Tests irreversible electroporation with chemotherapy in locally advanced pancreatic cancer
Tests a device-based treatment with chemotherapy in adults with pancreatic cancer that cannot be removed.
Key facts
- Who runs it
- University of Saskatchewan
- Where
- Regina and Saskatoon, CanadaSee the 2 sites
- Trial code
- Registry title
- Systemic Therapy With a Loco-regional Treatment in Patients With Locally Advanced Pancreatic Cancer
- Status
- Recruiting
- People taking part
- 27 people, planned
- Started
- 1 May 2025
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional
- Treatments tested
- Irreversible electroporation (NanoKnife® )
- Record updated
- 13 May 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with biopsy-proven pancreatic cancer that has grown locally but has not spread, who can have chemotherapy. It tests chemotherapy plus irreversible electroporation (IRE).
- Age
- Adults (no exact age range is given in the record).
- Sex
- All sexes can join.
- Disease stage
- Locally advanced pancreatic adenocarcinoma proven by biopsy, not spread to other organs (not metastatic).
- Earlier treatment
- Not stated in the record. Patients must be able to have combination chemotherapy, as decided by their oncologist.
Main reasons for not taking part
- Pregnancy
- Pancreatic cancer that has spread to other organs (metastatic)
- Another active second primary cancer (except squamous cell skin cancer or an in situ cancer)
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- Adult patients with biopsy-proven locally advanced pancreatic adenocarcinoma who are candidates for combination chemotherapy as determined by treating oncologists
Who cannot take part
- Metastatic pancreatic cancer
- Another active second primary cancer with the exception of squamous cell carcinoma of the skin or an in situ cancer
- Pregnancy
Where in Canada
- Allan Blair Cancer CenterRegina, CanadaContact: Haji Chalchal, MDTaking people
- Saskatoon Cancer CenterSaskatoon, CanadaContact: Shahid AhmedTaking people
About the trial
What the trial wants to find out
Background
Read full original descriptionShow less
Pancreatic cancer is one the leading causes of cancer-related death in Canada. Approximately 40 percent of patients with pancreatic cancer present with locally advanced pancreatic cancer and are not candidate for curative surgery. The optimal management of patients with locally advanced pancreatic cancer remains unknown. Most patients are treated with chemotherapy alone and role of local treatment such as radiation is not well defined. Other conventional ablative therapies such as thermal ablation and cryoablation have limited role in locally advanced pancreatic cancer due to the risk of collateral damage to the adjacent structures. Irreversible electroporation (IRE) is a novel non-thermal ablation technology that does not cause injury to nearby blood vessels, ducts, and bowel and has potential to provide longer disease control and thereby a better overall survival. The current study aims to prospectively validate effectiveness and safety of IRE in real-world patients with locally advanced pancreatic cancer.
Objectives
1) To determine 12-month progression-free survival (PFS) and 24-month overall survival rates of patients with locally advanced pancreatic cancer who are treated with combination chemotherapy and IRE and 2) to compare progression-free and overall survival of patients with locally advanced pancreatic cancer who are treated with combination chemotherapy and IRE versus combination chemotherapy alone.
Design
Prospective multicenter single arm study.
Methods
Based on the assumption of doubling of PFS of patients who are being treated with IRE and chemotherapy versus chemotherapy alone we estimated a sample of n=27 of adult patients with histologically proven non-metastatic locally advanced adenocarcinomas. Eligible patients will be recruited at the two major cancer centers in Saskatchewan. All IRE eligible patients will receive 12 weeks of induction chemotherapy and will undergo repeat imaging studies. If there is no disease progression IRE will be performed. An additional 12 weeks of chemotherapy will be recommended. Patients who are not eligible for IRE due to size criteria will receive chemotherapy at the discretion of treating oncologist till disease progression or till they become eligible for IRE. Quality of life will be assessed every three months or until disease progression.
Significance
Despite progress in the management of most solid organ cancers and better outcomes, little advancement has been made in the treatment of patients with locally advanced pancreatic cancer. Unfortunately, most patients have very limited life expectancy. There is an unmet need for novel approaches in the management of patients with locally advanced pancreatic cancer. IRE in combination with chemotherapy has potential to improve local disease control and thereby improves survival and may prove a valuable tool to add in the multidisciplinary treatment of cancer. The result of this study will be used for the development of a future multicenter national phase III trials.
The group in the trial
- Single arm studyOther group
All eligible patients will receive combination chemotherapy and if there i s a positive response they will undergo IRE.
Treatment: Irreversible electroporation (NanoKnife® )
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Systemic Therapy With a Loco-regional Treatment in Patients With Locally Advanced Pancreatic Cancer: The SMART Study
- Plain-language title
- Tests irreversible electroporation with chemotherapy in locally advanced pancreatic cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 13 May 2025