Alpha Radiation Emitters Device for the Treatment of of Malignant Cutaneous Tumors (NCT04068155) | Clinical Trial Compass
RecruitingNot Applicable
Alpha Radiation Emitters Device for the Treatment of of Malignant Cutaneous Tumors
France80 participantsStarted 2022-04-01
Plain-language summary
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 us…