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Alpha Radiation Emitters (DaRT) With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment increased: 40 → 50 participants
    • Secondary endpoints: 3 to 4
    v13
  2. Enrollment target: 40 to 50
    • Secondary endpoints: 2 to 3
    v12
  3. Site details revised at 3 of 15 sites
    • Study title shortened, about 1 word
    v11
  4. Enrollment increased: 30 → 40 participants
    • Study description expanded, about 26 words
    • Site details revised at 2 of 15 sites
    v10
  5. Study title shortened, about 5 wordsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 16 to 15v8
  2. Study title shortened, about 1 wordv7
  3. Site details revised at 2 of 16 sitesv6
  4. Site details revised at 1 of 16 sitesv5
  5. Study sites: 8 to 16v4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 8
    • Start date changed from estimate of Apr 2025 to Jun 17, 2025
    v3
  7. Start date: Dec 2024 to Apr 2025
    • Secondary endpoints: details revised at 1 of 2 entries
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a multi-center clinical study enrolling up to 50 participants. 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. Classification of AEs will be done according to CTCAE V6. The secondary objectives of the study are to: * Assess efficacy of the Alpha DaRT sources in combination with chemotherapy, determined by overall and progression-free survival. * Assess pain control * Assess rate of surgical resection in Cohort 1.
Trial Details
NCT Number NCT06698458
Lead Sponsor Alpha Tau Medical LTD.
Conditions
(from sponsor)		 Pancreatic Cancer, Pancreatic Adenocarcinoma, Metastatic Pancreatic Cancer
Related terms Pancreatic Neoplasms
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov