None listed
Conditions
Brief summary
Brief description of the study purpose This study is being conducted to determine whether adding a targeted internal radiation treatment called OncoSil™ (Phosphorus-32 microparticles) to standard chemotherapy improves outcomes for patients with locally advanced pancreatic cancer. Who is it for? You may be eligible for this study if you are male or female aged 18 or older, with unresectable locally advanced pancreatic adenocarcinoma as per National Comprehensive Cancer Network (NCCN) guidelines, fit to commence first-line standard FOLFIRINOX therapy and have a life expectancy greater than 3 months. Study details Those who are eligible will be randomly allocated to either receive standard FOLFIRINOX chemotherapy alone or chemotherapy plus a single endoscopic ultrasound-guided OncoSil™ implantation into the tumour. Participants will be followed over time with regular scans, blood tests, and health assessments to monitor tumour response, side effects, and quality of life. It is hoped that the results from this study will help determine whether this combined treatment approach is more effective and safe than chemotherapy alone.
Interventions
The substance being investigated for the project is an active implantable (radiological) medical device called OncoSil, which contains the active treatment “radioactive Phosphorus (32-P)” inside inactive silicon particles. These particles are tiny, and range in size from 28 to 32 micrometres, which is smaller than the width of a human hair (which typically ranges in width from 40 to 120 micrometres). The study involves exposure to an amount of ionising radiation in the form of a 32-P implant whi
The substance being investigated for the project is an active implantable (radiological) medical device called OncoSil, which contains the active treatment “radioactive Phosphorus (32-P)” inside inactive silicon particles. These particles are tiny, and range in size from 28 to 32 micrometres, which is smaller than the width of a human hair (which typically ranges in width from 40 to 120 micrometres). The study involves exposure to an amount of ionising radiation in the form of a 32-P implant which is intended to deliver an average absorbed radiation dose per treated tumour of 100 Gy (± 20%). The number of particles inserted into the tumour will range from 120 thousand to 2 million, depending on the dose required per patient. An endoscopic ultrasound (EUS) will be used to implant the particles, allowing the endoscopist to view the pancreas and insert the particles via a fine needle. An endoscope will be guided down the oesophagus, through the stomach and into the first part of the small intestine. The ultrasound is used to image the tumour in the pancreas. A fine needle is extended from the end of the endoscope into the pancreas and into the middle of the tumour. Once this needle is in an appropriate position within the tumour, a doctor will attach a syringe filled with OncoSil to the other end of the needle. The doctor will slowly depress the plunger of the syringe so that the contents of the syringe are implanted into the tumour, the OncoSil syringe is removed. Another syringe contain a small amount of saline is attached to the needle. This will flush any remaining OncoSil from the needle into the tumour. The saline syringe is removed. The endoscope is removed by carefully pulling it back up the oesophagus and out the participants mouth. The implantation procedure will only occur once, as soon as clinically possible in the 2nd week of the 2nd cycle of FOLFIRINOX chemotherapy. Implantation will occur between the 2nd and 3rd cycle, ensuring there is no delay or change to a participants chemotherapy schedule. The implantation procedure via EUS procedure will go for approx. 20-40 minutes. The dose of OncoSil will be calculated prior to the procedure to achieve an Implanted Volume/Tumour Volume of 8% to deliver a dose of 100Gy to the tumour mass. Standard of care diagnostic imaging pre-chemotherapy will be accessed to assist with dose calculations, and on the day of the procedure the dose can be adjusted if the endoscopist determines if the tumour volume has increased/decreased since prior tumour volume assessment. Intervention fidelity will be assessed through review of medical records, procedural reports, and treatment records. OncoSil implantation details will be documented by the treating endoscopist/investigator. Post-implantation Bremsstrahlung SPECT/CT imaging will be performed same day to confirm localisation of implanted OncoSil. The participants adherence to chemotherapy schedules will be assessed through review of chemotherapy administration records.
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Histologically or cytologically proven adenocarcinoma of the pancreas - Unresectable locally advanced pancreatic adenocarcinoma as per National Comprehensive Cancer Network (NCCN) guidelines (MDT review of imaging) - Considered fit to commence first-line standard FOLFIRINOX therapy - Able to provide informed consent - Life expectancy at least 3 months (as assessed by investigator) - An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 - Willing and able to complete study procedures within the study timelines. - Provide signed Informed Consent. - Technically feasible – tumour must be within reach of the EUS probe for fine needle injection. - Standard first line chemotherapy with FOLFIRINOX will be commenced within 14 days post enrolment, with OncoSilTM implantation to occur during the 4th week from commencement of chemotherapy. - Provide signed informed consent
Exclusion criteria
- Evidence of metastatic disease - More than one pancreatic tumour lesion - Any prior radiotherapy or chemotherapy for pancreatic cancer - Use of other investigational agent at the time of screening, or within 30 days or five half-lives of Screening Visit, whichever is longer - Pregnant or lactating - Known history of hypersensitivity to silicon or phosphorus - In the opinion of the investigator, EUS directed implantation posing undue study participant risk. This includes: a) Where previous EUS-FNA was considered technically too difficult to perform due to anatomy/vessels/varices b) Imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumour within the pancreas c) 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 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 participant screening) - Patients who do not consent to chemotherapy
Outcome results
None listed