Clinical trial for Pancreatic Adenocarcinoma Metastatic
Official title TTFields and Chemotherapy in Metastatic Pancreatic Adenocarcinoma (mPDAC)
ClinicalTrials.gov ID: NCT07284277
What this study is testing
What is TTFields concomitant with modFOLFIRINOX?
This is an investigational combination of a portable electric field device and chemotherapy being studied for metastatic pancreatic adenocarcinoma. The device is designed to deliver electric fields that disrupt cancer cell division.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if the device is safe and well tolerated when used with a chemotherapy regimen called modFOLFIRINOX. It also looks at whether patients can keep using the device and if it helps fight the cancer.
- Who it's for
- Adults who have pancreatic cancer that has spread to other parts of the body and who can receive the modFOLFIRINOX chemotherapy.
- What's involved
- Participants will wear a small device that delivers electric fields to the body while receiving chemotherapy. They will have regular clinic visits for treatment, monitoring, and tests to check safety and effectiveness.
- Time commitment
- The study lasts several months, with multiple clinic visits and daily use of the device at home. Participants must attend scheduled appointments and wear the device as directed.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
- Known dihydropyrimidine dehydrogenase deficiency or thymidylate synthase gene polymorphism predisposing the patient for 5-fluorouracil (5-FU)...
- 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.
See the full eligibility 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.
- Amenable and assigned by the investigator to receive therapy with modFOLFIRINOX.
- 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.
- Able to operate the Novo TTF-200T System independently or with the help of a caregiver.
- Adequate hematologic and organ function, defined by the following laboratory test results, obtained during the screening period and before C1D1.
- WBC higher than or equal to 2.5 x 10\^9/L.
- ANC higher than or equal to 1.5 x 10\^9/L without granulocyte colony-stimulating factor support.
- Platelet count higher than or equal to 100 x 10\^9/L without transfusion.
- Hemoglobin higher than or equal to 9 g/dL. Patients may be transfused to meet this criterion.
- Albumin higher than or equal to 2.5 g/dL.
- Serum bilirubin lower than or equal to 1.5 times the upper limit of normal (ULN); patients with known Gilbert´s disease may have a bilirubin value lower than or equal to 3 x ULN.
- INR and aPTT lower than or equal to 1.5 x ULN.
- AST, ALT, lower than or equal to 5 x ULN.
- Serum creatinine lower than or equal to 1.5 x ULN or Creatinine Clearance higher than or equal to 30ml/min (calculated using Cockcroft-Gault formula).
- 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...
- 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...
- 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.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- Pregnant and lactating women
- Patients who have received brivudine, sorivudine or analogues 4 weeks prior to Fluoracile administration.
- History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree hart block; significant ischemic heart disease
- History of cerebrovascular accident (CVA) within 3 months prior to randomization or that is not stable.
- Active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol therapy.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Pamplona, Navarre, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Pamplona, Navarre, Spain. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.