Treatment of advanced pancreatic cancer using alpha radiation emitters
A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters on Advanced Pancreatic Cancer
This study is testing a new type of radiation treatment for people with advanced pancreatic cancer to see if it can help them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 37 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alpha Tau Medical LTD. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 2 sites (Montréal, Quebec and 1 other locations) |
| Trial ID | NCT04002479 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility, safety, and preliminary efficacy of a novel treatment for advanced pancreatic cancer using intratumoral diffusing alpha radiation emitters (DaRT). It is a prospective, single-center, open-label, single-arm study involving 30 patients with unresectable or metastatic pancreatic adenocarcinoma. Participants will undergo a procedure for DaRT seed insertion, followed by a monitoring period of 24 months to assess treatment outcomes. The study aims to provide insights into this innovative radiation therapy approach for a challenging cancer type.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed locally advanced or metastatic pancreatic adenocarcinoma that is inoperable.
Not a fit: Patients with borderline resectable pancreatic cancer who are medically fit for surgery or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced pancreatic cancer who currently have limited treatment choices.
How similar studies have performed: While this approach is novel, other studies using radiation therapies for pancreatic cancer have shown varying degrees of success, indicating potential but untested efficacy for this specific method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically and/or cytologically proven locally advanced (Stage II or III) or metastatic (Stage IV) pancreatic, adenocarcinoma * Inoperable pancreatic cancer due to at least one of the following: a) unresectability, b) metastatic disease, c) medically unfit for surgery * ECOG performance status ≤ 2 * Measurable lesion per RECIST (version 1.1) criteria * Maximum lesion of 4cm in the longest diameter (including primary tumor and regional lymph nodes) * ≥ 18 years of age * Estimated life expectancy of at least 12 weeks * Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test * Subjects are willing to sign an informed consent Exclusion Criteria: * Prior chemotherapy does not exclude the patient * Prior abdominal radiation therapy * Concomitant chemotherapy or immunotherapy * Borderline resectable pancreatic cancer and medically fit for surgery * Connective tissue disease (scleroderma, lupus) * Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.) * Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids * 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) * Patients not willing to sign an informed consent form * Women who are pregnant or lactating
Where this trial is running
Montréal, Quebec and 1 other locations
- Centre Hospitalier de l'Université de Montréal (CHUM) — Montréal, Quebec, Canada (Recruiting)
- Jewish General Hospital — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: David Donath, MD — Brachytherapy Service Centre Hospitalier de l'Université de Montreal
- Study coordinator: Liron Dimnik
- Email: LironD@alphatau.com
- Phone: +972-2-373-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.