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Trial record 53 of 2865 for:    Pancreatic Cancer AND pancreas

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
Sponsor:
Collaborator:
Uppsala University Hospital
Information provided by (Responsible Party):
Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery, Aalborg University Hospital

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Procedure: Electroporation/ Nano knife treatment Device: NanoKnife Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Pancreatic cancer
Patients with locally advanced pancreatic cancer.
Procedure: Electroporation/ Nano knife treatment
Device: NanoKnife



Primary Outcome Measures :
  1. Tumor response [ Time Frame: 24 months follow-up ]
    According to RECIST criteria (PET-CT)


Secondary Outcome Measures :
  1. CA-19-9 [ Time Frame: 24 months follow up ]
    CA-19-9 measurement every 3 months

  2. Overall survival [ Time Frame: 24 months follow-up ]

Other Outcome Measures:
  1. Pain registration [ Time Frame: 24 months follow up ]
    Pain registration pre- and post nano knife treatment (VAS-score).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Denmark
Surgical Department of Gastroenterology, Aalborg University Hospital
Aalborg, Nothern Jutland, Denmark, 9000
Sponsors and Collaborators
Aalborg University Hospital
Uppsala University Hospital
Investigators
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Study Chair: Ole Thorlacius-Ussing, Prof., cons., dr. med Department of Gastroinstestinal Surgery, Aalborg University Hospital

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Responsible Party: Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery, MD, DMSc, Professor of Surgery, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT02079623     History of Changes
Other Study ID Numbers: PCaNanoK
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: March 6, 2014
Last Verified: March 2014
Keywords provided by Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery, Aalborg University Hospital:
Pancreatic cancer
Electroporation
Nano knife treatment
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases