Alpha Radiation Emitters Device (DaRT) for the Treatment of Locally Advanced Pancreatic Cancer
NCT ID: NCT06755359
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2026-01-31
2027-06-30
Brief Summary
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Detailed Description
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Patients who have been previously treated with 8 - 12 cycles of mFOLFIRINOX will undergo DaRT insertion, with the goal of making their tumor resectable. Three (3) days after DaRT insertion, patients will begin taking Capecitabine for 2 months. Every 2 months after DaRT insertion, the patient will be assessed to determine if their tumor is surgically resectable, if they should continue with therapy, or if they should pause therapy. The trial will end 12 months after DaRT insertion.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Radioactive sources named Alpha DaRT sources: Ra - 224 coated onto titanium tubes inserted into the tumor.
Interventions
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Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Radioactive sources named Alpha DaRT sources: Ra - 224 coated onto titanium tubes inserted into the tumor.
Eligibility Criteria
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Inclusion Criteria
* Target lesion is technically amenable for Alpha DaRT sources implantation.
* Measurable lesion per RECIST (version 1.1) criteria
* Stable disease or tumor response per RECIST (version 1.1) criteria compared to before initiation of mFOLFIRINOX
* Lesion size ≤ 5 cm in the longest diameter
* Interstitial radiation indication validated by a multidisciplinary team which includes an oncologist, a radiation oncologist, radiologist, gastroenterologist and a surgeon specialized in pancreatic oncology in the case that a surgical emergency occurs during the procedure
* Patients have received 8 - 12 cycles of mFOLFIRINOX
* ECOG Performance Status Scale 0 - 1
* 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
* Subjects 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 initiation of Alpha DaRT therapy
* 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.
Exclusion Criteria
* Patients with metastatic disease
* Borderline unresectable pancreatic cancer, and/or cases fit for surgical exploration unless patient refuses surgery.
* 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, or history of myocardial infarction in the last 12 months.
* 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 with the requirements of the trial or interfere with the study endpoints.
* 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 therapy, low risk prostate cancer, or in situ cervical cancer.
* 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 discontinuing therapy.
* Volunteers participating in another interventional 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 RT.
18 Years
120 Years
ALL
No
Sponsors
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Alpha Tau Medical LTD.
INDUSTRY
Responsible Party
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Locations
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CHU de Bordeaux
Bordeaux, , France
CHU de Bordeaux
Bordeaux, , France
Centre Jean PERRIN - Clermont-Ferrand
Clermont-Ferrand, , France
Centre Georges François Leclerc Dijon
Dijon, , France
Centre Georges François Leclerc Dijon
Dijon, , France
Centre Georges François Leclerc Dijon
Dijon, , France
CHU Grenoble Alpes
Grenoble, , France
Hôpital Privé Mermoz - Lyon
Lyon, , France
Marseille
Marseille, , France
CHU Poitiers
Poitiers, , France
CHU Poitiers
Poitiers, , France
Gustave Roussy Institute
Villejuif, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CTP-PANC-04
Identifier Type: -
Identifier Source: org_study_id
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