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
Overview
- Phase
- Phase 2
- Intervention
- Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA)
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Number of participants who are able to complete neoadjuvant chemotherapy plus EUS-RFA and later undergo surgical tumor resection
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief 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.
Investigators
Nirav C Thosani
Associate Professor
The University of Texas Health Science Center, Houston
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Male or female patients \< 18 years of age
- •No permanent street address or telephone number
- •Pregnant patients
- •Inmates or prisoners
- •Unable to provide informed consent
Arms & Interventions
Neoadjuvant chemotherapy (NAC) plus endoscopic ultrasound (EUS) radiofrequency ablation (RFA)
Intervention: Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA)
Neoadjuvant chemotherapy (NAC) plus endoscopic ultrasound (EUS) radiofrequency ablation (RFA)
Intervention: Neoadjuvant Chemotherapy (NAC)
Outcomes
Primary Outcomes
Number of participants who are able to complete neoadjuvant chemotherapy plus EUS-RFA and later undergo surgical tumor resection
Time Frame: From the time of EUS-RFA NAC intervention to the time of surgical tumor resection (about 5-6 months)
Secondary Outcomes
- Disease-free survival time(from the time of diagnosis to time of recurrence (or up to 5 years after diagnosis, whichever occurs first))
- Number of participants with post-operative complications(from the time of surgical tumor resection to 90 days following surgical tumor resection)
- Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria(4 months after the initiation of chemotherapy)