Menu
Recruiting NCT04990609

EUS-RFA PANCARDINAL-1 Trial

Phase II Interventional Pancreatic Ductal Adenocarcinoma (PDAC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA), Neoadjuvant Chemotherapy (NAC).
Who it may be relevant to
Registry conditions: Pancreatic Ductal Adenocarcinoma (PDAC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Device Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA)
    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 coa
  • Drug Neoadjuvant Chemotherapy (NAC)
    The NAC regimen will be determined clinically by the participant's physician \[possible regimens are either mFOLFIRINOX or Gemcitabine Nab-Paclitaxel +/- Cisplatin (GemAbraxane)\].

Primary outcome measures

  • 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 outcome measures (4)
  • Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria [Time frame: 2 months after the initiation of chemotherapy]
  • Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria [Time frame: 4 months after the initiation of chemotherapy]
  • Number of participants with post-operative complications [Time frame: from the time of surgical tumor resection to 90 days following surgical tumor resection]
  • Disease-free survival time [Time frame: from the time of diagnosis to time of recurrence (or up to 5 years after diagnosis, whichever occurs first)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Memorial Hermann Hospital — Houston

Identifiers

NCT: NCT04990609 · HSC-MS-21-0066 · R01CA277161-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗