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New treatment option for Pancreatic Cancer
Official title Alpha Radiation Emitters (DaRT) With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer
ClinicalTrials.gov ID: NCT06698458
What this study is testing
- What it's testing
- This is a multi-center clinical study enrolling up to 30 participants (15 patients in each cohort). The primary objective of the study is to evaluate the safety of Alpha DaRT in combination with chemotherapy, based on the cumulative incidence rate, severity and outcome of device related AEs.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Histologically and/or cytologically proven newly diagnosed locally advanced inoperable pancreatic adenocarcinoma (Cohort 1) OR histologically and/or...
- Patients will start treatment with mFOLFIRINOX (up to 4 cycles) before DaRT insertion
- Target lesion is technically amenable for Alpha DaRT sources implantation.
- Measurable lesion per RECIST (version 1.1) criteria
- Lesion size ≤ 5 cm in the longest diameter
You likely can't join if
- For Cohort 1 only: Borderline unresectable pancreatic cancer, and/or fit for surgical exploration unless patient refuses surgery.
- For Cohort 1 and Cohort 2: Prior treatment for pancreatic cancer, including chemotherapy except for 1 - 4 cycles of mFOLFIRINOX, radiation therapy...
- Known hypersensitivity to any of the components of the treatment.
- Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
- Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery...
- Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric...
See the full eligibility criteria
- Histologically and/or cytologically proven newly diagnosed locally advanced inoperable pancreatic adenocarcinoma (Cohort 1) OR histologically and/or cytologically proven newly diagnosed metastatic pancreatic...
- Patients will start treatment with mFOLFIRINOX (up to 4 cycles) before DaRT insertion
- Target lesion is technically amenable for Alpha DaRT sources implantation.
- Measurable lesion per RECIST (version 1.1) criteria
- Lesion size ≤ 5 cm in the longest diameter
- Interstitial radiation indication validated by a multidisciplinary team.
- ECOG Performance Status Scale 0 -2
- Life expectancy is more than 6 months
- WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
- Platelet count ≥60,000/μl
- Creatinine ≤1.9 mg/dL
- AST and ALT ≤ 2.5 X upper limit of normal (ULN)
- INR \< 1.4 for patients not on Warfarin
- Age ≥18 years old
- people are willing and able to sign an informed consent form
- Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after...
- Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after DaRT insertion.
- For Cohort 1 only: Borderline unresectable pancreatic cancer, and/or fit for surgical exploration unless patient refuses surgery.
- For Cohort 1 and Cohort 2: Prior treatment for pancreatic cancer, including chemotherapy except for 1 - 4 cycles of mFOLFIRINOX, radiation therapy, immunotherapy, etc.
- Known hypersensitivity to any of the components of the treatment.
- Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
- Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension...
- Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation...
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative...
- Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.
- Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after DaRT insertion.
- Volunteers participating in another treatment study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
- High probability of protocol non-compliance (in opinion of investigator).
- Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after DaRT insertion
- Patients who are at high risk of complications from radiation due to genetic conditions/mutations, inflammatory bowel disease, or connective tissue disease.
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Goodyear, Arizona, United States
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Cooperstown, New York, United States
- New York, New York, United States
- The Bronx, New York, United States
- Houston, Texas, United States
- Montreal, Quebec, Canada
- Jerusalem, Israel
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 - 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 to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Goodyear, Arizona, United States; Scottsdale, Arizona, United States; Los Angeles, California, United States; Orlando, Florida, United States; Atlanta, Georgia, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.