- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02079623
Electroporation (NanoKnife) as Treatment for Advanced Pancreatic Cancer (NanoKnife)
Implementation of Electroporation - NanoKnife as Treatment for Advanced Pancreatic Cancer.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nothern Jutland
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Aalborg, Nothern Jutland, Denmark, 9000
- Surgical Department of Gastroenterology, Aalborg University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients above 18 years old, who have given informed consent to treatment with electroporation
- Performance status <= 2 and meets one of the items below
- Patients diagnosed with LAPC, who are not candidate to primary curative surgical treatment due to tumor invasion in surrounding blood vessels or adjacent organs
- Patients, who have received oncological treatment with the aim of downstaging and the tumor still is deemed none-resectable
Exclusion Criteria:
- Patients with pacemaker or similar electrostimulator (TNS, anal sphincter stimulators ect.)
- Patients for whom the anesthesia involves high risk (ASA- IV)
- Estimated survival of less than 3 months
- Metallic stent in the biliary tract, which can not be removed or changed to plastic stent.
- Performance status > 2.
- Pregnancy
- Epilepsy or other condition involving convulsions
- Inability to give informed consent.
- Patients with inability to cooperate for treatment and follow-up
- Severe heart disease
- Patients with a tumor larger than 5 cm.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pancreatic cancer
Patients with locally advanced pancreatic cancer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor response
Time Frame: 24 months follow-up
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According to RECIST criteria (PET-CT)
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24 months follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CA-19-9
Time Frame: 24 months follow up
|
CA-19-9 measurement every 3 months
|
24 months follow up
|
Overall survival
Time Frame: 24 months follow-up
|
24 months follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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24 months follow up
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Ole Thorlacius-Ussing, Prof., cons., dr. med, Department of Gastroinstestinal Surgery, Aalborg University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCaNanoK
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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