Clinical Trials in Spain / NCT04493632
Recruiting
Observational
OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.
NCT04493632 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Pancreatic NeoplasmDigestive System NeoplasmNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmDigestive System DiseasePancreatic DiseasesEndocrine System Diseases
Study summary
The OSPREY Patient Registry has been developed to collect and 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.
The Registry data will provide both complementary and contemporary information to the existing clinical data across various countries and will form part of the post-market clinical follow-up activities for OncoSil™. Therefore, the Registry will be implemented only in countries with regulatory (commercial) approval for the OncoSil™ device.
Eligibility
Inclusion Criteria:
1. Patients with confirmed unresectable locally advanced pancreatic cancer (LAPC).
2. Patients who undergo OncoSil™ implantation at an eligible treatment facility.
3. Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPREY Patient Registry.
4. Pancreatic target tumour recommended size of \<7 cm (longest diameter) and \<110 cc volume.
5. A clinically acceptable ECOG performance status.
6. Patients ≥ 18 years of age at screening.
7. To commence gemcitabine-based chemotherapy, (per Standard-of-Care are according to the approved prescribing schedule) post Registry enrolment.
8. Adequate biochemical tests, coagulation profile, haematological, renal, and hepatic function as determined by the Treating Physician.
Exclusion Criteria:
1. Patient Informed Consent Form (PICF) has not been completed and signed for the OSPREY Patient Registry.
2. Patients treated with OncoSil™ within an approved interventional clinical study (company or investigator-sponsored).
3. Evidence of distant metastases based on review of baseline CT scan.
4. More than one primary lesion.
5. In the opinion of the Treating Physician, EUS-directed implantation posing undue patient risk. This includes:
* where previous EUS-FNA was considered technically too difficult to perform;
* imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumour within the pancreas;
* presence (or significant risk) of varices near to the target tumour.
6. Evidence of radiographic invasion into stomach or duodenum (if not certain, confirmation must be obtained prior to enrolment).
7. In the setting of recent, clinically significant pancreatitis, implantation is not recommended.
8. Pregnant or intending to commence a pregnancy within 12-months of the intended date of implantation or breastfeeding.
9. Patients who have a known history of hypersensitivity to silicon or phosphorous, or any of the OncoSil™ components
Primary outcome measure(s)
- Safety and tolerability of Device — Followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™
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 events will be coded using Medical Dictionary for Regulatory Activities (MedDRA). All Adverse Events recorded during the Registry will be listed. Summary tables will be produced for Treatment Emergent Adverse Events (TEAEs). 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 drug and/or device relationship. In addition, summary tables will be produced for serious TEAEs and TEAEs associated with special interest acute/late radiation effects and or withdrawal. - Device Implantation Performance — 7 years
Safety of the implantation of OncoSil™ within the target tumour will be measured by means of procedure-related Adverse Events. An assessment of the utility of OncoSil™ Implantation will be made and listed appropriately. - Overall Survival — Followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™
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. Overall Survival (OS) will be analysed at the interim analysis and once all 500 OncoSil™ implanted patients have been followed to death or to 24-months post the date of the last enrolled/treated patient. - tumour response as demonstrated by target tumour response demonstrated by RECIST 1.1 — 7 years
Target (implanted) tumor response (local and distant) - Resection Rates — 7 years
Surgical resection rates and outcome
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Complejo Hospitalario Universitario Insular Materno-Infantil | Las Palmas de Gran Canaria | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal | Madrid | Spain | Recruiting |
| Hospital Universitario de Fuenlabrada | Madrid | Spain | Recruiting |
| Hospital Universitario Doce De Octobre | Madrid | Spain | Not Yet Recruiting |
| Hospital Universitario La Paz | Madrid | Spain | Not Yet Recruiting |
| Clinica Universidad De Navarra | Pamplona | Spain | Recruiting |
| Hospital Clinico Universitario De Valladolid | Valladolid | Spain | Recruiting |
| Hammersmith Hospital | London | United Kingdom | Not Yet Recruiting |
| The London Clinic | London | United Kingdom | Not Yet Recruiting |
More OncoSil Medical Limited trials in Spain
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04493632 on ClinicalTrials.gov ↗ ← All trials in Spain