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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05125354

Enrollment

Registered

2021-11-18

Start date

2022-01-06

Completion date

2022-03-06

Last updated

2022-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DaRT Treated Patients, Squamous Cell Carcinoma

Keywords

Squamous Cell Carcinoma, Alpha Radiation

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Israel, Italy

Outcome results