FOLFIRINOX Versus OncoSil™ in Addition to FOLFIRINOX in Patients With Locally Advanced Pancreatic Adenocarcinoma

NCT ID: NCT05466799

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-26
• Study Completion Date: 2025-09-30

Brief 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

Locally Advanced Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FOLFIRINOX Chemotherapy

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

Group Type: ACTIVE_COMPARATOR

FOLFIRINOX chemotherapy

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

FOLFIRINOX chemotherapy

Intervention Type: DRUG

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

OncoSil™

Intervention Type: DEVICE

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

Interventions

FOLFIRINOX chemotherapy

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

Intervention Type: DRUG

OncoSil™

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

Intervention Type: DEVICE

Other Intervention Names

Folinic Acid, 5-FU, Oxaliplatin, Irinotecan; Phosphorous-32 microparticles

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OncoSil Medical Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michele Milella, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Verona

Giuseppe Malleo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Verona

Locations

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status: RECRUITING

Epworth Healthcare

Richmond, Victoria, Australia

Site Status: NOT_YET_RECRUITING

AZ Maria Middelares

Ghent, , Belgium

Site Status: RECRUITING

San Camillo Forlanini

Rome, , Italy

Site Status: RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona

Verona, , Italy

Site Status: RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status: RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Site Status: RECRUITING

Hospital Universitario 12 de Octobre

Madrid, , Spain

Site Status: RECRUITING

Hospital Universitario de Fuenlabrada

Madrid, , Spain

Site Status: RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status: RECRUITING

Clínica Universidad de Navarra

Pamplona, , Spain

Site Status: RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, , Spain

Site Status: NOT_YET_RECRUITING

Guy's Hospital

London, , United Kingdom

Site Status: NOT_YET_RECRUITING

Imperial College

London, , United Kingdom

Site Status: RECRUITING

The Christie Hospital/Manchester Royal Infirmary

Manchester, , United Kingdom

Site Status: RECRUITING

Freeman Hospital

Newcastle upon Tyne, , United Kingdom

Site Status: RECRUITING

University Hospital Southampton

Southampton, , United Kingdom

Site Status: RECRUITING

Countries

Australia; Belgium; Italy; Spain; United Kingdom

Central Contacts

Henk Tissing

Role: CONTACT

henk.tissing@oncosil.com

+31651384883

Tom Maher

Role: CONTACT

tom.maher@oncosil.com

Facility Contacts

Nam Nguyen, MD

Role: primary

Daniel Croagh, MD

Role: primary

Els Monsaert, MD

Role: primary

Carlo Garufi, MD

Role: primary

Guido Ventroni, MD

Role: backup

Michele Milella, MD

Role: primary

Giuseppe Malleo, MD

Role: backup

Teresa Macarulla, MD

Role: primary

Andrés Muñoz, MD

Role: primary

Rocio Garcia-Carbonero, MD

Role: primary

Ignacio Juez, MD

Role: primary

Carmen Guillen Ponce, MD

Role: primary

Mariano Ponz Sarvisé, MD

Role: primary

Alejandra Gimenez, MD

Role: primary

Paul Ross, MD

Role: primary

Harpreet Wasan, MD

Role: primary

Richard Hubner, MD

Role: primary

Joe Geraghty, MD

Role: backup

Sanjay Pandanaboyana, MD

Role: primary

Ben Maher, MD

Role: primary

Other Identifiers

ONCO01P04

Identifier Type: -

Identifier Source: org_study_id