None listed
Conditions
Brief summary
Who is it for? You may be eligible for this study if you are 18 years or older, and have been diagnosed with locally advanced pancreatic cancer (LAPC), Purpose of the study To investigate the safety of an active implantable (radiological) medical device called OncoSil, when implanted into patients with pancreatic cancer who are receiving standard chemotherapy, and to evaluate the response on the tumour after implantation. This will be compared to those who receive standard chemotherapy alone. Allocation to receive OncoSil treatment will be at the discretion of the investigator of the study, and your treating physician and oncologist. Study Details Participants that will receive the OncoSil treatment will undergo an Endoscopic Ultrasound, to accurately visualise the pancreas and assess tumour size. This will be performed under sedation and you are not likely to feel any pain during the process. The doctor guides the endoscope 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 containing a small amount of saline (salt water solution) 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 of your mouth. Following implantation, you will be observed for a minimum of four hours and, if stable and pain-free, you may be discharged the same day. You will be required to attend two follow up visits with you study doctor, which will occur 4 weeks and 12 weeks after the OncoSil procedure. We hope this research will help provide further information on the safety and usefulness of this form of treatment for LAPC, and the results support further evaluation with larger trials.
Interventions
Treatment: Devices - OncoSil™
OncoSil™ is a brachytherapy medical device comprised of OncoSil™ Phosphorus-32 Microparticles and OncoSil™ Diluent. OncoSil is an active implantable (radiological) medical device intended for use in brachytherapy, where cancer is treated by the insertion of radioactive implants directly into the cancerous tissue. OncoSil™ has been designed to be injected directly into, and to deliver an average absorbed dose of 100 Gy to the target treatment tumour. In therapeutic u
Treatment: Devices - OncoSil™ OncoSil™ is a brachytherapy medical device comprised of OncoSil™ Phosphorus-32 Microparticles and OncoSil™ Diluent. OncoSil is an active implantable (radiological) medical device intended for use in brachytherapy, where cancer is treated by the insertion of radioactive implants directly into the cancerous tissue. OncoSil™ has been designed to be injected directly into, and to deliver an average absorbed dose of 100 Gy to the target treatment tumour. In therapeutic use 98% of the radiation is delivered within 81 days. OncoSil is supplied sterile and is intended for single patient single-use. When the baseline tumour volume is available to the Investigator and the study participant is deemed eligible, the investigator will prescribe the radioactivity dose to be implanted (mL). The purpose of OncoSil is to deliver radiation from Phosphorous-32 (32P) directly into the tumour to destroy cancer cells. The radiation particles will only travel a short distance (i.e. approximately 2.76 mm) inside the tumour and therefore very little radiation will leave the body. Once consented participants are to receive either: (i) OncoSil plus concurrent Standard of Care (SOC) Chemotherapy - either FOLFIRINOX or gemcitabine + Abraxane; or (ii) SOC Chemotherapy alone – either FOLFIRINOX or gemcitabine + Abraxane. Participants will be allocated to treatment arm that are correctly considered most appropriate given their individual circumstances. This will be at the discretion of their treating physician, oncologist, and investigator. Implantation of OncoSil is performed using a disposable Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA) needle, loaded through the biopsy channel of the echoendoscope and slowly advanced through the gastric wall or duodenal wall into the target pancreatic tumour (avoiding vessels and avoiding damage to surrounding organs) using endoscopic ultrasound guidance. The position of the needle tip within a tumour will be identified by endoscopic ultrasound localisation prior to injection. The Endoscopist, who will perform the procedure, will determine the needle placement intratumourally. The required amount of OncoSil is then implanted within the tumour by an Authorised User. The anticipated duration of the procedure is 30-60 minutes. Participants in the OncoSil allocation group will only receive the procedure once as the product is single-use. The procedure visit is expected to occur approximately 4 weeks after commencement of chemotherapy. Following implantation, participants will be observed for a minimum of four hours and, if stable and pain-free, will be discharged the same day. An overnight stay is optional and is at the discretion of the study doctor. Once discharged from the endoscopy suite, the study doctor or a member of the research staff will direct participants to the Nuclear Medicine department to have a Bremsstrahlung Scan. This scan is performed to confirm radioactivity and positioning of the implant. The scan is expected to go for 40 minutes, and when this is complete the participant is free to leave the hospital.
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Study participants are greater than/equal to 18 years of age at screening. 2. Histologically or cytologically proven adenocarcinoma of the pancreas. 3. 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. 4. Pancreatic target tumour diameter of less than/equal to 6.0 cm (longest axis) 5. An ECOG Performance Status of 0 to 1 and Karnofsky Performance Status of 80 – 100. 6. Standard first line chemotherapy with FOLFIRINOX will be commenced within 14 days post enrolment, with OncoSil implantation to occur during the 4th week from commencement of chemotherapy. 7. Willing and able to complete study procedures within the study timelines. 8. Adequate renal function: serum creatinine less than 1.5 x upper limit of normal (ULN). 9. Adequate liver function: Serum SGOT/AST and serum SGPT/SLT less than 3 times ULN and serum bilirubin less than 1.5 times the ULN unless the patient is known to have prior Gilbert’s Syndrome. 10. Adequate bone marrow function: white blood cells (WBCs) greater than/equal to 3,000/mm3, absolute neutrophil count (ANC) greater than/equal to 1,500/mm3, haemoglobin greater than/equal to 9 g/dL, and platelets greater than/equal to 100,000/mm3. 11. Life expectancy of at least 3 months at the time of screening as judged by the investigator. 12. 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. 13. Provide signed Informed Consent. 14. Technically feasible – tumour must be within reach of the EUS probe for fine needle injection
Exclusion criteria
1. Evidence of distant metastases 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. 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 tumour invasion into stomach, duodenum or peritoneum 8. 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; (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. 9. A known allergy or history of hypersensitivity to silicon, Phosphorus or any of the OncoSil™ components. 10. Patients who do not consent to chemotherapy 11. Actively on medication that increase bleeding risk (i.e. aspirin, clopidogrel, warfarin, NOAC) 12. Any other health condition that would preclude participation in the study in the judgment of the investigator.
Outcome results
None listed