OncoSil Pancreatic Cancer Post-marketing Clinical Registry - Italy

Locally Advanced Pancreatic Adenocarcinoma Clinical Trial

— OSPRItaly  

Official title:

OncoSil Pancreatic Cancer Post-marketing Clinical Registry Italy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06399172
• Other study ID #: OSPRItaly01
• Status: Not yet recruiting
• Start date: May 30, 2024
• Est. completion date: October 30, 2029

Study information

• Verified date: May 2024
• Source: OncoSil Medical Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 30, 2029
• Est. primary completion date: May 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPRItaly Patient Registry.

Exclusion Criteria:

1. Patients participating in an interventional clinical study (company or investigator-sponsored).

2. Use of an investigational agent at the time of enrolment.

Related Conditions & MeSH terms

• Locally Advanced Pancreatic Adenocarcinoma

Intervention

Device:
• OncoSil
Intra-tumoural implantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
OncoSil Medical Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Followed to death or to 24-months after the date of the last enrolled patient.
Primary	Tumour response	Target (implanted) tumour response (local and distant)	1 year
Primary	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.	1 year
Primary	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.	Followed to death or to 24-months after the date of the last enrolled patient
Primary	Resection Rates	Surgical resection rates and outcome	Followed to death or 24 months after the date of the last enrolled patient