PANFIRE - Pilot-study: Non-thermal ablation using Irreversible Electroporation (IRE) to treat locally advanced pancreatic carcinoma - a phase I clinical study

Phase 2

Recruiting

Conditions: 10015674
10003018
locally advanced pancreatic carcinoma
synonyme: inoperable pancreatic cancer without metastases
10017991

Registration Number: NL-OMON41424

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Screening must be performed no longer than 2 weeks prior to study inclusion. Subjects are eligible if they meet the following criteria:;* Histologic or cytologic confirmation of primary pancreatic carcinoma;
* Radiologic confirmation of unresectable pancreatic carcinoma without distant metastases by at least ceCT of chest and abdomen, performed maximum 2 weeks prior to the procedure;
* Maximum tumor diameter * 5 cm;
* Age * 18 years;
* ASA-classificaton 0 * 3;
* Life expectancy of at least 12 weeks;
* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to definite inclusion;
- Hemoglobin * 5.6 mmol/L;
- Absolute neutrophil count (ANC) * 1,500/mm3;
- Platelet count * 100*109/l;
- Total bilirubine * 1.5 times the upper limit of normal (ULN);
- ALT and AST * 2.5 x ULN;
- Serum creatinine * 1.5 x ULN or a calculated creatinine clearance * 50 ml/min;
- Prothrombin time or INR < 1.5 x ULN;
- Activated partial thromboplastin time < 1.25 x ULN (therapeutic anticoagulation therapy is
allowed if this treatment can be interrupted as judged by the treating physician);
* Written informed consent;

Exclusion Criteria

Subjects who meet the following criteria at the time of screening will be excluded:
* Resectable pancreatic adenocarcinoma as discussed by our multidisciplinary hepatobiliary team;
* Extrapancreatic metastases;
* Successful downstaging after (radio)chemotherapy from previous unresectable/borderline tumor to resectable tumor;
* History of epilepsy;
* History of cardiac disease:
- Congestive heart failure >NYHA class 2;
- Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to
screening);
- Ventricular cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers for antihypertensive regimen are permitted);
* Uncontrolled hypertension. Blood pressure must be *160/95 mmHg at the time of screening on a stable antihypertensive regimen;
* Compromised liver function (e.g. signs of portal hypertension, INR > 1,5 without use of anticoagulants, ascites);
* Uncontrolled infections (> grade 2 NCI-CTC version 3.0);
* Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment;
* Immunotherapy * 6 weeks prior to the procedure;
* Chemotherapy * 6 weeks prior to the procedure;
* Radiotherapy * 6 weeks prior to the procedure;
* Concomitant use of anti-convulsive and anti-arrhythmic drugs (other than beta blockers for hypertension);
* Allergy to contrast media;
* Any implanted stimulation device;
* Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome of the study is the safety of IRE for the treatment of locally<br /><br>advanced pancreatic carcinoma, By registration and analysis of adverse events<br /><br>and serious adverse events, incidence and severity of complications within 90<br /><br>days after the intervention are investigated and morbidity and mortality will<br /><br>be determined. Late complications that might be related to the intervention<br /><br>(listed in the study protocol under paragraph 12.1), will always be registered<br /><br>and reported if necessary (in case of SAE's). These results will be compared to<br /><br>patients that have undergone radio- and or chemotherapy alone. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are (see paragraph 2.1.2. from the project protocol):<br /><br><br /><br>- Feasibility: parameters are willingness of patients to participate, number of<br /><br>eligible patients, total procedure time, ablation time, number of tme of<br /><br>replacement of the electrodes (expressed in learning curve)<br /><br><br /><br>-Efficacy, as expressed in:<br /><br>1. Symptomatic response: Quality of life, pain registration and pain medication<br /><br>and general performance status<br /><br>2. Tumor evaluation: Size and shape of the ablation area, ablation success and<br /><br>local recurrence rate (by CT and MRI)<br /><br><br /><br>- Immunologic response: by investigating the T-cell specific immune reaction,<br /><br>before, 2 weeks and 3 months after IRE.<br /><br><br /><br>- Exocrine pancreatic function, smaal bowel absorption capacity and body fat<br /><br>composition </p><br>