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FOLFIRINOX Versus OncoSil™ in Addition to FOLFIRINOX in Patients With Locally Advanced Pancreatic Adenocarcinoma (TRIPP-FFX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05466799
Recruitment Status : Not yet recruiting
First Posted : July 20, 2022
Last Update Posted : November 9, 2022
Sponsor:
Information provided by (Responsible Party):
OncoSil Medical Limited

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

Condition or disease Intervention/treatment Phase
Locally Advanced Pancreatic Cancer Drug: FOLFIRINOX chemotherapy Device: OncoSil™ Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Estimated Study Start Date : January 2023
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: FOLFIRINOX Chemotherapy
Subjects in Arm A will receive up to 12 cycles of Standard Of Care FOLFIRINOX chemotherapy
Drug: FOLFIRINOX chemotherapy
Standard Of Care Chemotherapy regimen for treatment of Locally Advanced Pancreatic cancer
Other Name: Folinic Acid, 5-FU, Oxaliplatin, Irinotecan

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
Drug: FOLFIRINOX chemotherapy
Standard Of Care Chemotherapy regimen for treatment of Locally Advanced Pancreatic cancer
Other Name: Folinic Acid, 5-FU, Oxaliplatin, Irinotecan

Device: OncoSil™
Implantation of OncoSil 32P microparticles into the Pancreatic Tumour under EUS guidance
Other Name: Phosphorous-32 microparticles




Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: Through study completion, an average of 18 months ]
    The primary analysis for safety of OncoSil™ is defined by the Adverse Event profile

  2. Local Disease Control Rate (LDCR) at 16 Weeks [ Time Frame: 16 weeks after initiation of FOLFOX chemotherapy ]
    The LDCR at Week 16 will be summarised as a count and proportion of subjects with Local Disease Control at 16 Weeks


Secondary Outcome Measures :
  1. Local Progression Free Survival (LPFS), within the pancreas [ Time Frame: 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 ]
    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.

  2. Progression Free Survival [ Time Frame: 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 ]
    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.

  3. Time to symptomatic progression [ Time Frame: 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 ]
    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

  4. Clinical Benefit Response [ Time Frame: 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 ]
    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

  5. CA 19-9 response [ Time Frame: 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 19-19 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.

  6. Overall Survival [ Time Frame: Through study completion, an average of 18 months ]
    Overall survival (OS) is the time from enrolment to the date of death from any cause.

  7. Patient Reported Outcomes [ Time Frame: Through study completion, an average of 18 months ]
    EQ-5D, EORTC QLQ-C30 and PAN26 will be analyses per their validated methodology

  8. Pain Scores [ Time Frame: 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 ]
    NRS and QLC-PAN26

  9. Weight loss [ Time Frame: 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 will be assessed at all applicable study visits

  10. Tumour response [ Time Frame: 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 ]
    RECIST 1.1 per central review

  11. Surgical resection rate [ Time Frame: Through study completion, an average of 18 months ]
    assessment of rate of secondary R0/R1 resection

  12. Target Tumour Volumetric Change [ Time Frame: 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 ]
    A central reading centre will analyse all CT scans to measure target tumour volume changes from baseline.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05466799


Contacts
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Contact: Henk Tissing +31651384883 henk.tissing@oncosil.com
Contact: Tom Maher tom.maher@oncosil.com

Sponsors and Collaborators
OncoSil Medical Limited
Investigators
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Principal Investigator: Michele Milella, MD, PhD University Hospital of Verona
Principal Investigator: Giuseppe Malleo, MD, PhD University Hospital of Verona
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Responsible Party: OncoSil Medical Limited
ClinicalTrials.gov Identifier: NCT05466799    
Other Study ID Numbers: ONCO01P04
First Posted: July 20, 2022    Key Record Dates
Last Update Posted: November 9, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD may be shared on an individual basis to study investigators subject to review and approval from the study publication steering committee
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Analytic Code
Time Frame: After the release of the primary study publication
Access Criteria: Request should be made to the chair of the publication steering committee with specification of the proposed analysis and the required IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Oxaliplatin
Irinotecan
Folfirinox
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action