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Recruiting NCT04068155

Alpha Radiation Emitters Device (DaRT) for the Treatment of of Malignant Cutaneous Tumors

No phase Interventional Skin Cancer Cutaneous Tumor Cutaneous Metastasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DaRT- Diffusing Alpha-emitters Radiation Therapy.
Who it may be relevant to
Registry conditions: Skin Cancer, Cutaneous Tumor, Cutaneous Metastasis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous Tumors

Overview

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors

Detailed description

This will be a prospective, open label, single arm, multi- center study, assessing the safety and effectiveness of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.

This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.

Cutaneous lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.

Reduction in tumor size 9-11 weeks following DaRT insertion will be assessed. Safety will be assessed by the frequency, severity and causality of all Adverse Events (AE).

Interventions

  • Device DaRT- Diffusing Alpha-emitters Radiation Therapy
    Seed(s) loaded with Radium-224 for local intratumoral irradiation with the destructive power of alpha particles

Primary outcome measures

  • The objective response rate to DaRT treatment [Time frame: up to 9-11 weeks]
Secondary outcome measures (5)
  • Tumor volume [Time frame: up to 9-11 weeks]
  • DaRT seeds placement [Time frame: Day of DaRT insertion procedure]
  • Change in quality of life as assessed by the Skindex-16 questionnaire [Time frame: up to 9-11 weeks]
  • Disease-Free Survival (DFS) rate [Time frame: up to 24 months]
  • Change in quality of life as assessed by the Skin Cancer Index (SCI) questionnaire [Time frame: up to 9-11 weeks]

Eligibility criteria

Inclusion criteria

  • Subjects with histopathological confirmation of newly diagnosed (Cohort A) or locally recurrent (Cohort B) malignant cutaneous lesions of the following histopathologies:
  • SCC
  • BCC
  • Lentigo maligna melanoma (Dubreuilh melanoma)
  • Carcinosarcoma
  • Acceptable tumor locations include the following:
  • Skin (facial, scalp, extremities, torso)
  • Lips
  • Eyelids
  • Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
  • Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds.
  • Measurable disease according to RECIST v1.1.
  • Subjects over 18 years old.
  • Subjects' ECOG Performance Status Scale is < 2.
  • Subjects' life expectancy is more than 6 months.
  • Platelet count ≥100,000/mm3.
  • International normalized ratio of prothrombin time ≤1.8.
  • Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
  • Subjects are willing to sign an informed consent form

Exclusion criteria

  • Subject has a tumor with histology of one of the following:
  • Keratoacanthoma
  • Merkel cell carcinoma
  • Sarcoma other than carcinosarcoma
  • Metastatic disease (according to the TNM staging system - M1 patients are excluded)
  • Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.).
  • Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
  • Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
  • High probability of protocol non-compliance (in opinion of investigator).
  • Subjects not willing to sign an informed consent.
  • Women who are pregnant or breastfeeding.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 2 centers
  • CHU Grenoble Alpes — Grenoble
  • Centre Léon Bérard — Lyon

Identifiers

NCT: NCT04068155 · CTP-MCT-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗