Pancreatic Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with locally advanced pancreatic adenocarcinoma, confirmed by a tissue or cell sample analysis
• People whose tumor is in a location where the Alpha DaRT radiation seeds can be physically inserted
• People whose tumor can be measured using standard imaging criteria (called RECIST 1.1)
• People whose cancer has stayed stable or shrunk since starting the chemotherapy regimen called mFOLFIRINOX
• People whose tumor is no larger than 5 cm at its widest point
• People whose case has been reviewed and approved for this type of internal radiation treatment by a full specialist team, including an oncologist, radiation oncologist, radiologist, gastroenterologist, and a surgeon with expertise in pancreatic cancer
• People who have completed 8 to 12 cycles of mFOLFIRINOX chemotherapy
• People who are in good general health, rated 0 or 1 on the ECOG scale (meaning fully active or able to carry out light work) (confirm with trial site)
• People whose life expectancy is estimated to be more than 6 months
• People whose blood test results meet the required levels for white blood cells, granulocytes, and platelets
• People whose kidney function test (creatinine) result is within the required range
• People whose liver enzyme levels (AST and ALT) are within an acceptable range
• People whose blood clotting measure (INR) is below 1.4, if not taking the blood thinner Warfarin
• People aged 18 years or older
• People who are willing and able to sign a consent form agreeing to take part
• Women who could become pregnant must have a negative pregnancy test before the procedure and must use an accepted form of contraception for at least 3 months after treatment begins
• All participants must agree to use adequate contraception (such as vasectomy or a barrier method) before joining, throughout the study, and for 3 months after the device is inserted

Who may not be able to join:

• People who have received immunotherapy within the past 4 weeks
• People whose cancer has spread to other parts of the body (metastatic disease)
• People whose cancer is considered borderline removable by surgery, or who are suitable for surgical exploration, unless the person has declined surgery
• People with a known allergy or sensitivity to any component of the treatment
• People currently taking long-term medications that suppress the immune system (short or occasional use of corticosteroids may be acceptable — confirm with trial site)
• People with serious heart conditions, such as severe heart failure, uncontrolled coronary artery disease, uncontrolled irregular heartbeat, uncontrolled high blood pressure, or a heart attack within the past 12 months
• People with other serious uncontrolled health conditions, including active infections requiring treatment, or mental health or substance use conditions that could interfere with taking part in the trial
• People who have another cancer that is currently growing or requiring active treatment (some exceptions apply, such as certain skin cancers, low-risk prostate cancer, or cervical cancer in its earliest stage — confirm with trial site)
• People who require treatments not covered by this trial's protocol that could interfere with measuring the effects of the DaRT treatment
• People who do not agree to use adequate contraception before, during, and for 3 months after the study
• People who have participated in another interventional clinical trial within the past 30 days, where that trial could interfere with this study's results
• People who, in the opinion of the research team, are unlikely to follow the study requirements
• Women who are breastfeeding, or women who could become pregnant and are unwilling or unable to use an acceptable form of contraception for 3 months after treatment

Important: Always verify eligibility with the trial site directly before applying.