Systemic Therapy With a Loco-regional Treatment in Patients With Locally Advanced Pancreatic Cancer

NCT04276857 | Recruiting

• 1 other identifier: 284
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

Background 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.

Conditions

Locally Advanced Pancreatic Cancer; Irreversible Electroporation

Outcome Measures

Primary Outcomes (1)

• 1 year progression free survival rate of patients with locally advanced pancreatic cancer who are treated with IRE and combination chemotherapy.

  Progression free survival

  At 12 months after enrollment into the study

Secondary Outcomes (8)

• 2 years overall survival rate of patients with locally advanced pancreatic cancer who are treated with IRE and combination chemotherapy.

  At 2 years after enrollment into the study

• quality of life of patients with locally advanced pancreatic cancer who are treated with combination chemotherapy and IRE: EORTC QOL 30

  Every 3 months

• 12 and 24 months rate of IRE in patients with locally advanced pancreatic cancer who are initially deemed to be ineligible for IRE.

  At 12 and 24 months

• 30-day and 90-day complications rate of IRE.

  30 and 90 days

• cost-effectiveness of IRE in patients with locally advanced pancreatic cancer.

  At 2 years

Study Arms (1)

Single arm study

OTHER

All eligible patients will receive combination chemotherapy and if there i s a positive response they will undergo IRE.

Device: Irreversible electroporation (NanoKnife® )

Interventions

Irreversible electroporation (NanoKnife® ) DEVICE

IRE is a unique treatment modality as it ablates tumor cells without using heat or radiation and hence does not cause injury to nearby blood vessels, ducts, and bowel. This makes it particularly appealing for the treatment of locally advanced unresectable pancreatic cancers. This local treatment for cancer involves delivering brief pulses of high voltage electrical current across the tumor (either percutaneously or open surgery), which results in the formation of tiny holes (nanopores) in the cell membranes.

Also known as: FOLFIRINOX (5-FU, leucovorin, irinotecan, and oxaliplatin) or gemcitabine/nab-paclitaxel

Single arm study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with biopsy-proven locally advanced pancreatic adenocarcinoma who are candidates for combination chemotherapy as determined by treating oncologists.

You may not qualify if:

• Pregnancy
• Metastatic pancreatic cancer
• Another active second primary cancer with the exception of squamous cell carcinoma of the skin or an in situ cancer.

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (2)

Allan Blair Cancer Center

Regina, Saskatchewan, Canada

RECRUITING

Saskatoon Cancer Center

Saskatoon, Saskatchewan, S7N4H4, Canada

RECRUITING

Related Publications (16)

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  BACKGROUND

• Canadian Cancer Statistics 2016. http://www.cancer.ca/~/media/cancer.ca/CW/cancer%20information/cancer%20101/Canadian%20cancer%20statistics/Canadian-Cancer-Statistics-2016-EN.pdf?la=en (Accessed on July 13th, 2017).

  BACKGROUND

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  PMID: 27247216 BACKGROUND

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• Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

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  PMID: 24131140 BACKGROUND

• Papneja N, Zaidi A, Chalchal H, Moser M, Tan K, Olson C, Haider K, Shaw J, Ahmed S. Comparisons of Outcomes of Real-World Patients With Advanced Pancreatic Cancer Treated With FOLFIRINOX Versus Gemcitabine and Nab-Paclitaxel: A Population-Based Cohort Study. Pancreas. 2019 Aug;48(7):920-926. doi: 10.1097/MPA.0000000000001340.

  PMID: 31180981 BACKGROUND

• Hammel P, Huguet F, van Laethem JL, Goldstein D, Glimelius B, Artru P, Borbath I, Bouche O, Shannon J, Andre T, Mineur L, Chibaudel B, Bonnetain F, Louvet C; LAP07 Trial Group. Effect of Chemoradiotherapy vs Chemotherapy on Survival in Patients With Locally Advanced Pancreatic Cancer Controlled After 4 Months of Gemcitabine With or Without Erlotinib: The LAP07 Randomized Clinical Trial. JAMA. 2016 May 3;315(17):1844-53. doi: 10.1001/jama.2016.4324.

  PMID: 27139057 BACKGROUND

• Deipolyi AR, Golberg A, Yarmush ML, Arellano RS, Oklu R. Irreversible electroporation: evolution of a laboratory technique in interventional oncology. Diagn Interv Radiol. 2014 Mar-Apr;20(2):147-54. doi: 10.5152/dir.2013.13304.

  PMID: 24412820 BACKGROUND

• Ruarus AH, Vroomen LGPH, Puijk RS, Scheffer HJ, Zonderhuis BM, Kazemier G, van den Tol MP, Berger FH, Meijerink MR. Irreversible Electroporation in Hepatopancreaticobiliary Tumours. Can Assoc Radiol J. 2018 Feb;69(1):38-50. doi: 10.1016/j.carj.2017.10.005.

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  PMID: 25787829 BACKGROUND

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  PMID: 26258317 BACKGROUND

• Narayanan G, Hosein PJ, Beulaygue IC, Froud T, Scheffer HJ, Venkat SR, Echenique AM, Hevert EC, Livingstone AS, Rocha-Lima CM, Merchan JR, Levi JU, Yrizarry JM, Lencioni R. Percutaneous Image-Guided Irreversible Electroporation for the Treatment of Unresectable, Locally Advanced Pancreatic Adenocarcinoma. J Vasc Interv Radiol. 2017 Mar;28(3):342-348. doi: 10.1016/j.jvir.2016.10.023. Epub 2016 Dec 16.

  PMID: 27993507 BACKGROUND

MeSH Terms

Interventions

Electroporation

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Shahid Ahmed, MD, PhD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahid Ahmed, MD, PhD

CONTACT

3066122617; shahid.ahmed@saskcancer.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: February 19, 2020
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

CA (2)