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CompletedNCT05125354Updated Jun 1, 2022

A Retrospective Analysis to Evaluate Long Term Outcomes of SCC Patients Previously Treated With Alpha DaRT

An observational study in Squamous Cell Carcinoma and DaRT Treated Patients, sponsored by Alpha Tau Medical LTD.. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2022-06-01.

Sponsored by Alpha Tau Medical LTD. · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
33
Ages
18 Years to 120 Years
Sex
All
01

Study summary

Evaluation of long-term efficacy outcomes of patients previously treated with the Alpha DaRT seeds for management of their malignancy following initial response.

Read the detailed description

Medical records of patients that previously underwent the Alpha DaRT treatment will be reviewed by an authorized staff member.

Evaluation of long-term outcomes of patients previously treated with the Alpha DaRT seeds for management of their malignancy following initial response. These outcomes include:

  • Safety - assessment of late onset of Alpha DaRT related AE in patients treated with the Alpha DaRT seeds
  • Efficacy -

    • assessment of local recurrence rates in patients who achieved initial complete response (CR) following the Alpha DaRT treatment
    • assessment of duration of response in patients who achieved initial CR following the Alpha DaRT treatment
    • assessment of survival status in patients treated with the Alpha DaRT seeds
02

Conditions studied

  • Squamous Cell Carcinoma
  • DaRT Treated Patients

Keywords

  • Squamous Cell Carcinoma
  • Alpha Radiation
03

In context

Carcinoma, Squamous Cell

1,779 studies on the registry are indexed under Carcinoma, Squamous Cell; 409 are open to participants now.

This study's enrollment of 33 is below the median of 100 across 271 observational studies indexed under Carcinoma, Squamous Cell.

Browse Carcinoma, Squamous Cell studies →

Lead sponsor

Alpha Tau Medical LTD. is the lead sponsor of 29 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The medical records of patients previously treated with Alpha DaRT as part of the completed clinical trial "CTP-SCC-00" will be accessed to follow up with their status, if available.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients previously treated with the Alpha DaRT seeds for management of either skin or oral cavity SCC
  • Available information in medical charts and records (electronic or paper)

Exclusion criteria

Exclusion Criteria:

None.

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
33 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Progression Free Survival (PFS)

    Time from DaRT insertion to disease progression (according to RECIST V1.1) or death, whichever occurs first

    Time frame: Up to 60 months following DaRT insertion

  2. Adverse Events (AE)

    Assessment of late onset of Alpha DaRT related AE

    Time frame: Up to 60 months following DaRT insertion

Secondary outcomes

  1. Duration of Response

    Time from partial or complete response to the first disease progression according to RECIST V1.1

    Time frame: Up to 60 months following DaRT insertion

  2. Overall Survival (OS)

    Time from DaRT insertion to death

    Time frame: Up to 60 months following DaRT insertion

07

Study locations

2 sites
  • Davidof Cancer Institution at the Rabin Medical Center Israel
    Petah Tikva, 49100, Israel
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
    Meldola, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05125354
Responsible party
Sponsor
First posted
Nov 18, 2021
Start date
Jan 6, 2022
Primary completion
Mar 6, 2022
Completion
Mar 6, 2022
Last update
Jun 1, 2022

Study contacts

Noga Kurman, MD
principal investigator · Davidof Cancer Institution at Rabin Medical Center Israel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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