Pancreatic CancerNCT06755359
Alpha Radiation Emitters Device (DaRT) for the Treatment of Locally Advanced Pancreatic Cancer
A study testing Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) in people with Pancreatic Cancer and Locally Advanced Pancreatic Cancer, run by Alpha Tau Medical LTD. at 12 sites in France.
Trial summary
A unique approach for cancer treatment including radioactive sources named Alpha DaRT sources: Ra - 224 coated onto stainless steel tubes inserted into the tumor for the treatment of Locally Advanced Pancreatic Cancer . Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Pancreatic Cancer, Locally Advanced Pancreatic Cancer
- What is being tested?
- Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 12 sitesFrance
- Study dates
- 1 Mar 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically and/or cytologically proven locally advanced pancreatic adenocarcinoma
- 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
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- 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.
Who cannot join
- Concomitant immunotherapy within the past 4 weeks.
- 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.
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- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
France12 sites, 12 recruiting
- Not yet recruiting
CHU de Bordeaux
Bordeaux
Brieuc Bernard, brieuc.bernard@chu-bordeaux.fr
- Not yet recruiting
CHU de Bordeaux
Bordeaux
Aurore Salvaudon, aurore.salvaudon@chu-bordeaux.fr
- Not yet recruiting
Centre Jean PERRIN - Clermont-Ferrand
Clermont-Ferrand
Veronique DEDIEU, veronique.dedieu@clermont.unicancer.fr
- Not yet recruiting
Centre Georges François Leclerc Dijon
Dijon
Lydie HOUOT, lhouot@cgfl.fr
- Not yet recruiting
Centre Georges François Leclerc Dijon
Dijon
Aurelie PETITFILS, apetitfils@cgfl.fr
- Not yet recruiting
Centre Georges François Leclerc Dijon
Dijon
Leone AUBIGNAC, laubignac@cgfl.fr
- Recruiting
CHU Grenoble Alpes
Grenoble
Jean-Yves Giraud, jygiraud@chu-grenoble.fr
- Not yet recruiting
Hôpital Privé Mermoz - Lyon
Lyon
Mustapha Khodri, khodri1@yahoo.fr
- Not yet recruiting
Marseille
Marseille
Julien Darreon, darreonj@ipc.unicancer.fr
- Not yet recruiting
CHU Poitiers
Poitiers
Aurelie SORS, lhouot@cgfl.fr
- Not yet recruiting
CHU Poitiers
Poitiers
Eric DAVID, eric.david@chu-poitiers.fr
- Not yet recruiting
Gustave Roussy Institute
Villejuif
Pauline Maury, +33674218420, pauline.maury@gustaveroussy.fr
About this study
Official title: A Safety Study of Intratumoral Diffusing Alpha Radiation Emitters With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer
A unique approach for cancer treatment including radioactive sources named Alpha DaRT sources: Ra - 224 coated onto stainless steel tubes inserted into the tumor for the treatment of Locally Advanced Pancreatic Cancer .
Read the detailed description
This study will be a prospective, interventional, open label, single arm, multiple center study.
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.
- Being tested
- Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
- Keywords
- Alpha radiation, pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)Device
Radioactive sources named Alpha DaRT sources: Ra - 224 coated onto titanium tubes inserted into the tumor.
| Study group | Role | What they receive |
|---|---|---|
| DaRT Seeds | Experimental | Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds Receives: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Serious adverse events
Safety will be determined according to the overall incidence of device related SAEs with severity graded according to CTCAE v5.0 criteria
Measured: from Day 0 , up to 12 months
Secondary outcomes (5)
Efficacy - tumor response
to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to Objective tumor response rate according to RECIST 1.1
Measured: Day 0 , up to 12 months
Efficacy - overall survival
to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to Overall survival
Measured: Day 0 , up to 12 months
Efficacy - Progression-free survival
to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to - Progression-free survival
Measured: Day 0 , up to 12 months
Efficacy - Percentage of R0/R1 resected patients
to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to Percentage of R0/R1 resected patients
Measured: Day 0 , up to 12 months
Efficacy - percentage of patients with tumors that became surgically respectable after DaRT treatment
to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to percentage of patients with tumors that became surgically respectable after DaRT treatment
Measured: Day 0 , up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Mar 2026
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Alpha Tau Medical LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alpha Tau Medical LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755359
- Sponsor's protocol ID
- CTP-PANC-04
- Status last verified
- Nov 2025
- First submitted
- 19 Dec 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Study of Intratumoral Diffusing Alpha Radiation Emitters With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06755359
- Acronym / sponsor ID
- CTP-PANC-04
- Keywords
- Alpha radiation, pancreatic cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Alpha Tau Medical LTD.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A unique approach for cancer treatment including radioactive sources named Alpha DaRT sources: Ra - 224 coated onto stainless steel tubes inserted into the tumor for the treatment of Locally Advanced Pancreatic Cancer .
Detailed description
This study will be a prospective, interventional, open label, single arm, multiple center study.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DaRT Seeds | Experimental | Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically and/or cytologically proven locally advanced pancreatic adenocarcinoma
- 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
Key exclusion criteria (13 listed)
- Concomitant immunotherapy within the past 4 weeks.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)Radioactive sources named Alpha DaRT sources: Ra - 224 coated onto titanium tubes inserted into the tumor. | Device | DaRT Seeds |
Primary outcome
Safety - Serious adverse events
Time frame: from Day 0 , up to 12 months
Safety will be determined according to the overall incidence of device related SAEs with severity graded according to CTCAE v5.0 criteria
5 secondary outcomes
Efficacy - tumor response
Time frame: Day 0 , up to 12 months
Efficacy - overall survival
Time frame: Day 0 , up to 12 months
Efficacy - Progression-free survival
Time frame: Day 0 , up to 12 months
Efficacy - Percentage of R0/R1 resected patients
Time frame: Day 0 , up to 12 months
Efficacy - percentage of patients with tumors that became surgically respectable after DaRT treatment
Time frame: Day 0 , up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) in people with Pancreatic Cancer and Locally Advanced Pancreatic Cancer, run by Alpha Tau Medical LTD. at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liron Dimnik (972-54-2688602, LironD@alphatau.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Serious adverse events (time frame: from Day 0 , up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.