RecruitingRecruiting
EUS-RFA PANCARDINAL-1 Trial
NCT04990609 · The University of Texas Health Science Center, Houston
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
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 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
Study design
Enrollment target: 60 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-08-13
Estimated completion: 2028-05-30
Last updated: 2025-05-21
Interventions
Device: Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA)Drug: Neoadjuvant Chemotherapy (NAC)
Primary outcomes
- • Number of participants who are able to complete neoadjuvant chemotherapy plus EUS-RFA and later undergo surgical tumor resection (From the time of EUS-RFA NAC intervention to the time of surgical tumor resection (about 5-6 months))
Sponsor
The University of Texas Health Science Center, Houston · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactSofia C Colon, BS · contact · Sofia.C.Colon@uth.tmc.edu · 713-500-6658
ContactNirav Thosani, MD · contact · pancreasresearch@uth.tmc.edu · 713-486-1350
InvestigatorNirav Thosani, MD · principal_investigator, The University of Texas Health Science Center, Houston
All locations (1)
Memorial Hermann HospitalRecruiting
Houston, Texas, United States