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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03003078
Recruitment Status : Active, not recruiting
First Posted : December 26, 2016
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
OncoSil Medical Limited

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Unresectable Locally Advanced Pancreatic Carcinoma Device: OncoSil™ Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 27, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Gemcitabine

Arm Intervention/treatment
OncoSil™ plus SOC Chemotherapy
OncoSil™ implanted with concurrent Standard of care Chemotherapy - either FOLFIRINOX or gemcitabine + Abraxane.
Device: OncoSil™
The implantation of OncoSil™




Primary Outcome Measures :
  1. Safety / Tolerability of Device according to CTCAE V4.0 [ Time Frame: Collected from the of signed informed consent until patient death or 104 weeks post last patient enrollment date, whichever is sooner ]
    as determined by the number of treatment emergent adverse events (TEAEs) evaluated


Secondary Outcome Measures :
  1. Local Progression free survival within the pancreas [ Time Frame: Assessed from Baseline through to first confirmed CT documentation of local progression within the pancreas, an average of 12 months. ]
    Central reader review of CT changes throughout study enrolment

  2. Progression free survival - entire body [ Time Frame: Assessed from Baseline through to EOS visit - an average of 12 months. ]
    Central reader review of CT changes throughout study enrolment

  3. Overall survival [ Time Frame: 104 weeks post last patient first study visit ]
    Time to participant death from enrolment

  4. Body weight [ Time Frame: Assessed from Baseline through to EOS visit, an average of 12 months. ]
    Recorded body weight at each study visit

  5. Impaired function [ Time Frame: Frame: Measured at each study visit for the duration of the study, an average of 12 months ]
    as measured by changes in the Karnofsky Performance Status from screening

  6. Pain Scores [ Time Frame: Measured at each study visit for the duration of the study, an average of 12 months ]
    As measured at each study visit using the Numerical Rating scale (NRS)


Other Outcome Measures:
  1. tumour response [ Time Frame: Baseline measure from screening period, compared to Week 8 CT result, and then to 8 weekly CT results until local progression is determined, an average of 12 months. ]
    as demonstrated by target tumour volumetric change (measured by a central reading centre)

  2. tumour response [ Time Frame: As assessed at Week 12 study visit compared to Baseline assessment completed during screening period ]
    as demonstrated by target tumour FDG-PET parameters (measured by a central reading centre)



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 carcinoma. Patients with technically resectable tumours (T1-T3) will also be eligible, if they are deemed unresectable due to medical comorbidities or refusal of surgery.
  3. Pancreatic target tumour diameter of ≥ 2.0 cm (shortest axis) to ≤ 6.0 cm (longest axis), as qualified by the central reading centre.
  4. An ECOG Performance Status of 0 to 1 and Karnofsky Performance Status of 80 - 100.
  5. Study participants ≥ 18 years of age at screening.
  6. To commence first-line standard FOLFIRINOX or gemcitabine+nab-paclitaxel chemotherapy (per standard of care according to the approved prescribing schedule), within 14 days post enrolment, with OncoSil™ implantation to occur during the fourth (4th) week of the first chemotherapy cycle.
  7. Provide signed Informed Consent.
  8. Willing and able to complete study procedures within the study timelines.
  9. Adequate renal function: serum creatinine less than 1.5 x upper limit of normal (ULN).
  10. Adequate liver function: serum liver transaminases ≤ 3 × ULN and serum bilirubin

    ≤ 1.5 × 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 × ULN.

  11. 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.
  12. Life expectancy of at least 3 months at the time of screening as judged by the investigator.
  13. 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.
  14. 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, as determined by the central reading centre.
  2. More than one primary lesion.
  3. Any prior radiotherapy or chemotherapy for pancreatic cancer.
  4. Use of other investigational agent at the time of screening, or within 30 days or five half-lives of Screening Visit 1, whichever is longer.
  5. Pregnant or lactating.
  6. In the opinion of the investigator, EUS directed implantation posing undue study participant risk. This includes:

    • where previous EUS-FNA was considered technically too difficult to perform;
    • imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumour within the pancreas;
    • 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 conducted at any time between Screening Visit 1 and the implantation date. A study participant should be considered for withdrawal prior to and including at the time of OncoSil™ treatment, if any of the above risk features become apparent following subject screening and/or enrolment.
  7. 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.
  8. Evidence of radiographic invasion into stomach, duodenum or peritoneum (if not certain confirmation must be obtained prior to enrolment).
  9. A known allergy or history of hypersensitivity to silicon, phosphorous or any of the OncoSil™ components.
  10. Any other health condition that would preclude participation in the study in the judgment of the investigator.

Note: T1-T3 is determined as per The American Joint Committee on Cancer (AJCC) tumor/node/metastasis (TNM) classification and staging system for pancreatic cancer


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): NCT03003078


Locations
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Australia, New South Wales
Corrimal Cancer Care Clinic, 20-22 Underwood St
Corrimal, New South Wales, Australia, 2518
Department of Medical Oncology, Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
The Kinghorn Cancer Centre, St Vincent's Hospital
Sydney, New South Wales, Australia, 2010
The Crown Princess Mary Cancer Centre, Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, South Australia
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Institute for Breathing and Sleep -Bowen CentreAustin Health
Heidelberg, Victoria, Australia, 3084
Monash Cancer Centre
Melbourne, Victoria, Australia, 3165
Belgium
Institut Jules Bordet
Bruxelles, Belgium
United Kingdom
Cambridge Cancer Trials Centre, Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Leicester Royal Infirmary
Leicester, East Midlands, United Kingdom, LEI 5WW
Guy's and St Thomas' NHS Foundation Trust,
London, Greater London, United Kingdom, SE19RT
Hammersmith Hospital
London, United Kingdom, W12 0HS
Sponsors and Collaborators
OncoSil Medical Limited
Investigators
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Principal Investigator: Paul J Ross, MRCP MBBS Guy's and St Thomas' NHS Foundation Trust
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Responsible Party: OncoSil Medical Limited
ClinicalTrials.gov Identifier: NCT03003078    
Other Study ID Numbers: ONC01P03
First Posted: December 26, 2016    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by OncoSil Medical Limited:
Pancreatic cancer
Pancreas
metastases
pancreatic tumour
unresectable
locally advanced
implantable
radiographic
device
Phosphorous-32
OncoSil™
brachytherapy
FOLFIRINOX
gemcitabine
nab-paclitaxel
Abraxane
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases