RECRUITING

EUS-RFA PANCARDINAL-1 Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-08-13
Study Completion:2028-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04990609

Participation Criteria

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed and histologically-confirmed PDAC by biopsy
  2. * Permanent street address
  3. * Consent to study participation
  4. * Axial CT scan consistent with PDAC
  5. * No prior chemotherapy or less than 2 months of pre-operative chemotherapy for PDAC
  6. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  1. * Male or female patients \< 18 years of age
  2. * No permanent street address or telephone number
  3. * Pregnant patients
  4. * Inmates or prisoners
  5. * Unable to provide informed consent

Contacts and Locations

Study Contact

Sofia C Colon, BS
CONTACT
713-500-6658
Sofia.C.Colon@uth.tmc.edu
Nirav Thosani, MD
CONTACT
713-486-1350
pancreasresearch@uth.tmc.edu

Principal Investigator

Nirav Thosani, MD
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston

Study Locations (Sites)

Memorial Hermann Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

  • Nirav Thosani, MD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

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

Study Start Date2021-08-13
Study Completion Date2028-05-30

Study Record Updates

Study Start Date2021-08-13
Study Completion Date2028-05-30

Terms related to this study

Keywords Provided by Researchers

  • Endoscopic Ultrasound Radiofrequency ablation (EUS-RFA)

Additional Relevant MeSH Terms

  • Pancreatic Ductal Adenocarcinoma (PDAC)