ID
Bron
Verkorte titel
Aandoening
Pancreatic cancer; locally advanced pancreatic cancer; LAPC
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary endpoint is treatment time of CT-guided IRE.
Achtergrond van het onderzoek
Pancreatic ductal adenocarcinoma (i.e. pancreatic cancer) is one of the leading causes of
cancer-related deaths worldwide. For the 40% of patients who present with non-metastatic locally
advanced (unresectable) disease, CT-guided percutaneous irreversible electroporation (IRE) has provided promising results but confirmation from randomized controlled trials (RCTs) are lacking. Before largescale RCTs can be designed, data from smaller, randomized feasibility studies are required to determine which of the IRE protocols should be used. The aim of this study is therefore to compare the two most frequently used clinical IRE protocols including state-of-the-art chemotherapy in locally advanced pancreatic cancer (LAPC).
Onderzoeksopzet
March 2018 start inclusinon, expected duration 2-2.5 years. Expected last inclusion: September 2020.
Onderzoeksproduct en/of interventie
Eligible patients will be randomized for IRE either with the Fixed Amperage or the Targeted Amperage protocol. IRE will be performed under general anaesthesia with full muscle relaxation. Chemotherapy, follow-up including imaging will all be performed according to standard care.
Publiek
ADDRESS G04.196
Marc G.H. Besselink
Amsterdam 1100 DD
The Netherlands
+31 (0) 20 5669111
m.g.besselink@amc.nl
Wetenschappelijk
ADDRESS G04.196
Marc G.H. Besselink
Amsterdam 1100 DD
The Netherlands
+31 (0) 20 5669111
m.g.besselink@amc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age ≥18 years
- LAPC (either primary or tumour recurrence following resection), defined by the DPCG consensus criteria as: arterial involvement >90 or venous involvement >270)
- At least RECIST stable disease after at least 2 months of chemotherapy according to current clinical practice
- Capable of providing written and oral informed consent
- Candidate for IRE, maximum diameter of the tumour 5cm
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Participation in the PELICAN trial focussing on radiofrequency ablation for LAPC*
- Eligibility for resection
- Bleeding disorders which cannot be corrected with medication
- Inability/unwillingness to interrupt anticoagulation therapy
- ASA 3/4
- ICD/pacemaker incompatible with IRE
- Both partial stenosis of the portal vein and hepatic artery of >50%
- Pregnancy
- Metastatic pancreatic cancer
- Presence of a uncovered metal biliary stent in the IRE field
- Tumour with a maximum diameter >5cm
- Epilepsy episodes in the past 6 months
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7015 |
| NTR-old | NTR7213 |
| CCMO | NL59644.018.17 |
| OMON | NL-OMON55702 |