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Alpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Cutaneous Squamous Cell Carcinoma

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary and study completion dates: Dec 2025 to Apr 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 30 to 28
    • Study title shortened, about 9 words
    v27
  2. Study sites: 31 to 30v26
  3. Site details revised at 2 of 31 sitesv25
  4. Primary completion date: Dec 2024 to Dec 2025v24
  5. Study sites: 26 to 31v23
Show 21 earlier versionsHide 21 earlier versions
  1. Study sites: 28 to 26v22
  2. Site details revised at 7 of 28 sitesv21
  3. Study sites: 26 to 28v20
  4. Re-verified, no change to tracked fieldsv19
  5. Site details revised at 1 of 26 sitesv18
  6. Study sites: 25 to 26v17
  7. Site details revised at 2 of 25 sitesv16
  8. Site details revised at 2 of 25 sitesv15
  9. Site details revised at 2 of 25 sitesv14
  10. Study sites: 17 to 25v13
  11. Re-verified, no change to tracked fieldsv12
  12. Site details revised at 2 of 17 sitesv11
  13. Site details revised at 1 of 17 sitesv10
  14. Study sites: 12 to 17v9
  15. Site details revised at 1 of 12 sitesv8
  16. Re-verified, no change to tracked fieldsv7
  17. Study sites: 3 to 12v6
  18. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 3
    • Start date changed from estimate of Nov 2022 to Sep 21, 2022
    v5
  19. Study sites: 0 to 1v4
  20. Start date: Jun 2022 to Nov 2022
    • Eligibility criteria expanded, about 15 words
    • Study description expanded, about 4 words
    v3
  21. Eligibility criteria expanded, about 165 words
    • Secondary endpoints: 5 to 7
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 86 participants. The primary objectives are to determine the objective response rate (ORR) established by the confirmed best overall response (BOR) following intratumoral administration of DaRT - Diffusing Alpha-Emitters Radiation Therapy, as well as to assess the Duration of Response (DOR) 6 months from initial response. Secondary objectives are to assess the safety of DaRT, and to assess the progression free survival (PFS), overall survival (OS), Overall Duration of Response (O-DOR), local control and quality of life (QOL) for patients treated with DaRT.
Trial Details
NCT Number NCT05323253
Lead Sponsor Alpha Tau Medical LTD.
Conditions
(from sponsor)		 Recurrent Squamous Cell Carcinoma
Related terms Carcinoma, Squamous Cell, Skin Neoplasms
Enrollment 86 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov