Safety and feasibility of CT-guided percutaneous radionuclide therapy with the OncoSil* device in patients with non-progressive locally advanced pancreatic cancer (PANCOSIL): an open-label, single-arm phase 1-2 feasibility study

Phase 2

• Conditions: Locally Advanced Pancreatic Cancer; Unresectable Pancreatic Cancer; 10017991; 10017998

• Registration Number: NL-OMON54345
• Lead Sponsor: Amsterdam UMC, locatie AMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- Age >=18 years
- Locally advanced pancreatic cancer, defined by the DPCG consensus criteria
as: arterial involvement >90* or venous involvement >270*.
- At least RECIST stable disease after a minimum two months of chemotherapy
according to current clinical practice*
- Capable of providing written and oral informed consent
- Candidate for RNT, judged by a multidisciplinary tumor board
- WHO 0-2

* FOLFIRINOX for patients with WHO 0-1 performance status and
gemcitabine-nab-paclitaxel for patients with > 1-2performance status.

Exclusion Criteria

- Eligibility for resection
- Participation in other trials focussing on different ablative treatment
modalities such as radiofrequency ablation or irreversible electroporation for
LAPC
- Bleeding disorders which cannot be corrected with medication
- Inability/unwillingness to interrupt anticoagulation therapy
- ASA 3/4
- Pregnancy
- Metastatic pancreatic cancer
- Epilepsy episode(s) in the past six months
- Longest tumor diameter >70 mm or total target tumor volume >110 ml
- Presence of multiple collateral vessels surrounding or adjacent to the target
tumor on radiologic imagining, prohibiting safe injection of the OncosilTM
device
- Presence (or significant risk) of varices near the target tumor on radiologic
imaging
- Recent clinically significant pancreatitis
- Previous administration of radiotherapy to the pancreas
- WHO > 2

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety and feasibility of percutaneous RNT using the Oncosil* device defined by<br /><br>the percentage of complications CTCAE grade 3 or higher.</p><br>