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

May 30, 2022 updated by: Alpha Tau Medical LTD.

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

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

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) Time Frame: Up to 60 months following DaRT insertion	Time from DaRT insertion to disease progression (according to RECIST V1.1) or death, whichever occurs first	Up to 60 months following DaRT insertion
Adverse Events (AE) Time Frame: Up to 60 months following DaRT insertion	Assessment of late onset of Alpha DaRT related AE	Up to 60 months following DaRT insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response Time Frame: Up to 60 months following DaRT insertion	Time from partial or complete response to the first disease progression according to RECIST V1.1	Up to 60 months following DaRT insertion
Overall Survival (OS) Time Frame: Up to 60 months following DaRT insertion	Time from DaRT insertion to death	Up to 60 months following DaRT insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alpha Tau Medical LTD.

Investigators

Principal Investigator: Noga Kurman, MD, Davidof Cancer Institution at Rabin Medical Center Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2022

Primary Completion (Actual)

March 6, 2022

Study Completion (Actual)

March 6, 2022

Study Registration Dates

First Submitted

November 8, 2021

First Submitted That Met QC Criteria