EUS-RFA for Inoperable Pancreatic Ductal Adenocarcinoma.

Adenocarcinoma of the Pancreas Clinical Trial

Official title:

A Phase II Prospective Randomised Clinical Study of Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Inoperable Pancreatic Ductal Adenocarcinoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03065985
• Other study ID #: 16.307
• Status: Withdrawn
• Phase: Phase 2
• First received: February 17, 2017
• Last updated: August 2, 2017
• Start date: August 2017
• Est. completion date: March 2019

Study information

• Verified date: August 2017
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess if endoscopic ultrasound radiofrequency application in patients with inoperable pancreatic cancer and chemotherapy confers survival benefit when compared to patients receiving best medical care and chemotherapy .

Description:

Prospective randomised clinical study in patients with adenocarcinoma of the pancreas.

Patients will be randomised 1:1. Patients in the treatment group will receive standard chemotherapy plus 3 radiofrequency ablation procedures, each one month apart.

Patients in the control group will receive standard chemotherapy and best medical care.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 who have been deemed unfit for surgical resection of the PDAC; subjects who are fit for surgical resection, but have declined surgery will also be considered for the study

• PDAC patients presenting with jaundice to be considered after a successful biliary drainage (bilirubin <50umol/L)

• Patients ought to be fit enough to be considered for the study (ECOG 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

• Prior investigational drugs within the last 30 days

• Grade > 1 treatment-related toxicities (excluding alopaecia) at the time of screening

• Patients with clinically significant cancer ascites

• Known infection with human immunodeficiency virus (HIV)

• Patient with central nervous system (CNS) metastasis

• Major surgery within the last 30 days

• Patients with sepsis, obstructive jaundice or encephalopathy

• Evidence of spontaneous bacterial peritonitis or renal failure

• Pregnant or lactating women

• Any other condition (e.g., known or suspected poor compliance, etc.) that, in the judgment of the investigator, may affect the participant's ability to follow the protocol specific procedure

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Pancreas

Intervention

Device:
• 3 radiofrequency ablation procedures (Habib™ EUS-RFA)
Patients in the treatment group will receive standard chemotherapy plus 3 radiofrequency ablation procedures, each one month apart. Investigators will use the Habib™ EUS-RFA, product number 6700, which is a 1 Fr wire (0.33 mm, 0.013") with a working length of 200 cm, which can be inserted through the biopsy channel of an echoendoscope and is compatible with a 19G or 22G echoendoscopic needle. RF power is applied to the electrode at the end of the wire to coagulate tissue in the pancreas at 10 Watts for 2 minutes for each application. It has a CE mark and FDA 510(k) approval.

Drug:
• Standard chemotherapy
Standard chemotherapy

Other:
• Best Medical Care
Best Medical Care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
A Sahai

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease in primary tumour measurement		up to one year
Primary	decrease in metastatic spread		up to one year
Primary	decrease in pain control needs		up to one year
Secondary	Stage migration to other conventional therapy		up to one year