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

Completed

• Conditions: DaRT Treated Patients; Squamous Cell Carcinoma

• Registration Number: NCT05125354
• Lead Sponsor: Alpha Tau Medical LTD.

Brief Summary

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

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 Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-11-08
• Study First Posted: 2021-11-18
• Study Start: 2022-01-06
• Primary Completion: 2022-03-06
• Study Completion: 2022-03-06
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.); 🇮🇹 Meldola, Italy

Davidof Cancer Institution at the Rabin Medical Center Israel; 🇮🇱 Petah tikva, Israel