This is a multi-center clinical study enrolling up to 86 participants. The primary objectives are to determine the objective response rate (ORR) established by the confirmed best overall response (BOR) following intratumoral administration of DaRT - Diffusing Alpha-Emitters Radiation Therapy, as well as to assess the Duration of Response (DOR) 6 months from initial response. Secondary objectives are to assess the safety of DaRT, and to assess the progression free survival (PFS), overall survival (OS), Overall Duration of Response (O-DOR), local control and quality of life (QOL) for patients treated with DaRT.
This study is a prospective multicenter, pivotal, single arm, open label clinical study to assess the efficacy and safety of intratumoral Alpha DaRT-224 for the treatment of patients with recurrent cutaneous squamous cell carcinoma. The "Diffusing Alpha-emitter Radiation Therapy (DaRT)", based on the interstitial intratumoral placement of an encapsulated Radium-224 source (3.7 days half-life), is described in this study. These sources release short-lived alpha-emitting atoms into the tumor microenvironment by recoil. DaRT seeds will be inserted into recurrent Squamous Cell Carcinoma (SCC) tumors and will be removed following 14-21 days. The Objective Response Rate (ORR) will be determined based on the confirmed Best Overall Response (BOR) following DaRT insertion. Duration of Response (DOR) will be assessed for up to 6 months from initial response is documented. Safety will be assessed based on the cumulative incidence rate, severity and outcome of device related Adverse Events (AEs). Classification of AEs will be done according to CTCAE v5.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
86
DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed.
Banner Health MD Anderson Phoenix
Gilbert, Arizona, United States
Dignity Health Cancer Institute
Phoenix, Arizona, United States
Alliance Dermatology
Phoenix, Arizona, United States
UCLA
Los Angeles, California, United States
Day Star Skin and Cancer Center
DeLand, Florida, United States
Integrity Research Clinical Associates
Delray Beach, Florida, United States
Palm beach Dermatology Group
Delray Beach, Florida, United States
Hollywood Dermatology
Hollywood, Florida, United States
University of Miami
Miami, Florida, United States
Baptist Health South Florida MCI
Miami, Florida, United States
...and 18 more locations
Objective Response Rate
Objective Response Rate (ORR) of DaRT as treatment for Recurrent SCC established by the confirmed Best Overall Response (BOR), with confirmation at least 4 weeks after initial assessment
Time frame: From Day 14 until 52 weeks
Duration of Response
Assess the Duration of Response (DOR) of DaRT as treatment for Recurrent SCC
Time frame: 6 months from from first demonstration of CR or PR after Alpha DaRT seeds insertion.
Progression Free Survival
Determine Progression Free Survival (PFS) of SCC following DaRT treatment
Time frame: Up to 12 months after DaRT seed insertion
Overall Survival
Assess Overall Survival (OS) of Recurrent SCC patients treated with DaRT
Time frame: Up to 12 months following DaRT insertion
Time of Local Control
Local control of SCC following DaRT treatment is measured as the time from first recorded response (Complete Response/Partial Response/Stable Disease) to local recurrence up to 12 months or last follow up
Time frame: Up to 12 months following DaRT insertion
Patients Quality of Life Assessment
Assess patient reported health related quality of life (QOL) outcomes using the Skin Cancer Index (SCI) and Skindex-16 questionnaires
Time frame: On 14 days,12 weeks and 52 weeks following DaRT insertion
DaRT-related Adverse Events
Assess the safety of the Alpha DaRT treatment, based on the cumulative incidence rate, severity and outcome of device related AEs. Classification of AEs will be done according to CTCAE v5
Time frame: Up to 12 months following DaRT insertion
Overall Duration of Response (O-DOR)
O-DOR Defined as the time from first response (CR or PR) to the date of initial objectively documented progression or death due to any cause, whichever occurs first.
Time frame: Up to 12 months following first reported response
User experience
Assess user experience as determined by questionnaire
Time frame: On Day 0 (DaRT insertion) and Day 14 (+7) (DaRT removal)
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