TTFields and Chemotherapy in Metastatic Pancreatic Adenocarcinoma (mPDAC) (NCT07284277) | Clinical Trial Compass
RecruitingPhase 1/2
TTFields and Chemotherapy in Metastatic Pancreatic Adenocarcinoma (mPDAC)
Spain30 participantsStarted 2025-10-14
Plain-language 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?
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histological/cytological diagnosis of pancreatic adenocarcinoma.
. The patient should be 18 years of age and older.
. The patient has given consent to participate in the study.
. The patient should be able to comply with all the requirements of the clinical trial.
. Life expectancy of at least 3 months.
. Metastatic disease with, at least, one hepatic lesion that must be accessible for biopsy.
. Measurable disease as defined by Response Evaluation Criteria in Solid Tumor v1.1 (RECIST 1.1) apart from the liver lesion to be biopsied.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Toxicity profile in patients with mPDAC treated at 1L with TTFields concomitantly with modFOLFIRINOX
Timeframe: From the beginning of the first treatment cycle (cycle 1; each treatment cycle is 14 days) through study completion (for a maximum of 24 months per patient since inclusion)
Trial details
NCT IDNCT07284277
SponsorClinica Universidad de Navarra, Universidad de Navarra
. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Exclusion criteria
. Malignancies other than pancreatic cancer within 3 years prior to Cycle 1 Day 1 (C1D1) with the exceptions of those with a negligible risk of metastasis or death (e.g., expected 5-year overall survival higher than 90 percentage), treated with expected curative outcome (such as but not limited to: adequately treated in situ carcinoma of the cervix, basal squamous or melanomatous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ of the breast treated surgically with curative intent).
. Previous treatment with chemotherapy for metastatic pancreatic ductal adenocarcinoma.
. Untreated CNS metastases. Treatment of brain metastases, either by surgical or radiation techniques, must have been completed at least 4 weeks prior to study entry.
. Known dihydropyrimidine dehydrogenase deficiency or thymidylate synthase gene polymorphism predisposing the patient for 5-fluorouracil (5-FU) toxicity.
. Previous radiation therapy within 14 days prior to C1D1 and/or persistence of radiation-related adverse effects.
. Implantable electronic medical devices in the torso, such as pacemakers.
. Known severe hypersensitivities to medical adhesives or hydrogel, or history of severe allergic, anaphylactic, or other hypersensitivity reactions to any of the study treatments used.
. Spinal cord compression not definitively treated with surgery and/or radiation.