CALCIUM FOLINATE for Metastatic pancreatic adenocarcinoma

Inclusion criteria

• {"criterion_text":"- Histological/cytological diagnosis of pancreatic adenocarcinoma.\n- Prior chemotherapy or radiotherapy on the neoadjuvant or adjuvant setting is allowed as long as at least six months have elapsed since last chemotherapy treatment.\n- Able to operate the Novo TTF-200T System independently or with the help of a caregiver.\n- Adequate hematologic and organ function, defined by the following laboratory test results, obtained during the screening period and before C1D1. a. WBC > 2.5 x 109/L. b. ANC > 1.5 x 109/L without granulocyte colony-stimulating factor support. c. Platelet count > 100 x 109/L. without transfusion. d. Hemoglobin > 9 g/dL. e. Albumin > 2.5 g/dL. f. Serum bilirubin < 1.5 times de upper limit of normal (ULN); patients with known Gilbert´s disease may have a bilirubin value < 3 x ULN. g. INR and aPTT < 1.5 x ULN. h. AST, ALT, < 5 x ULN. i. Serum creatinine < 1,5 x ULN or Creatinine Clearance > 30ml/min (calculated using Cockcroft-Gault formula).\n- For women of childbearing potential: Negative serum pregnancy test within 14 days prior to C1D1. Agreement to remain abstinent (refrain from heterosexual intercourse) or use of contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 180 days after the last study treatment. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (> 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).\n- The patient should be 18 years of age and older.\n- The patient has given consent to participate in the study.\n- The patient should be able to comply with all the requirements of the clinical trial.\n- Life expectancy of > 3 months.\n- Metastatic disease with, at least, one hepatic lesion that must be accessible for biopsy.\n- Measurable disease as defined by Response Evaluation Criteria in Solid Tumor v1.1 (RECIST 1.1) apart from the liver lesion to be biopsied.\n- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n- Amenable and assigned by the investigator to receive therapy with modFOLFIRINOX."}

Exclusion criteria

• {"criterion_text":"- 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 >90%), 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).\n- Pregnant and lactating women.\n- Patients who have received brivudine, sorivudine or analogues 4 weeks prior to Fluoracile administration.\n- Serious co-morbidities, including but not limited to: a. History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree hart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse. b. History of cerebrovascular accident (CVA) within 3 months prior to randomization or that is not stable. c. Active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol therapy. d. History of any psychiatric condition that might impair patient´s ability to understand or comply with the requirements of the study or to provide consent.\n- Previous treatment with chemotherapy for metastatic pancreatic ductal adenocarcinoma.\n- 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.\n- Known dihydropyrimidine dehydrogenase deficiency or thymidylate synthase gene polymorphism predisposing the patient for 5-fluorouracil (5-FU) toxicity.\n- Previous radiation therapy within 14 days prior to C1D1 and/or persistence of radiation-related adverse effects.\n- Implantable electronic medical devices in the torso, such as pacemakers.\n- 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.\n- Spinal cord compression not definitively treated with surgery and/or radiation.\n- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures."}

Primary endpoints

• {"endpoint_text":"- Toxicity profile in patients with mPDAC treated at 1L with TTFields concomitantly with modFOLFIRINOX, measured by the rate of patients with treatment-emergent adverse events (TEAEs), using CTCAE v5.0.","definition_or_measurement_approach":"Measured by the rate of patients with treatment-emergent adverse events (TEAEs), using CTCAE v5.0."}

Secondary endpoints

• {"endpoint_text":"- Total hours with TTField device functioning during every 14 days chemotherapy cycle","definition_or_measurement_approach":""}
• {"endpoint_text":"- QoL assessed using EORTC QLQ-30 questioner","definition_or_measurement_approach":"Quality of Life assessed using the EORTC QLQ-30 questionnaire."}
• {"endpoint_text":"- Progression-free survival (PFS): defined as the time from first modFOLFIRINOX administration until disease progression based on CT scan collected on the study according to RECIST 1.1 criteria or any cause related death, whichever occurs first","definition_or_measurement_approach":"Time from first modFOLFIRINOX administration until disease progression by CT scan per RECIST 1.1 or death from any cause."}
• {"endpoint_text":"- Overall survival (OS): defined as the time from first modFOLFIRINOX administration until patient death","definition_or_measurement_approach":"Time from first modFOLFIRINOX administration until death."}
• {"endpoint_text":"- Overall response rate (ORR): defined as the percentage of patients with complete response (CR) or partial response (PR) as best overall response (BOR) according to RECIST 1.1","definition_or_measurement_approach":"Percentage of patients with CR or PR as best overall response according to RECIST 1.1."}
• {"endpoint_text":"- Disease control rate (DCR): defined as the percentage of patients with CR or PR and the percentage of subjects with stable (SD) of at least 12 weeks duration as BOR according to RECIST 1.1","definition_or_measurement_approach":"Percentage of patients with CR or PR and percentage with stable disease (SD) of at least 12 weeks as BOR per RECIST 1.1."}

Spain

Earliest CTIS Part Ii Submission Date

04-02-2025

Latest Decision Or Authorization Date

09-02-2026

Processing Time Days

370

Number Of Sites

7

Number Of Participants

30

Primary sponsor

Full Name

Clinica Universidad De Navarra

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain

Contract research organisations

Name

Sermes CRO

Responsibilities

Regulatory expertise, on site monitoring, Statistical analysis, Project management, Safety reporting, Data management

Third parties

• {"country":"Spain","full_name":"Sermes CRO","duties_or_roles":"Regulatory expertise, on site monitoring, Statistical analysis, Project management, Safety reporting, Data management","organisation_type":"Pharmaceutical company"}