Pancreatic Ductal AdenocarcinomaNCT03257150
A Study of the Use of Irreversible Electroporation in Pancreatic Ductal Cancer
A study testing Irreversible Electroporation and NanoKnife System in people with Pancreatic Ductal Adenocarcinoma, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This I/II study will evaluate to see how safe and useful irreversible electroporation (also called NanoKnife) is in patients with locally advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Irreversible Electroporation and NanoKnife System
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 22 Sep 2017to 14 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven pancreatic ductal adenocarcinoma (PDAC)
- Age ≥ 18 years
- Locally advanced unresectable primary tumor
- Tumors ≤5 cm in largest dimension at the time of enrollment that is technically amenable to treatment with irreversible electroporation (IRE)
- At least 4 months of combination chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
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- Acceptable organ and bone marrow function
- Life expectancy estimated ≥6 months
- Ability and willingness to sign informed consent form
- Have a measurable primary tumor at the time of study enrollment
- Suitable and fit to undergo general anesthetic and laparotomy
- Women of child-producing potential must agree to use effective contraceptive methods prior to study entry, during study participation, and for at least 30 days after the last administration of study medication.
Who cannot join
- Stage IV (i.e. metastatic) PDAC
- Have a cystic subtype PDAC of the pancreas
- Previous local treatments for locally advanced PDAC including IRE or radiotherapy
- Recent or concurrent cancer, that is distinct from PDAC in primary site/histology, except cervical carcinoma in situ, localized prostate cancer, treated basal cell carcinoma, superficial bladder tumours (Ta, Tis \& T1) and those that can be permitted with sufficient clinical justification confirming patient safety to undergo the procedure per Principle Investigator and is in the best interest of the patient. Cancer curatively treated ≥3 years prior to entry is permitted.
- Prior chemotherapy within 3 years of diagnosis of PDAC. Chemotherapy for PDAC is permitted
- Direct invasion of locally advanced PDAC into the stomach or duodenum
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- Metallic biliary stent that cannot be substituted with a plastic stent
- Allergy to computed tomography (CT) or magnetic resonance imaging (MRI) contrast that cannot be safely managed with premedication which preclude assessment and/or surveillance of PDAC
- History of cardiac disease (including, but not limited to: congestive heart failure, active coronary artery disease, uncontrolled hypertension)
- Any active major medical illnesses of the respiratory or immune system, or other conditions that may affect patient's ability to tolerate general anesthesia and IRE therapy on this trial
- History of solid organ transplantation or collagen vascular disease
- Medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Pregnant or breast feeding women
- Pre-menopausal women unwilling to take a pregnancy test
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g.: infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc.)
- History of human immunodeficiency virus (HIV) infection
- Progression of the primary lesion as judged by the Investigator
- Working knowledge of English is a must in order to complete the quality of life questionnaires being administered in this study. Patients who do not meet this requirement will be exempt from the quality of life assessments but remain eligible for all other components of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Irreversible Electroporation for Locally Advanced Pancreatic Ductal Adenocarcinoma (LEAP TRIAL): A Phase I/II Prospective Trial
This I/II study will evaluate to see how safe and useful irreversible electroporation (also called NanoKnife) is in patients with locally advanced pancreatic cancer.
Read the detailed description
In this phase I/II trial, patients with locally advanced pancreatic ductal carcinoma will be assigned to receive interventional treatment of irreversible electroporation (IRE).
IRE will be performed by laparotomy under general anesthesia in the operating room.
All patients enrolled in the study will have a biopsy at the time of laparotomy. Blood will be collected for regular blood tests and correlative studies at baseline and during the study. Computed tomography (CT) scans will be done at baseline, 4 weeks post treatment, 12 weeks, 24 weeks, and 36 weeks follow up. Quality of Life (QOL) questionnaires will be completed at baseline and during the study. Patients will be given optional consent for storage of any leftover tissue and blood samples for future analysis. Patients will be followed up 4 weeks post treatment, then every 12 weeks until death.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- Irreversible Electroporation, NanoKnife System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irreversible ElectroporationProcedure or surgery
Irreversible electroporation (IRE) is a process that uses the NanoKnife system to sent electrical currents to a cancer tumor which will disrupt the tumor cell and therefore causing the cell to die. Eligible patients will undergo in situ IRE performed via laparotomy surgery.
NanoKnife SystemDevice
A system consisting of electrode probes connected to a machine. The probes will be surgically placed around the tumor.
| Study group | Role | What they receive |
|---|---|---|
| Study Treatment | Experimental | Single arm trial of irreversible electroporation using the NanoKnife system for locally advanced pancreatic ductal adenocarcinoma. Receives: Procedure: Irreversible Electroporation; Device: NanoKnife System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event rate
Measured: 30 days post IRE or index hospitalization
Overall survival rate
Measured: Date of IRE treatment to the date of death, up to 2 years
Secondary outcomes (3)
Progression-free survival rate
Measured: IRE treatment to the date of documented disease progression or death, up to 2 years
Overall survival rate of disease
Measured: Date of disease diagnosis to date of death, up to 2 years
Progression-free survival rate of disease
Measured: Date of disease diagnosis to date of death, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start22 Sep 2017
- Primary completion14 Jul 2022
- Study completion14 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Gallinger, MD, Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257150
- Sponsor's protocol ID
- LEAP
- Status last verified
- Aug 2022
- First submitted
- 9 Aug 2017
- Last updated
- 11 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irreversible Electroporation for Locally Advanced Pancreatic Ductal Adenocarcinoma (LEAP TRIAL): A Phase I/II Prospective Trial
- ClinicalTrials.gov ID
- NCT03257150
- Acronym / sponsor ID
- LEAP
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 14 Jul 2022 (actual)
- Study completion
- 14 Jul 2022 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This I/II study will evaluate to see how safe and useful irreversible electroporation (also called NanoKnife) is in patients with locally advanced pancreatic cancer.
Detailed description
In this phase I/II trial, patients with locally advanced pancreatic ductal carcinoma will be assigned to receive interventional treatment of irreversible electroporation (IRE).
IRE will be performed by laparotomy under general anesthesia in the operating room.
All patients enrolled in the study will have a biopsy at the time of laparotomy. Blood will be collected for regular blood tests and correlative studies at baseline and during the study. Computed tomography (CT) scans will be done at baseline, 4 weeks post treatment, 12 weeks, 24 weeks, and 36 weeks follow up. Quality of Life (QOL) questionnaires will be completed at baseline and during the study. Patients will be given optional consent for storage of any leftover tissue and blood samples for future analysis. Patients will be followed up 4 weeks post treatment, then every 12 weeks until death.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Treatment | Experimental | Procedure: Irreversible Electroporation, Device: NanoKnife SystemSingle arm trial of irreversible electroporation using the NanoKnife system for locally advanced pancreatic ductal adenocarcinoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically proven pancreatic ductal adenocarcinoma (PDAC)
- Age ≥ 18 years
- Locally advanced unresectable primary tumor
- Tumors ≤5 cm in largest dimension at the time of enrollment that is technically amenable to treatment with irreversible electroporation (IRE)
- At least 4 months of combination chemotherapy
Key exclusion criteria (18 listed)
- Stage IV (i.e. metastatic) PDAC
- Have a cystic subtype PDAC of the pancreas
- Previous local treatments for locally advanced PDAC including IRE or radiotherapy
- Recent or concurrent cancer, that is distinct from PDAC in primary site/histology, except cervical carcinoma in situ, localized prostate cancer, treated basal cell carcinoma, superficial bladder tumours (Ta, Tis \& T1) and those that can be permitted with sufficient clinical justification confirming patient safety to undergo the procedure per Principle Investigator and is in the best interest of the patient. Cancer curatively treated ≥3 years prior to entry is permitted.
- Prior chemotherapy within 3 years of diagnosis of PDAC. Chemotherapy for PDAC is permitted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irreversible ElectroporationIrreversible electroporation (IRE) is a process that uses the NanoKnife system to sent electrical currents to a cancer tumor which will disrupt the tumor cell and therefore causing the cell to die. Eligible patients will undergo in situ IRE performed via laparotomy surgery. | Procedure or surgery | Study Treatment |
| NanoKnife SystemA system consisting of electrode probes connected to a machine. The probes will be surgically placed around the tumor. | Device | Study Treatment |
Primary outcome
Adverse event rate
Time frame: 30 days post IRE or index hospitalization
Overall survival rate
Time frame: Date of IRE treatment to the date of death, up to 2 years
3 secondary outcomes
Progression-free survival rate
Time frame: IRE treatment to the date of documented disease progression or death, up to 2 years
Overall survival rate of disease
Time frame: Date of disease diagnosis to date of death, up to 2 years
Progression-free survival rate of disease
Time frame: Date of disease diagnosis to date of death, up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Gallinger, MD principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irreversible Electroporation and NanoKnife System in people with Pancreatic Ductal Adenocarcinoma, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event rate (time frame: 30 days post IRE or index hospitalization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.