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出境医 / 临床实验 / Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer
Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer
Study Description
Brief Summary:
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pancreatic Cancer Unresectable Pancreatic Cancer Metastatic Pancreatic Cancer Pancreatic Adenocarcinoma | Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) | Not Applicable |
Detailed Description:
This is a prospective, single-center, open label, single arm study. The study is designed to evaluate the feasibility, safety and preliminary efficacy of intratumoral alpha radiation mediated treatment with Alpha DaRT seeds for the treatment of advanced pancreatic cancer.
The study will be comprised of a screening period, DaRT insertion visit, acute follow-up phase of 4-6 weeks and a long-term follow up phase of 24 months. The total duration of the study will be 24 months from the DaRT insertion procedure.
30 patients with advanced pancreatic cancer will be recruited by the investigational site.
Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of DaRT seeds insertion. The patients will be monitored for a period of 24 months post insertion.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters on Advanced Pancreatic Cancer |
| Actual Study Start Date : | October 20, 2020 |
| Estimated Primary Completion Date : | October 2022 |
| Estimated Study Completion Date : | October 2024 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
|
Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
An intratumoral insertion of radioactive sources [Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
|
Outcome Measures
Primary Outcome Measures :
- Feasibility - DaRT seed placement [ Time Frame: Day 0 (Day of insertion) ]Assessment of the DaRT seed placement within the tumor or less than 5 mm from the tumor using CT imaging on the day of DaRT insertion.
- Safety - Adverse events [ Time Frame: 3 months ]Assessment of the frequency, severity and causality of acute AEs and SAEs related to DaRT seeds insertion. AEs and SAEs will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0
- Safety - Adverse events [ Time Frame: 3 to 24 months ]Assessment of the frequency, severity and causality of Late AEs and SAEs related to DaRT seeds insertion. AEs and SAEs will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The follow up will be carried out by phone calls every 2 months during the time between 3 to 24 months after DaRT seeds insertion
Secondary Outcome Measures :
- Efficiency - Short-term effect [ Time Frame: 4-6 weeks after DaRT seeds insertion ]Assessment of the objective response rate (ORR) following DaRT seeds insertion using CT scan
- Tissue damage evaluation [ Time Frame: Day -14 to 60 days after insertion ]Measuring CA19-9 as a marker to tissue damage. Elevation during treatment, and reduction as a result of tumor ablation. Serum levels of CA 19-9 can be measured using chemiluminescent assay on an Unicel DxI 800 analyzer (BeckmanCoulter, Brea, CA, USA).
- Efficiency - Long-term effect [ Time Frame: 2 years following DaRT seeds insertion ]Assessment of the overall survival (OS) following DaRT seeds insertion
- Stent durability [ Time Frame: Day of DaRT insertion up to 24 months. ]Stent durability will be assessed by the time elapsed from DaRT insertion to the need for follow-up referral for ERCP for stent change due to tumor ingrowth
- Change in quality of life: EORTC-QLQ-C30 [ Time Frame: Day -14 to 60 days after insertion ]Assessment of patient reported health-related Quality of Life (QoL) outcomes after DaRT treatment, using QoL questionnaires EORTC-QLQ-C30 (version 3.0). Scale range in score from 0 (best) to 100(worst).
- Change in quality of life: QLQ-PAN26 [ Time Frame: Day -14 to 60 days after insertion ]Assessment of patient reported health-related Quality of Life (QoL) outcomes after DaRT treatment, using QoL questionnaires QLQ-PAN26. The module comprises 26 questions assessing pain, dietary changes, jaundice, altered bowel habit, emotional problems related to pancreatic cancer, and other symptoms (cachexia, indigestion, flatulence, dry mouth, taste changes).
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Contacts
| Contact: Naama Barel | +972-3-618-24770 | Naamab@alphatau.com | |
| Contact: Amnon Gat | +1(617)435-6552 | Amnong@alphatau.com |
Locations
| Canada, Quebec | |
| Centre Hospitalier de l'Université de Montréal (CHUM) | Recruiting |
| Montréal, Quebec, Canada | |
| Contact: David Donath, MD | |
Sponsors and Collaborators
Alpha Tau Medical LTD.
Investigators
| Principal Investigator: | David Donath, MD | Brachytherapy Service Centre Hospitalier de l'Université de Montreal |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 16, 2019 | ||||||||
| First Posted Date ICMJE | June 28, 2019 | ||||||||
| Last Update Posted Date | March 17, 2021 | ||||||||
| Actual Study Start Date ICMJE | October 20, 2020 | ||||||||
| Estimated Primary Completion Date | October 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer | ||||||||
| Official Title ICMJE | A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters on Advanced Pancreatic Cancer | ||||||||
| Brief Summary | A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer. | ||||||||
| Detailed Description |
This is a prospective, single-center, open label, single arm study. The study is designed to evaluate the feasibility, safety and preliminary efficacy of intratumoral alpha radiation mediated treatment with Alpha DaRT seeds for the treatment of advanced pancreatic cancer. The study will be comprised of a screening period, DaRT insertion visit, acute follow-up phase of 4-6 weeks and a long-term follow up phase of 24 months. The total duration of the study will be 24 months from the DaRT insertion procedure. 30 patients with advanced pancreatic cancer will be recruited by the investigational site. Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of DaRT seeds insertion. The patients will be monitored for a period of 24 months post insertion. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
An intratumoral insertion of radioactive sources [Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
|
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| Study Arms ICMJE | Experimental: DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Intervention: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
30 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | October 2024 | ||||||||
| Estimated Primary Completion Date | October 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Canada | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04002479 | ||||||||
| Other Study ID Numbers ICMJE | AT-PANC-101 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Alpha Tau Medical LTD. | ||||||||
| Study Sponsor ICMJE | Alpha Tau Medical LTD. | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Alpha Tau Medical LTD. | ||||||||
| Verification Date | March 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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