Skip to main content
OpenTrials
Completed

NCT Number: NCT05125354

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell DaRT Treated Patients Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Davidof Cancer Institution at the Rabin Medical Center Israel, Petah Tikva, Israel

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. Adverse Events (AE)

    Time frame: Up to 60 months following DaRT insertion

    Assessment of late onset of Alpha DaRT related AE

Secondary outcomes

  1. 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

  2. Overall Survival (OS)

    Time frame: Up to 60 months following DaRT insertion

    Time from DaRT insertion to death

Sponsors and collaborators

Lead sponsor

Alpha Tau Medical LTD.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2021
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.