Clinical trial NCT04493632: OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.
Official title: OncoSil Pancreatic Cancer Post-marketing Clinical REgistrY (OSPREY)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Neoplasm
Digestive System Neoplasm
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasm
Digestive System Disease
Pancreatic Diseases
Endocrine System Diseases
Keywords: Pancreatic Cancer
Pancreas
Metastases
Pancreatic tumor
Unresectable
Locally advanced
Implantable
Radiographic
Device
Phosphorous-32
OncoSil™
Brachytherapy
Gemcitabine
Nab-paclitaxel
Abraxane
Lead sponsor: OncoSil Medical Limited
Sponsor class: INDUSTRY
First posted: 2020-07-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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 Treating Physician to consent to participate in the OSPREY Patient Registry.

Patients who choose not to consent to participate in the OSPREY Patient Registry will not be excluded from being treated with the OncoSil™ device.

.

Brief 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.

Detailed description: OSPREY is a post-market, global, multicentre, observational, prospective registry in which data is recorded from patients who undergo OncoSil™ device implantation.

Countries intended for initial commercial distribution include Australia, Belgium, France, Germany, Italy, Singapore, Spain, \& the United Kingdom.

Only patients who are intended to undergo treatment with the OncoSil™ device in the commercial (sales) setting will participate in this Registry.

Every patient who is prescribed OncoSil™ in the commercial setting will be approached by the Treating Physician to consent to participate in the OSPREY Patient Registry.

Patients who choose not to consent to participate in the OSPREY Patient Registry will not be excluded from being treated with the OncoSil™ device.

Five hundred patients (implanted with OncoSil™) will be recruited into the OSPREY Patient Registry. It is anticipated recruitment will be over a five-year period, subject to the rate of commercial adoption of the OncoSil™ device in the market.

To adequately collect data relating to the performance and safety of the OncoSil™ device, data will be collected from patients over a prescribed 12-month period from enrolment, the cohort is then followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™.

Therefore, the Registry is expected to run for a seven-year period. Relevant observational data will be collected via medical record review.

Eligibility criteria: 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 outcomes:
measure: Safety and tolerability of Device
timeFrame: Followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™
measure: Device Implantation Performance
timeFrame: 7 years
measure: Overall Survival
timeFrame: Followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™
measure: tumour response as demonstrated by target tumour response demonstrated by RECIST 1.1
timeFrame: 7 years
measure: Resection Rates
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Las Palmas De Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular Materno-Infantil
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario de Fuenlabrada
city: Madrid
country: Spain
facility: Hospital Universitario Doce De Octobre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Pamplona
country: Spain
facility: Clinica Universidad De Navarra
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario De Valladolid
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: London
country: United Kingdom
facility: The London Clinic
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust, London, UK
name: Paul J Ross, MRCP, MBBS
role: PRINCIPAL_INVESTIGATOR
References: