OncoSil Pancreatic Cancer Post-marketing Clinical Registry - Italy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOncoSil Medical Limited
About this trial
The OSPRItaly Patient Registry has been developed to assess the performance and safety of the OncoSil™ device when used within the approved indication of unresectable, locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy, within a real-world observational registry.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who are eligible for and undergo OncoSil™ implantation at an eligible treatment facility according to the approved OncoSil™ System Instructions for Use (IFU), as part of their clinical care.
Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPRItaly Patient Registry.
Disqualifiers
Patients participating in an interventional clinical study (company or investigator-sponsored).
Use of an investigational agent at the time of enrolment.
Trial population
In the participating institutions every patient who is intended to undergo implantation of the OncoSil™ device when used within the approved indication of unresectable, locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy, in the commercial (sales) setting will be approached by the Principal Investigator (or delegate) to consent to participate in the OSPRItaly Patient Registry.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
OncoSil
DeviceIntra-tumoural implantation
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Safety and tolerability
The analysis for safety within the real-world setting will be performed. The safety of OncoSil™ is defined by the Adverse Event profile. All safety summaries will be produced for the Intention-To-Treat (ITT) population. Adverse Device Effects will be coded using Medical Dictionary for Regulatory Activities (MedDRA). All Adverse Device Effects recorded during the Registry will be listed. Summary tables will be produced for Treatment Emergent Adverse Device Effects (TEADEs). The number and percentage of patients with device-related Adverse Events by system organ class (SOC) and preferred term will be tabulated. Similar summaries will be produced by severity of event (both mild, moderate or severe, CTCAE grade 1-4) and device relationship. In addition, summary tables will be produced for serious TEADEs and TEADEs associated with special interest acute/late radiation effects and or withdrawal.
Time frame
Followed to death or to 24-months after the date of the last enrolled patient.2
Tumour response
Target (implanted) tumour response (local and distant)
Time frame
1 year3
Device implantation Performance
Safety of the implantation of OncoSil™ within the target tumour will be measured by means of procedure-related Adverse Events. Ease of administration and implantation related data from user questionnaires will be assessed.
Time frame
1 year4
Overall Survival
Overall survival (OS) is defined as the time from enrolment to the date of death from any cause. Patients who are alive or permanently lost to follow-up at the cut-off date for the analysis will be censored at the last date the patient was known to be alive.
Time frame
Followed to death or to 24-months after the date of the last enrolled patientLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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