Electroporation (NanoKnife) as Treatment for Advanced Pancreatic Cancer (NanoKnife)
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|ClinicalTrials.gov Identifier: NCT02079623|
Recruitment Status : Unknown
Verified March 2014 by Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery, Aalborg University Hospital.
Recruitment status was: Enrolling by invitation
First Posted : March 6, 2014
Last Update Posted : March 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Procedure: Electroporation/ Nano knife treatment Device: NanoKnife||Phase 3|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Implementation of Electroporation - NanoKnife as Treatment for Advanced Pancreatic Cancer.|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||November 2015|
|Estimated Study Completion Date :||November 2015|
Patients with locally advanced pancreatic cancer.
Procedure: Electroporation/ Nano knife treatment
- Tumor response [ Time Frame: 24 months follow-up ]According to RECIST criteria (PET-CT)
- CA-19-9 [ Time Frame: 24 months follow up ]CA-19-9 measurement every 3 months
- Overall survival [ Time Frame: 24 months follow-up ]
- Pain registration [ Time Frame: 24 months follow up ]Pain registration pre- and post nano knife treatment (VAS-score).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079623
|Surgical Department of Gastroenterology, Aalborg University Hospital|
|Aalborg, Nothern Jutland, Denmark, 9000|
|Study Chair:||Ole Thorlacius-Ussing, Prof., cons., dr. med||Department of Gastroinstestinal Surgery, Aalborg University Hospital|