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RECRUITING
NCT07284277
PHASE1/PHASE2

TTFields and Chemotherapy in Metastatic Pancreatic Adenocarcinoma (mPDAC)

Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

View on ClinicalTrials.gov

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?

Official title: Phase Ib-II, Non-randomized, Open-label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With modFOLFIRINOX for Front-line Treatment of Metastatic Pancreatic Adenocarcinoma (NOVOFFOX)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-10-14

Completion Date

2027-03

Last Updated

2025-12-16

Healthy Volunteers

No

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.

Locations (5)

Clínica Universidad de Navarra

Pamplona, Navarre, Spain

Hospital Universitario de Cruces

Barakaldo, Vizcaya, Spain

Hospital de Galdakao

Galdakao, Vizcaya, Spain

Fundación Jiménez-Díaz

Madrid, Spain

Hospital Universitario de Araba

Vitoria-Gasteiz, Álava, Spain