Trial purpose
Cancer treatment
Tumor type
Upper gastrointestinal tract
Age
18+
Clinical summary
Summary
OncoSil™ is a single-use brachytherapy (also known as internal radiation therapy) device used to deliver a pre-determined dose of beta radiation directly into cancerous tissue.
The purpose of this study is to assess the safety and efficacy of OncoSil™ when given in addition to standard FOLFIRINOX chemotherapy regimen for treatment of locally advanced pancreatic cancer that is unable to be removed with surgery (unresectable).
Eligible participants will be randomly allocated to one of two treatment arms.
- The Control Arm will receive up to 12 cycles of standard of care FOLFIRINOX chemotherapy regimen.
- The Experimental Arm will receive the implantation of OncoSil™ in addition to the same FOLFIRINOX chemotherapy regiment.
Participants will be followed for 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
This trial is treating people with locally advanced pancreatic cancer unable to be removed through surgery
Eligibility
Inclusion
- Histologically or cytologically proven adenocarcinoma of the pancreas.
- Unresectable locally advanced pancreatic adenocarcinoma according to NCCN 2021 guidelines.Staging and unresectability must be confirmed by central review of the baseline CT scan.
- Pancreatic target tumour diameter of < 7.0 cm (longest axis), as qualified by the central reading centre.
- Karnofsky Performance Status ≥ 70
- ≥ 18 years of age at screening.
-
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.
- Provide signed Informed Consent.
- Willing and able to complete study procedures within the study timelines.
- Life expectancy of at least 3 months at the time of screening as judged by the investigator.
- 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.
- 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
- Evidence of distant metastases, based on review of baseline CT scan.
- More than one pancreatic tumour lesion.
- Any prior radiotherapy or chemotherapy for pancreatic cancer.
- Pregnant or lactating.
-
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.
- 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.
- Evidence of radiographic invasion into stomach or duodenum (if not certain, confirmation must be obtained prior to enrolment).
- A known history of hypersensitivity to silicon or phosphorous, or any of the OncoSil™ components.
- Any other health condition that would preclude participation in the study in the judgment of the investigator.
Inclusion
- Your cancer has not spread to other parts of the body (localised).
- Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
OncoSil Medical Limited
Scientific 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.
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