NCT02079623

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

5.5 years

First QC Date

March 4, 2014

Last Update Submit

January 8, 2020

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancerElectroporationNano knife treatment

Outcome Measures

Primary Outcomes (1)

  • Tumor response

    According to RECIST criteria (PET-CT)

    24 months follow-up

Secondary Outcomes (2)

  • CA-19-9

    24 months follow up

  • Overall survival

    24 months follow-up

Other Outcomes (1)

  • Pain registration

    24 months follow up

Study Arms (1)

Pancreatic cancer

Patients with locally advanced pancreatic cancer.

Procedure: Electroporation/ Nano knife treatmentDevice: NanoKnife

Interventions

Electroporation/ Nano knife treatmentPROCEDURE
Pancreatic cancer
NanoKnifeDEVICE
Pancreatic cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with locally advanced pancreatic cancer

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surgical Department of Gastroenterology, Aalborg University Hospital

Aalborg, Nothern Jutland, 9000, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Cytological TechniquesClinical Laboratory TechniquesInvestigative TechniquesElectrochemical Techniques

Study Officials

  • Ole Thorlacius-Ussing, Prof., cons., dr. med

    Department of Gastroinstestinal Surgery, Aalborg University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DMSc, Professor of Surgery

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 6, 2014

Study Start

November 1, 2013

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

January 10, 2020

Record last verified: 2020-01

Locations

DK(1)