A Single-arm Phase II Study to Evaluate the Safety and Efficacy of Combination Systematic Chemotherapy and Multiple Rounds of Endoscopic Ultrasound-guided Radiofrequency Ablation in Pancreatic Cancer

Who is this study for? Patients with Pancreatic Ductal Adenocarcinoma
What treatments are being studied? Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA)+Neoadjuvant Chemotherapy (NAC)
Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The objectives of this study are to determine the feasibility, tolerability, and treatment effect of endoscopic ultrasound (EUS) radiofrequency ablation (RFA) plus standard-of-care neoadjuvant chemotherapy (NAC) in the treatment of pancreatic ductal adenocarcinoma (PDAC). Endoscopic ultrasound (EUS) radiofrequency ablation (RFA) and neoadjuvant chemotherapy (NAC) will be performed before tumor resection surgery, with the goal of shrinking a tumor or stopping the spread of cancer so that surgery might be less invasive and more effective.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosed and histologically-confirmed PDAC by biopsy

• Permanent street address

• Consent to study participation

• Axial CT scan consistent with PDAC

• No prior chemotherapy or less than 2 months of pre-operative chemotherapy for PDAC

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Locations
United States
Texas
Memorial Hermann Hospital
RECRUITING
Houston
Contact Information
Primary
Sofia C Colon, BS
Sofia.C.Colon@uth.tmc.edu
713-500-6658
Backup
Nirav Thosani, MD
pancreasresearch@uth.tmc.edu
713-486-1350
Time Frame
Start Date: 2021-08-13
Estimated Completion Date: 2028-05-30
Participants
Target number of participants: 60
Treatments
Experimental: Neoadjuvant chemotherapy (NAC) plus endoscopic ultrasound (EUS) radiofrequency ablation (RFA)
Related Therapeutic Areas
Sponsors
Leads: The University of Texas Health Science Center, Houston
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov