Actively Recruiting
TTFields and Chemotherapy in Metastatic Pancreatic Adenocarcinoma (mPDAC)
Led by Clinica Universidad de Navarra, Universidad de Navarra · Updated on 2025-12-16
30
Participants Needed
5
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
TTFields and Chemotherapy in Metastatic Pancreatic Adenocarcinoma (mPDAC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or cytological diagnosis of pancreatic adenocarcinoma
- Age 18 years or older
- Provided consent to participate in the study
- Able to comply with all clinical trial requirements
- Life expectancy of at least 3 months
- Metastatic disease with at least one liver lesion accessible for biopsy
- Measurable disease by RECIST 1.1 criteria apart from the liver lesion to be biopsied
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Assigned and able to receive modFOLFIRINOX therapy
- Prior chemotherapy or radiotherapy allowed if completed at least 6 months before study entry
- Able to operate the Novo TTF-200T System independently or with caregiver assistance
- Adequate hematologic and organ function based on specific laboratory test results
- For women of childbearing potential: negative pregnancy test within 14 days prior to treatment and agreement to use effective contraception during treatment and for 180 days after
You will not qualify if you...
- Other malignancies within 3 years prior to study start, except those with very low risk of metastasis or death
- Previous chemotherapy for metastatic pancreatic ductal adenocarcinoma
- Untreated central nervous system metastases
- Known deficiency or gene polymorphism increasing 5-fluorouracil toxicity
- Radiation therapy within 14 days prior to treatment or ongoing radiation side effects
- Implantable electronic devices in the torso (e.g., pacemakers)
- Severe allergies or hypersensitivity to study treatments or adhesives
- Untreated spinal cord compression
- Uncontrolled pleural, pericardial effusions, or ascites needing frequent drainage
- Pregnant or breastfeeding women
- Use of certain antiviral drugs within 4 weeks prior to chemotherapy
- Serious co-morbidities including uncontrolled cardiovascular disease, recent stroke, active infections, or psychiatric conditions impairing study compliance
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Clínica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
2
Hospital Universitario de Cruces
Barakaldo, Vizcaya, Spain, 48903
Not Yet Recruiting
3
Hospital de Galdakao
Galdakao, Vizcaya, Spain, 48960
Not Yet Recruiting
4
Fundación Jiménez-Díaz
Madrid, Spain, 28040
Not Yet Recruiting
5
Hospital Universitario de Araba
Vitoria-Gasteiz, Álava, Spain, 01009
Not Yet Recruiting
Research Team
M
Mariano Ponz Sarvisé, MD, PhD
CONTACT
L
Lucía Ceniceros
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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