Assessing optimal treatment settings for the ablation of locally advanced pancreatic cancer with CT-guided percutaneous irreversible electroporation: a randomized feasibility study.

Assessing optimal treatment settings for the ablation of locally advanced pancreatic cancer with CT-guided percutaneous irreversible electroporation: a randomized feasibility study. - ANTILOPE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55702

Enrollment

Registered

2018-03-06

Start date

2018-04-12

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced pancreatic cancer pancreatic adenocarcinoma.

Interventions

Patients with pathology proven LAPC and stable disease after 2 months of chemotherapy (FOLFIRINOX) will be randomized for either CT-guided IRE, with either the Miami settings ), or the Louisville se

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >=18 years - LAPC (either primary or tumour recurrence following resection) - At least RECIST stable disease after 2 months of chemotherapy with FOLFIRINOX - Capable of providing written and oral informed consent - Candidate for IRE, maximum diameter LAPC 5cm

Exclusion criteria

Exclusion criteria: - Participation in PELICAN trial focussing on radiofrequency ablation for LAPC - Eligibility for resection - Bleeding disorders which can not be corrected with medication - Inability/unwillingness to interrupt anticoagulation therapy - WHO 2/3 or ASA 3/4 - ICD/pacemaker - Both partial stenosis of the portal vein and hepatic artery of >50% - Pregnancy - Metastatic pancreatic cancer

Design outcomes

Primary

Measure	Time frame
Feasibility of CT-guided IRE. Primary outcomes after treatment are adverse events and serious adverse events (defined as CTCAE grade >=3 complications), which should not exceed 60%. Mortality should be below 5%.	—

Secondary

Measure	Time frame
Secondary endpoints are thermal injury, treatment duration, overall survival, progression-free survival, difference in serum CA19-9 (area under the curve) during the first 3 months post-IRE, temperature measurements in the treated region during IRE procedure, extent of the ablation zone and treatment efficacy on cross-sectional imaging (CT) 6 and 12 weeks after the procedure, post-intervention serum levels of amylase, lipase, glucose and transaminases, pain score (VAS) and analgesics use during the first three months post-IRE, systemic inflammatory response and continuation of chemotherapy following IRE.	—

Measure

Time frame

Secondary endpoints are thermal injury, treatment duration, overall survival, progression-free survival, difference in serum CA19-9 (area under the curve) during the first 3 months post-IRE, temperature measurements in the treated region during IRE procedure, extent of the ablation zone and treatment efficacy on cross-sectional imaging (CT) 6 and 12 weeks after the procedure, post-intervention serum levels of amylase, lipase, glucose and transaminases, pain score (VAS) and analgesics use during the first three months post-IRE, systemic inflammatory response and continuation of chemotherapy following IRE.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)