EUS-RFA PANCARDINAL-1 Trial

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT04990609
Phase
PHASE2
Status
Recruiting
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Conditions

  • Pancreatic Ductal Adenocarcinoma (PDAC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA) — DEVICE
    Endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA) consists of the application of an alternating current with a frequency of 350-500 kilohertz (kHz) to the target tissue via a special electrode located at the tip of an echoendoscope. The alternating current causes the vibratory movement of ionic particles in the abutting and adjoining tissue and results in the generation of heat. However, RFA induces not only local disruption of the tumor by heat, but it also produces localized coagulation necrosis of the tumor; which induces the release of large amounts of cellular debris. This cellular debris represents a source of tumor antigens that can trigger a host adaptive immune response against the tumor.
  • Neoadjuvant Chemotherapy (NAC) — DRUG
    The NAC regimen will be determined clinically by the participant's physician \[possible regimens are either mFOLFIRINOX or Gemcitabine Nab-Paclitaxel +/- Cisplatin (GemAbraxane)\].

Study Details

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.

Key Dates

Start date
Aug 13, 2021
Status verified
May 2025
Primary completion
Dec 1, 2026
Completion
May 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant chemotherapy (NAC) plus endoscopic ultrasound (EUS) radiofrequency ablation (RFA)

Primary Outcome Measure

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Hermann HospitalHoustonTexas77030
Nirav Thosani, MD
[email protected]
713-486-1350
Sofia C Colon, BS
[email protected]
713-500-6658
Nirav Thosani, MD, MHA (PRINCIPAL_INVESTIGATOR)
Curtis Wray, MD (SUB_INVESTIGATOR)
Jennifer Bailey, PhD, MA (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By research site
Memorial Hermann Hospital· Houston, TX

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