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Concurrent FOLFIRINOX Plus High Intensity Focused Ultrasound for Pancreatic Cancer

NCT05262452 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-10-26

No results posted yet for this study

Summary

In patients diagnosed with locally advanced pancreatic cancer (LAPC)/borderline resectable pancreatic cancer (BRPC) and planned chemotherapy using FOLFIRINOX, high intensity focused ultrasound (HIFU)/FOLFIRINOX combined treatment is performed on patients who agree to this study. The combined treatment group is treated in parallel with FOLFIRINOX and HIFU for the first four cycles and then CT is taken for reaction evaluation immediately, 2 months, and 4 months after the four-cycle treatment. For the response assessment, the response rate using RECIST ver. 1.1 and operable rate are evaluated and compared with the results of already established FOLFIRINOX single treatment in the investigators' institute. Time-to-progress and overall survival are calculated.

Conditions

  • Pancreatic Cancer Non-resectable
  • Chemotherapy Effect
  • Ultrasound Therapy

Interventions

DEVICE

ALPIUS 900, an ultrasound-guided high intensity focused ultrasound system

Device to deliver mechanical stress and force to enhance drug delivery, using focused ultrasound

DRUG

FOLFIRINOX regimen

a chemotherapy regimen for treatment of advanced pancreatic cancer * FOL : folinic acid (leucovorin), a vitamin B derivative that enhances the effects of 5-FU * F : 5-FU, a pyrimidine analog and antimetabolite which incorporates into the DNA molecule and stops DNA synthesis * IRIN : irinotecan (eloxatin), a platinum-based antineoplastic agent, which inhibits DNA repair and/or DNA synthesis. * OX - oxaliplatin (Eloxatin), a platinum-based antineoplastic agent, which inhibits DNA repair and/or DNA synthesis

Sponsors & Collaborators

  • Focused Ultrasound Foundation

    collaborator OTHER

  • Synex Consulting Ltd

    collaborator UNKNOWN

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Jae Young Lee, MD · Seoul National University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-09
Primary Completion
2023-03-31
Completion
2024-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05262452 on ClinicalTrials.gov