Status:
SUSPENDED
A Clinical Study of EUS-RFA for Inoperable Pancreatic Ductal Adenocarcinoma
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To assess if endoscopic ultrasound-guided radiofrequency ablation application in patients with inoperable pancreatic cancer confers survival benefit when compared to patients receiving standard medica...
Detailed Description
The five-year survival for pancreatic ductal adenocarcinoma (PDAC) is less than 5% in spite of the advances in management of cancers in the last few decades. Endobiliary application of radiofrequency ...
Eligibility Criteria
Inclusion
- Patients above 18 years of age.
- A cytological / histological diagnosis of inoperable PDAC based on multidisciplinary review of cross-sectional imaging and cytology / histology results.
- Patients ought to be fit enough to be considered for the study (ECOG (Eastern Cooperative Oncology Group) performance status 0, 1 or 2)
- Patients who have commenced chemotherapy are not excluded from the study
- Patients capable of giving informed consent
- Negative blood pregnancy test for women of childbearing potential
- Willingness and ability to comply with all protocol requirements including scheduled visits, treatment plans, laboratory tests and other study procedures.
Exclusion
- ECOG performance status 3 or 4
- Life expectancy less than 3 months (including liver metastases, carcinomatosis)
- Prior investigational drugs within the last 30 days
- Known infection with human immunodeficiency virus (HIV)
Key Trial Info
Start Date :
February 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT03444948
Start Date
February 14 2019
End Date
December 1 2028
Last Update
June 20 2024
Active Locations (1)
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1
Centre de recherche du Centre hospitalier de l'université de Montréal
Montreal, Quebec, Canada, H2X 0A9