Clinical trial NCT03444948: A Clinical Study of EUS-RFA for Inoperable Pancreatic Ductal Adenocarcinoma
Official title: A Phase II Prospective Randomised Clinical Study of Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Inoperable Pancreatic Ductal Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Pancreatic Ductal Adenocarcinoma
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 medical care.

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 (RF) has been developed and used in patients with inoperable bile duct and pancreatic head adenocarcinomas presenting with biliary obstruction. (1, 2) Endoscopic ultrasound (EUS) radiofrequency ablation (RFA) of pancreatic neoplasms has been proven to be well tolerated and safe, inducing a significant reduction in tumour size (3). Various techniques of EUS-guided tumour ablation have been described, including RF ablation, photodynamic therapy, laser ablation, and ethanol injection (4). Kahaleh et al. have demonstrated that Endoscopic ultrasound guided RF ablation (EUS-RFA) of the pancreatic head using Habib EUS-RFA catheter (EMcision Ltd, UK) through a 19-gauge needle was well tolerated in 5 Yucatan pigs and with minimum amount of pancreatitis (5). In a pilot clinical study, Pai et al showed either a complete response or at least a 50% reduction in tumours following application of radiofrequency ablation with the Habib™ EUS-RFA device in a group of eight patients with pancreatic cancers (3).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Survival
timeFrame: 1 month
measure: Survival
timeFrame: at time of death on average 10months
Secondary outcomes:
measure: Quality of life (HEALTH, SOCIAL INTERACTIONS, DAILY ACTIVITIES)
timeFrame: 1 month
measure: Quality of life (HEALTH, SOCIAL INTERACTIONS, DAILY ACTIVITIES)
timeFrame: Time of death on average 10 months
measure: Pain reduction
timeFrame: 1 month
measure: Pain reduction
timeFrame: Time of death on average 10months
measure: Tumour Size
timeFrame: 4 months
measure: Monitoring of Adverse reactions
timeFrame: At time of death on average 10months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre de recherche du Centre hospitalier de l'université de Montréal
state: Quebec
Study officials:
affiliation: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
name: ANAND V SAHAI, MD
role: PRINCIPAL_INVESTIGATOR
References: