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TTFields and Chemotherapy in Metastatic Pancreatic Adenocarcinoma (mPDAC)

NCT07284277 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-16

No results posted yet for this study

Summary

The purpose of this clinical trial is to assess the safety and tolerability of TTFields in combination with chemotherapy in adults with metastatic pancreatic adenocarcinoma based on treatment-emergent adverse events of chemotherapy (modFOLFIRINOX) or device (TTFields).

The main questions it aims to answer are:

* Is TTFields treatment safe for the patients in combination with modFOLFIRINOX?
* Are participants compliant with the treatment?
* Is Is TTFields treatment effective in combination with modFOLFIRINOX against metastatic pancreatic adenocarcinoma?

Conditions

Interventions

COMBINATION_PRODUCT

TTFields concomitant with modFOLFIRINOX

Patients will receive the following medication in 14-day cycles: ModFOLFIRINOX * Folic acid (Leucovorin) 400mg/m2 (D,L, racemic form) or 200mg/m2 (L-isomer form) * 5-fluorouracil (5Fu) 2400 mg/m2 * Oxaliplatin 85mg/m2 * Irinotecan 150-180mg/m2 Combined with TTFields, which is a portable battery operated system intended for continuous home use (at least 18h/day) which delivers TTFields at a frequency of 150kHz to produces electric forces intended to disrupt cancer cell division.

Sponsors & Collaborators

  • Clinica Universidad de Navarra, Universidad de Navarra

    lead OTHER

Principal Investigators

  • Mariano Ponz Sarvisé, MD, PhD · Clínica Universidad de Navarra

  • Patricia Seoane Couselo, MD · Hospital Universitario de Araba

  • Fernando Garicano Goldáraz, MD · Hospital de Galdakao

  • Alberto Muñoz Llarena, MD · Hospital Universitario de Cruces

  • Ángela Lamarca Lete, MD, PhD · Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-14
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT07284277 on ClinicalTrials.gov