Unresectable Locally Advanced Pancreatic Carcinoma Clinical Trial
An Open Label, Single Arm Pilot Study of OncoSil™, Administered to Study Participants With Unresectable Locally Advanced Pancreatic Adenocarcinoma, Given in Combination With FOLFIRINOX or Gemcitabine+Nab-paclitaxel Chemotherapies
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 ;
|Source||OncoSil Medical Limited|
|Start date||March 27, 2017|
|Completion date||July 31, 2020|