To evaluate the safety of OncoSil™ in a patient population undergoing standard chemotherapy treatment for pancreatic cancer. This study has been designed to satisfy FDA regulatory requirements. The clinical investigation will be conducted at approximately 5 sites in the United States involving 20 patients.
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 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. 20 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 Gemcitabine or Gemcitabine + nab-paclitaxel (Abraxane). Endpoints: Primary Endpoint: • Safety and Tolerability Secondary Endpoints: Efficacy * 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. 8 weekly telephone contact will be used to monitor 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 and or telephone contact until subject death, or until 104 weeks post the last subject enrolled. 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
9
The implantation of OncoSil™ under EUS
Cedars Sinai Department of Radiation Oncology
Los Angeles, California, United States
Moffitt Cancer Centre
Tampa, Florida, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
MD Anderson Cancer Center
Houston, Texas, United States
Safety / Tolerability of Device as determined by the number of treatment emergent adverse events (TEAEs) evaluated according to CTCAE V4.0
as determined by the number of treatment emergent adverse events (TEAEs) evaluated 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]
Local Progression free survival within the pancreas
As assessed by the central reader review of successive CT scans throughout the study
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
As assessed by the central reader review of successive CT scans throughout the study
Time frame: Assessed from Baseline through to EOS visit - an average of 12 months
Overall survival
As assessed by the time from participant consent to participant death or their survival to 104 weeks past the first study visit on the last subject enrolled in the study.
Time frame: Assessed from Baseline to 104 weeks post last patient first study visit]
Body weight
Measurement of subject 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: Measured at each study visit for the duration of the study, an average of 12 months
Pain Scores
Pain as measured by the numerical rating scale (NRS) at each study visit
Time frame: Measured at each study visit for the duration of the study, an average of 12 months
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