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EUS-RFA PANCARDINAL-1 Trial

StatusRecruiting
PhasePhase 2
Started2021-08-13
View on ClinicalTrials.gov ↗

Amendment history

2026-07-27
Study Status, Contacts/Locations v8
Study sitescontacts updated at 1 of 1 site
2025-05-15
Study Status v7
Primary completion date2025-05-01→2026-12-01
2024-06-20
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v6
Primary completion date2024-07-31→2025-05-01
Completion date2028-01-30→2028-05-30
Enrollment target15→60
InterventionsEndoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA) (Device), Neoadjuvant chemotherapy (NAC) (Drug)→Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA) (Device), Neoadjuvant Chemotherapy (NAC) (Drug)
Eligibility criteria-75 characters
Inclusion Criteria: Diagnosed and histologically-confirmed PDAC by biopsy Permanent street address and consent Consent to study participation Axial CT scan consistent with PDAC N [...] or less than 2 months of pre-operative chemotherapy for PDAC. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Exclusion Criteria: No phone number of Male or Femalefemale patients >< 18 years of age Diagnosed and histologically confirmed PDAC by biopsy No permanent street address or telephone number Pregnant pat [...]
Study sitescontacts updated at 1 of 1 site
Collaborators+31 characters
National Cancer Institute (NCI)
Study title-172 characters
AEUS-RFA SinglePANCARDINAL-arm1 Phase II Study to Evaluate the Safety and Efficacy of Combination Systematic Chemotherapy and Multiple Rounds of Endoscopic Ultrasound-guided Radiofrequency Ablation in Pancreatic CancerTrial
2023-04-19
Study Identification, Study Status, Contacts/Locations v5
Start date2021-07-23→2021-08-13
Study sitescontacts updated at 1 of 1 site
Study title+136 characters
A Single-arm Phase II Study to Evaluate the Safety and Efficacy of Combination Systematic Chemotherapy and Multiple Rounds of Endoscopic Ultrasound-guided PANcreaticRadiofrequency CAncerAblation RaDIofrequeNcyin AbLationPancreatic Cancer
2023-02-15
Study Status v4
Re-verified, no change to tracked fields
Show 3 earlier versions
2021-09-20
Study Identification, Study Status, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v3
PhaseNot applicable→Phase 2
InterventionsEndoscopic Ultrasound (EUS) Radiofrequency Ablation (RFA) (Procedure)→Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA) (Device), Neoadjuvant chemotherapy (NAC) (Drug)
Eligibility criteria-5 characters
Inclusion Criteria: Male or Female patients > 18 years of age Diagnosed and histologically confirmed PDAC by biopsy Perman [...] less than 2 months of pre-operative chemotherapy for PDAC. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Exclusion Criteria: No phone number [...]
Secondary endpoints+321 characters
Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria Number of participants with post-operative complications Disea [...]
Primary endpoints1 entry, revised
The proportionNumber of resectableparticipants PDACwho patientsare thatable to complete neoadjuvant chemotherapy +plus EUS-RFA and later undergo surgical tumor resection.
Study sitescontacts updated at 1 of 1 site
Study title-12 characters
Endoscopic Ultrasound Guided-PANcreatic RadiofrequencyCAncer AblationRaDIofrequeNcy Pancreas Cancer TrialAbLation
2021-09-08
Study Status, Document Section v2
Re-verified, no change to tracked fields
2021-08-06
Study Identification, Study Status, Outcome Measures, Document Section v1
Primary endpoints1 entry, revised
ToThe determine the feasibility and tolerabilityproportion of NACresectable PDAC patients that complete neoadjuvant chemotherapy + EUS RFA inand theundergo treatmentsurgical of PDACresection.
Study title+18 characters
EUSEndoscopic Ultrasound Guided- PancreaticRadiofrequency Ablation Pancreas Cancer RFA: Phase II PANCARDINAL-1 Trial
2021-07-26
Original filing
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.
Trial Details
NCT Number NCT04990609
Lead Sponsor The University of Texas Health Science Center, Houston
Collaborators: National Cancer Institute (NCI)
Conditions Pancreatic Ductal Adenocarcinoma (PDAC)
Enrollment 60 participants
Start Date 2021-08-13
Primary Completion 2026-12-01 (estimated)
Study Completion 2028-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-29