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OncoSil™ implanted with concurrent Standard of care Chemotherapy - either FOLFIRINOX or gemcitabine + Abraxane.

OncoSil™

Paul J Ross, MRCP MBBS

To evaluate the safety of OncoSil™ in a patient population undergoing standard chemotherapy treatment for pancreatic cancer. This study has been designed to satisfy regulatory requirements.

The clinical investigation will be conducted at approximately 15 sites in Australia, the United Kingdom and Europe (Belgium) involving 40 patients.

Detailed description

The purpose of this research study is to investigate the safety of an active implantable (radiological) medical device OncoSil™, when implanted into patients with pancreatic cancer, in conjunction with Standard of Care (SOC) chemotherapy. OncoSil™, is an experimental treatment and carries the active treatment "radioactive Phosphorous (32P)" inside inactive silicon particles. Once implanted, the OncoSil™ Microparticles will stay in the tumour permanently. The purpose of OncoSil™, is to deliver the action of 32P directly into a targeted tumour to destroy cancer cells.

40 Patients will be taking part in a single arm open label research study - which means that everyone in the research study will receive the investigational treatment OncoSil™, plus their prescribed standard chemotherapy regimen which will be either; FOLFIRINOX (FOLFIRINOX is the name of a combination of chemotherapy drugs used to treat advanced cancer of the pancreas) or gemcitabine + nab-paclitaxel (Abraxane).

Endpoints: Primary Endpoint:

• Safety and Tolerability

Secondary Endpoints:

Efficacy

* Local Disease Control Rate at 16 weeks
* Local Progression Free Survival (LPFS), within the pancreas
* Progression Free Survival (PFS), all sites
* Overall Survival (OS)
* Body weight
* Impaired function
* Pain Scores

The screening period will be performed within a 2 week period, followed by a treatment period of investigational visits which will occur weekly from Day 0 (Visit 1) until week 12, then 4 weeks later at week 16, and then at 8-weekly intervals until study participants reach documented progression of disease criteria for both LPFS and PFS which marks the end of study participation i.e. EOS visit.

An 8-weekly review of medical records will be used to monitor possible device or late radiation related adverse events, and oncology treatments/procedures administered for up to 12 months post OncoSil™ implantation.

Overall survival will be conducted via 8-weekly medical record reviews until study participant death, or until 104 weeks post the last study participant enrolled.

Activity (Dose): The intended average absorbed radiation dose per treated tumour is 100 Gy (+20%).

Risks associated with OncoSil™ and/or implantation procedure

The following adverse events, considered to have a causal relationship with OncoSil™ or procedure, were recorded during previous clinical studies:

* Procedure-related pain
* Abdominal pain and discomfort
* Lethargy
* Fever
* Nausea and vomiting
* Abnormal liver function tests

A Pilot Study of OncoSil™ Given to Patients With Pancreatic Cancer Treated With FOLFIRINOX or Gemcitabine+Abraxane

An Open Label, Single Arm Pilot Study of OncoSil™, Administered to Study Participants With Unresectable Locally Advanced Pancreatic Adenocarcinoma, Given in Combination With FOLFIRINOX or Gemcitabine+Nab-paclitaxel Chemotherapies

as demonstrated by target tumour volumetric change (measured by a central reading centre)

as demonstrated by target tumour FDG-PET parameters (measured by a central reading centre)

as determined by the number of treatment emergent adverse events (TEAEs) evaluated

Central reader review of CT changes throughout study enrolment

as measured by changes in the Karnofsky Performance Status from screening

As measured at each study visit using the Numerical Rating scale (NRS)

OncoSil Medical Limited

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Micronutrients

Hematinics

Vitamins

Oxaliplatin

Leucovorin

Fluorouracil

Irinotecan

Levoleucovorin

Folic Acid

Topoisomerase I Inhibitors

Enzyme Inhibitors

Folinic Acid

Folate

Vitamin B9

Subjects in Arm A will receive up to 12 cycles of Standard Of Care 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

Standard Of Care Chemotherapy regimen for treatment of Locally Advanced Pancreatic cancer

FOLFIRINOX chemotherapy

Implantation of OncoSil 32P microparticles into the Pancreatic Tumour under EUS guidance

Henk Tissing

Tom Maher

Nam Nguyen, MD

Daniel Croagh, MD

Els Monsaert, MD

Carlo Garufi, MD

Guido Ventroni, MD

Michele Milella, MD

Giuseppe Malleo, MD

Teresa Macarulla, MD

Andrés Muñoz, MD

Rocio Garcia-Carbonero, MD

Ignacio Juez, MD

Carmen Guillen Ponce, MD

Mariano Ponz Sarvisé, MD

Paul Ross, MD

Harpreet Wasan, MD

Richard Hubner, MD

Joe Geraghty, MD

Sanjay Pandanaboyana, MD

Ben Maher, MD

Michele Milella, MD, PhD

Giuseppe Malleo, MD, PhD

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

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.

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.

IPD may be shared on an individual basis to study investigators subject to review and approval from the study publication steering committee

The primary analysis for safety of OncoSil™ is defined by the Adverse Event profile

The LDCR at Week 16 will be summarised as a count and proportion of subjects with Local Disease Control at 16 Weeks

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.

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.

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

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

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.

Overall survival (OS) is the time from enrolment to the date of death from any cause.

EQ-5D, EORTC QLQ-C30 and PAN26 will be analyses per their validated methodology

weight will be assessed at all applicable study visits

assessment of rate of secondary R0/R1 resection

A central reading centre will analyse all CT scans to measure target tumour volume changes from baseline.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Pilot Study of OncoSil™ Given to Patients With Pancreatic Cancer Treated With FOLFIRINOX or Gemcitabine+Abraxane	NCT03003078	Unresectable Lo...	OncoSil™	18 Years -	OncoSil Medical Limited
FOLFIRINOX Versus OncoSil™ in Addition to FOLFIRINOX in Patients With Locally Advanced Pancreatic Adenocarcinoma	NCT05466799	Locally Advance...	FOLFIRINOX chem... OncoSil™	18 Years -	OncoSil Medical Limited

Spots Global Cancer Trial Database for oncosil™

Every month we try and update this database with for oncosil™ cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for oncosil™

Every month we try and update this database with for oncosil™ cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for oncosil™ cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.