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 range18 Years
SexALL
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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.
✓. 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).
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
✕. 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.