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.
Detailed description The purpose of this research study is to investigate the safety of an active implantable (radiological) medical device OncoSil™, when implanted into patients with pancreatic cancer, in conjunction with Standard of Care (SOC) chemotherapy. OncoSil™, is an experimental treatment and carries the active treatment "radioactive Phosphorous (32P)" inside inactive silicon particles. Once implanted, the OncoSil™ Microparticles will stay in the tumour permanently. The purpose of OncoSil™, is to deliver the action of 32P directly into a targeted tumour to destroy cancer cells. 40 Patients will be taking part in a single arm open label research study - which means that everyone in the research study will receive the investigational treatment OncoSil™, plus their prescribed standard chemotherapy regimen which will be either; FOLFIRINOX (FOLFIRINOX is the name of a combination of chemotherapy drugs used to treat advanced cancer of the pancreas) or gemcitabine + nab-paclitaxel (Abraxane). Endpoints: Primary Endpoint: • Safety and Tolerability Secondary Endpoints: Efficacy * Local Disease Control Rate at 16 weeks * Local Progression Free Survival (LPFS), within the pancreas * Progression Free Survival (PFS), all sites * Overall Survival (OS) * Body weight * Impaired function * Pain Scores The screening period will be performed within a 2 week period, followed by a treatment period of investigational visits which will occur weekly from Day 0 (Visit 1) until week 12, then 4 weeks later at week 16, and then at 8-weekly intervals until study participants reach documented progression of disease criteria for both LPFS and PFS which marks the end of study participation i.e. EOS visit. An 8-weekly review of medical records will be used to monitor possible device or late radiation related adverse events, and oncology treatments/procedures administered for up to 12 months post OncoSil™ implantation. Overall survival will be conducted via 8-weekly medical record reviews until study participant death, or until 104 weeks post the last study participant enrolled. Activity (Dose): The intended average absorbed radiation dose per treated tumour is 100 Gy (+20%). Risks associated with OncoSil™ and/or implantation procedure The following adverse events, considered to have a causal relationship with OncoSil™ or procedure, were recorded during previous clinical studies: * Procedure-related pain * Abdominal pain and discomfort * Lethargy * Fever * Nausea and vomiting * Abnormal liver function tests
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The implantation of OncoSil™
Corrimal Cancer Care Clinic, 20-22 Underwood St
Corrimal, New South Wales, Australia
Department of Medical Oncology, Royal North Shore Hospital
St Leonards, New South Wales, Australia
The Kinghorn Cancer Centre, St Vincent's Hospital
Safety / Tolerability of Device according to CTCAE V4.0
as determined by the number of treatment emergent adverse events (TEAEs) evaluated
Time frame: Collected from the of signed informed consent until patient death or 104 weeks post last patient enrollment date, whichever is sooner
Local Progression free survival within the pancreas
Central reader review of CT changes throughout study enrolment
Time frame: Assessed from Baseline through to first confirmed CT documentation of local progression within the pancreas, an average of 12 months.
Progression free survival - entire body
Central reader review of CT changes throughout study enrolment
Time frame: Assessed from Baseline through to EOS visit - an average of 12 months.
Overall survival
Time to participant death from enrolment
Time frame: 104 weeks post last patient first study visit
Body weight
Recorded body weight at each study visit
Time frame: Assessed from Baseline through to EOS visit, an average of 12 months.
Impaired function
as measured by changes in the Karnofsky Performance Status from screening
Time frame: Frame: Measured at each study visit for the duration of the study, an average of 12 months
Pain Scores
As measured at each study visit using the Numerical Rating scale (NRS)
Time frame: Measured at each study visit for the duration of the study, an average of 12 months
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Sydney, New South Wales, Australia
The Crown Princess Mary Cancer Centre, Westmead Hospital
Westmead, New South Wales, Australia
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital
Adelaide, South Australia, Australia
Institute for Breathing and Sleep -Bowen CentreAustin Health
Heidelberg, Victoria, Australia
Monash Cancer Centre
Melbourne, Victoria, Australia
Institut Jules Bordet
Brussels, Belgium
Cambridge Cancer Trials Centre, Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
Leicester Royal Infirmary
Leicester, East Midlands, United Kingdom
...and 2 more locations