EUS-RFA for Inoperable Pancreatic Ductal Adenocarcinoma.

• Status: Withdrawn
• Trial end date: 0000-00-00
• Target enrollment: 0
• Participant gender: All

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 .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: A Sahai
• Last Updated: 2017-08-02

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 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