subject screening and/or enrolment prior to and including at the time of OncoSil™ treatment, the patient should remain in the study but the implantation should be deferred or cancelled.
6. History of malignancy, treated or untreated, within the past five years whether or not there is evidence of local recurrence or metastases, with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ.
7. Evidence of radiographic invasion into stomach or duodenum (if not certain, confirmation must be obtained prior to enrolment).
8. A known history of hypersensitivity to silicon or phosphorous, or any of the OncoSil™ components.
9. Any other health condition that would preclude participation in the study in the judgment of the investigator.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Epworth Healthcare - Richmond
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Richmond
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Ghent
Country [2] 0 0
Italy
State/province [2] 0 0
Rome
Country [3] 0 0
Italy
State/province [3] 0 0
Verona
Country [4] 0 0
Spain
State/province [4] 0 0
Barcelona
Country [5] 0 0
Spain
State/province [5] 0 0
Madrid
Country [6] 0 0
Spain
State/province [6] 0 0
Pamplona
Country [7] 0 0
Spain
State/province [7] 0 0
Valencia
Country [8] 0 0
United Kingdom
State/province [8] 0 0
London
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Manchester
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Newcastle Upon Tyne
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
OncoSil Medical Limited
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Michele Milella, MD, PhD
Address 0 0
University Hospital of Verona
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Henk Tissing
Address 0 0
Country 0 0
Phone 0 0
+31651384883
Fax 0 0
Email 0 0
henk.tissing@oncosil.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD may be shared on an individual basis to study investigators subject to review and approval from the study publication steering committee

Supporting document/s available: Study protocol, Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
After the release of the primary study publication
Available to whom?
Request should be made to the chair of the publication steering committee with specification of the proposed analysis and the required IPD
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05466799