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FOLFIRINOX Versus OncoSil™ in Addition to FOLFIRINOX in Patients With Locally Advanced Pancreatic Adenocarcinoma
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-04-26
Primary completion: 2024-06-01
Study completion finish: 2024-09-01
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT05466799
Intervention or treatment
DRUG: FOLFIRINOX chemotherapy
DEVICE: OncoSil™
Conditions
- • Locally Advanced Pancreatic Cancer
Find a site
Closest Location:
Royal Adelaide Hospital
Research sites nearby
Select from list below to view details:
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Epworth Healthcare
Richmond, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
ACTIVE_COMPARATOR: FOLFIRINOX Chemotherapy
| DRUG: FOLFIRINOX chemotherapy
|
EXPERIMENTAL: OncoSil™ in addition to FOLFIRINOX Chemotherapy
| DRUG: FOLFIRINOX chemotherapy
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Safety and Tolerability | The primary analysis for safety of OncoSil™ is defined by the Adverse Event profile | Through study completion, an average of 18 months |
Local Disease Control Rate (LDCR) at 16 Weeks | The LDCR at Week 16 will be summarised as a count and proportion of subjects with Local Disease Control at 16 Weeks | 16 weeks after initiation of FOLFOX chemotherapy |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Local Progression Free Survival (LPFS), within the pancreas | Local Progression Free Survival (LPFS) is defined as the time from enrolment to the date of the radiological scan used to determine local tumour progression or date of death from any cause, whichever comes first. | 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 |
Progression Free Survival | Progression free survival (PFS) is defined as the time from enrolment to the date of tumour progression or of recurrence (in case of complete response (CR) or resection of the primary pancreatic tumour), or death from any cause, whichever comes first. | 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 |
Time to symptomatic progression | Time to symptomatic progression is defined as the time between enrolment and worsening of cancer related symptoms as measured by the symptoms domains of QLQ-C30/PAN26 | 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 |
Clinical Benefit Response | Clinical Benefit Response is a composite endpoint consisting of weight, Performance Status and pain score and will be derived at 4 weekly intervals.The frequency and percentage of subjects with a clinical benefit response will be summarised | 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 |
CA 19-9 response | CA 19-19 response will be defined as ≥ 50% decline from baseline and ≥ 90% decline from baseline and return to normal range respectively. Subgroups will be created for study subjects with CA 19-9 \> ULN at baseline. | 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 |
Overall Survival | Overall survival (OS) is the time from enrolment to the date of death from any cause. | Through study completion, an average of 18 months |
Patient Reported Outcomes | EQ-5D, EORTC QLQ-C30 and PAN26 will be analyses per their validated methodology | Through study completion, an average of 18 months |
Pain Scores | NRS and QLC-PAN26 | 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 |
Weight loss | weight will be assessed at all applicable study visits | 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 |
Tumour response | RECIST 1.1 per central review | 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 |
Surgical resection rate | assessment of rate of secondary R0/R1 resection | Through study completion, an average of 18 months |
Target Tumour Volumetric Change | A central reading centre will analyse all CT scans to measure target tumour volume changes from baseline. | 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 |
Frequently Asked Questions
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