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2021-08-13
2026-12-01
2028-05-30
60
NCT04990609
The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
INTERVENTIONAL
EUS-RFA PANCARDINAL-1 Trial
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-02-02 | N/A | 2025-05-15 |
2021-07-26 | N/A | 2025-05-21 |
2021-08-04 | N/A | 2025-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Neoadjuvant chemotherapy (NAC) plus endoscopic ultrasound (EUS) radiofrequency ablation (RFA) | DEVICE: Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA)
DRUG: Neoadjuvant Chemotherapy (NAC)
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria | Using the RECIST criteria, treatment response is categorized as follows: * Complete response (CR): Disappearance of all target lesions * Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD * Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started * Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions | 2 months after the initiation of chemotherapy |
| Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria | Using the RECIST criteria, treatment response is categorized as follows: * Complete response (CR): Disappearance of all target lesions * Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD * Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started * Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions | 4 months after the initiation of chemotherapy |
| Number of participants with post-operative complications | from the time of surgical tumor resection to 90 days following surgical tumor resection | |
| Disease-free survival time | Disease is defined as clinical evidence of local or distant recurrence. | from the time of diagnosis to time of recurrence (or up to 5 years after diagnosis, whichever occurs first) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Sofia C Colon, BS Phone Number: 713-500-6658 Email: Sofia.C.Colon@uth.tmc.edu |
Study Contact Backup Name: Nirav Thosani, MD Phone Number: 713-486-1350 Email: pancreasresearch@uth.tmc.edu |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
