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Trial record 1 of 2 for:    COLDFIRE
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Efficacy of Irreversible Electroporation (IRE) for Central Colorectal Liver Metastases (COLDFIRE-2)

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ClinicalTrials.gov Identifier: NCT02082782
Recruitment Status : Unknown
Verified April 2016 by Dr. M.R. Meijerink, Amsterdam UMC, location VUmc.
Recruitment status was:  Recruiting
First Posted : March 10, 2014
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. M.R. Meijerink, Amsterdam UMC, location VUmc

Tracking Information
First Submitted Date  ICMJE March 6, 2014
First Posted Date  ICMJE March 10, 2014
Last Update Posted Date April 29, 2016
Study Start Date  ICMJE May 2014
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
Efficacy [ Time Frame: 12 months ]
The primary objective of this project is to evaluate the efficacy (percentage of lesions that show no sign of recurrence 12 months after the initail IRE procedure) of IRE for CRLM on cross-sectional imaging performed after respectively 6 weeks, and after 3, 6, 9 and 12 months. Research has shown that 95% of all recurrences after RFA of CRLM are diagnosed within one year after treatment. Therefore, one year follow-up will allow for accurate calculation of efficacy. Exact secondary efficacy rate may require follow-up longer than 12 months since this includes lesions that have been re-treated due to local site recurrence/local tumor residue (which will be individualized for each patient after re-treatment of LSR/LTR).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Irreversible Electroporation (IRE) for Central Colorectal Liver Metastases
Official Title  ICMJE Colorectal Metastatic Liver Disease: Efficacy of Irreversible Electroporation (IRE) - a Phase II Clinical Trial (COLDFIRE-2 Study)
Brief Summary

Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are applied to tumorous tissue. These pulses alter the existing transmembrane potential of the cell membranes, and create 'nanopores', after which the cell dies through loss of homeastasis.

The purpose of this study is to investigate the efficacy of percutaneous and open IRE in the treatment of patients with colorectal liver metastases (CRLM) that are unsuitable for resection or thermal ablation due to vicinity to vulnerable structures such as vessels and bile ducts. Other objectives are safety, feasibility (technical success) and imaging characteristics on follow-up (PET-)CT and PET-MRI and the value of these imaging modalities in dianosing local site recurrence (LSR) or residual disease (RD).

29 patients with histologically confirmed colorectal carcinoma who present with unresectable and not thermally ablative CRLM< 3.5cm suitable for IRE will undergo percutaneous or open irreversible electroporation of the tumor using CT and ultrasound guidance. All (serious) adverse events are registered. One day post-IRE MRI is performed to assess technical success. Follow-up will consist of frequent (PET-)CT and (PET-)MRI scanning to localize residual or recurrent disease. Overall technique effectiveness is determined 1 year after treatment.

The investigators hypothesize that IRE for central CRLM will lead to good tumor control without causing severe complications.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Liver Metastases
Intervention  ICMJE Procedure: Irreversible electroporation (IRE)
Percutaneous (CT-guided) or open (US-guided) irreversible electroporation of central colorectal liver metastasis.
Other Name: NanoKnife
Study Arms  ICMJE Experimental: irreversible electroporation (IRE)
Single arm study: percutaneous or open irreversible electropration of CRLM
Intervention: Procedure: Irreversible electroporation (IRE)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 7, 2014)
29
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2018
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histological or cytological documentation of primary colorectal tumor;
  • Previous induction chemotherapy due to unresectability; no intra- or extrahepatic disease progression under induction chemotherapy; OR
  • Previous chemotherapy for other CRLM, now presenting with renewed CRLM unsuitable for resection or thermal ablation;
  • Liver metastases F-18-FDG PET avid and visible on ceCT, size ≤ 3,5 cm and not eligible for resection or thermal ablation due to location close to a vessel or bile duct;
  • Age more than 18 years;
  • ASA classification 0 - 3;
  • 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 bilirubin ≤ 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:

  • Lesion > 3,5 cm size;
  • History of epilepsy;
  • Extrahepatic metastases rendering local therapy unfeasible;
  • History of cardiac disease:

    • Congestive heart failure >NYHA class 2;
    • Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening);
    • Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers 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);
  • Pregnant or breast-feeding subjects;
  • Immunotherapy ≤ 6 weeks prior to the procedure;
  • Chemotherapy ≤ 6 weeks prior to the procedure;
  • Concomitant use of anti-convulsives and anti-arrhythmic drugs other than beta blockers for antiepileptic or antiarrhythmic purpose;
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02082782
Other Study ID Numbers  ICMJE COLDFIRE-2 study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr. M.R. Meijerink, Amsterdam UMC, location VUmc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Amsterdam UMC, location VUmc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Martijn R Meijerink, MD, PhD VU University Medical Center (VUmc)
Principal Investigator: Krijn P van Lienden, MD, PhD Academic Medical Center Amsterdam (AMC)
Principal Investigator: Arian R van Erkel, MD, PhD Leiden University Medical Center (LUMC)
PRS Account Amsterdam UMC, location VUmc
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP