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NCT05125354 Clinical Trial

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

Squamous Cell Carcinoma Clinical Trial

Official title:
A Retrospective Analysis to Evaluate Long Term Outcomes of Squamous Cell Carcinoma Patients Previously Treated With Alpha Diffusing Alpha-emitters Radiation Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05125354
Other study ID # CTP-SCC-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 6, 2022
Est. completion date March 6, 2022

Study information
Verified date October 2021
Source Alpha Tau Medical LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date March 6, 2022
Est. primary completion date March 6, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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: None.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Davidof Cancer Institution at the Rabin Medical Center Israel Petah tikva
Italy Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) Meldola

Sponsors (1)
Lead Sponsor Collaborator
Alpha Tau Medical LTD.

Countries where clinical trial is conducted

Israel,  Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression Free Survival (PFS) Time from DaRT insertion to disease progression (according to RECIST V1.1) or death, whichever occurs first Up to 60 months following DaRT insertion
Primary Adverse Events (AE) Assessment of late onset of Alpha DaRT related AE Up to 60 months following DaRT insertion
Secondary Duration of Response Time from partial or complete response to the first disease progression according to RECIST V1.1 Up to 60 months following DaRT insertion
Secondary Overall Survival (OS) Time from DaRT insertion to death Up to 60 months following DaRT insertion
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