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Electroporation (NanoKnife) as Treatment for Advanced Pancreatic Cancer (NanoKnife)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02079623
Recruitment Status : Completed
First Posted : March 6, 2014
Last Update Posted : January 10, 2020
Sponsor:
Collaborator:
Uppsala University Hospital
Information provided by (Responsible Party):
Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery, Aalborg University Hospital

Tracking Information
First Submitted Date March 4, 2014
First Posted Date March 6, 2014
Last Update Posted Date January 10, 2020
Actual Study Start Date November 2013
Actual Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 5, 2014)
Tumor response [ Time Frame: 24 months follow-up ]
According to RECIST criteria (PET-CT)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02079623 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 5, 2014)
  • CA-19-9 [ Time Frame: 24 months follow up ]
    CA-19-9 measurement every 3 months
  • Overall survival [ Time Frame: 24 months follow-up ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 8, 2020)
Pain registration [ Time Frame: 24 months follow up ]
Pain registration pre- and post NanoKnife treatment using the visual analogue scale of 0 to 10. Higher numbers refer to worse pain.
Original Other Pre-specified Outcome Measures
 (submitted: March 5, 2014)
Pain registration [ Time Frame: 24 months follow up ]
Pain registration pre- and post nano knife treatment (VAS-score).
 
Descriptive Information
Brief Title Electroporation (NanoKnife) as Treatment for Advanced Pancreatic Cancer
Official Title Implementation of Electroporation - NanoKnife as Treatment for Advanced Pancreatic Cancer.
Brief Summary The aim for this study is to implement electroporation therapy (NanoKnife) treatment for patients with locally advanced pancreatic cancer. Electroporation therapy (NanoKnife) will be given in addition to standard chemotherapy.
Detailed Description

Pancreatic cancer has a very high mortality with a 5-year survival rate of less than 10 %. Even though pancreatic cancer accounts for only 2-3 % of all cancer cases, it is the 4th leading cause of cancer death. The best prognosis is observed in patients, where tumor is confined to pancreas, and where curative resection is feasible. This accounts for 5-12% of patients. After complete surgical resection, these patients have a median survival of 15-25 months and a 5-year survival rate of 8-15%. Approximately 40% of patients with pancreatic cancer have metastatic disease at time of diagnosis, a significantly worse prognosis with a median survival of 6-12 months and very low long-term survival (less than 1%). The remaining 40-50% of patients have locally advanced disease (LAPC) without metastases. It is not possible to do complete surgical resection of LAPC because the tumor is infiltrating the surrounding tissue or blood vessel. These patients also have a severe prognosis with a poor long-term survival and median survival time of approximately 12 months.

The majority of patients with LAPC are offered palliative chemotherapy as standard treatment. Few patients are offered downstaging with chemo-radiotherapy. In rare cases downstaging results in extensively tumor shrink which enables subsequently surgical resection. However, the majority of patients remain none-resectable and only candidates for palliative/symptomatic treatment.

Electroporation is a new local treatment of tumors. Tumor cells are exposed to series of direct current impulses with high voltage (1500 V / cm) of milliseconds duration. Electroporation was originally used to enhance the sensitivity of tumor cells to certain cytotoxic agents by increasing the permeability of the cell membrane. Later it was found that direct current at sufficiently high voltage can destroy the cell membrane of cancer cells without damaging surrounding connective tissue or blood vessels. By modulating the length of the impulses and voltage, this cell-killing effect is achieved without any significant heating of the tissue, which reduces the risk of thermal damage. Electroporation differs in this way from other forms of local treatment such as radiofrequency ablation (RFA), which acts through the heating and coagulation of tissue.

The aim for this study is to implement electroporation therapy (NanoKnife) treatment for patients with locally advanced pancreatic cancer. Electroporation therapy (NanoKnife) will be given in addition to standard chemotherapy.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood samples
Sampling Method Non-Probability Sample
Study Population Patients diagnosed with locally advanced pancreatic cancer
Condition Pancreatic Cancer
Intervention
  • Procedure: Electroporation/ Nano knife treatment
  • Device: NanoKnife
Study Groups/Cohorts Pancreatic cancer
Patients with locally advanced pancreatic cancer.
Interventions:
  • Procedure: Electroporation/ Nano knife treatment
  • Device: NanoKnife
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 8, 2020)
33
Original Actual Enrollment
 (submitted: March 5, 2014)
25
Actual Study Completion Date May 1, 2019
Actual Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patients above 18 years old, who have given informed consent to treatment with electroporation
  2. Performance status <= 2 and meets one of the items below
  3. Patients diagnosed with LAPC, who are not candidate to primary curative surgical treatment due to tumor invasion in surrounding blood vessels or adjacent organs
  4. Patients, who have received oncological treatment with the aim of downstaging and the tumor still is deemed none-resectable

Exclusion Criteria:

  1. Patients with pacemaker or similar electrostimulator (TNS, anal sphincter stimulators ect.)
  2. Patients for whom the anesthesia involves high risk (ASA- IV)
  3. Estimated survival of less than 3 months
  4. Metallic stent in the biliary tract, which can not be removed or changed to plastic stent.
  5. Performance status > 2.
  6. Pregnancy
  7. Epilepsy or other condition involving convulsions
  8. Inability to give informed consent.
  9. Patients with inability to cooperate for treatment and follow-up
  10. Severe heart disease
  11. Patients with a tumor larger than 5 cm.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT02079623
Other Study ID Numbers PCaNanoK
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement Not Provided
Responsible Party Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery, Aalborg University Hospital
Study Sponsor Aalborg University Hospital
Collaborators Uppsala University Hospital
Investigators
Study Chair: Ole Thorlacius-Ussing, Prof., cons., dr. med Department of Gastroinstestinal Surgery, Aalborg University Hospital
PRS Account Aalborg University Hospital
Verification Date January 2020