New radiation treatment shows promise for tough skin cancers
NCT ID NCT05323253
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new type of radiation therapy, called DaRT, for people with recurrent squamous cell skin cancer that has not responded to standard treatments. About 86 participants will receive the treatment directly into their tumors. The main goals are to see if the tumors shrink and how long that effect lasts.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 86 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2022
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with recurrent cutaneous SCC histologically confirmed who have failed at least first line standard of care therapy who are not indicated for surgery and standard radiation therapy, or non alpha radiation brachytherapy technologies, and for whom no curative systemic treatment is available 2. Central histopathological confirmation within 6 months of enrollment provided no tumor treatment occurred between the biopsy and enrollment 3. Measurable disease according to RECIST v 1.1. 4. Ability to undergo a CT scan 5. Tumor size ≤7 cm, at the longest diameter. 6. Single lesion per subject. 7. Targeted lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds.Targets will be deemed technically amenable for complete coverage if there are entry and exit vectors for placement that are not hindered by bone or major vessels or other vital organs (eg. eye). 8. Interstitial implant indication validated by multidisciplinary team. 9. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2. 10. Life expectancy ≥12 months. 11. Subjects male/ female ≥18. 12. Willing and have the ability to provide signed Informed Consent. 13. Patients, male and female, with reproductive potential (including women who are menopausal for less than a year and not surgically sterilized), must practice acceptable effective methods of birth control, such as barrier methods, condom or diaphragm with spermicide or abstinence. Birth control should be continued for 3 months after the DaRT insertion visit. 14. Women with childbearing potential must provide a negative pregnancy test during the screening period and up to V1, prior to the DaRT insertion procedure. 15. Blood tests values: * Leucocytes ≥3000mm3, * Absolute neutrophil count ≥1500mm3, * Platelets ≥100,000 mm3, * Total bilirubin ≤ 1.5xULN (upper limit of normal) * Aspartate Aminotransferase (AST) ≤2.5xULN, * Serum Glutamic-Oxaloacetic Transaminase (SGOT) ≤2.5xULN, * Serum Glutamic-Pyruvic Transaminase (SGPT) ≤2.5xULN, * Alkaline Phosphatase ≤2.5xULN. * Creatinine ≤ 2.0xULN or Creatinine Clearance ≥60 ml/min. * INR (International Normalized Ratio) or Prothrombin time ≤1.5xULN. Exclusion Criteria: 1. Distant or nodal metastatic disease (according to the TNM \[tumor, nodes , and metastases\] staging system - N+ or M1 patients are excluded). 2. T4 disease or perineural spread of disease 3. Previously untreated cutaneous SCC indicated for surgery or radiation. 4. Mucosal, vulvar, anal and penile SCC. 5. Inability to fully cover the entire volume with DaRT seeds 6. Inability to place DaRT seeds into tumor due to inaccessibility by presence of bones or major vessels or vital organs 7. Inability to undergo a CT scan 8. Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids. 9. Patients receiving any of the following within 4 weeks of enrollment: 1. Antineoplastic systemic chemotherapy or biological therapy 2. Immunotherapy 3. Investigational agents other than the study intervention 4. Radiation therapy 5. Live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial. 10. Longest tumor diameter \>7 cm. 11. Tumor with keratoacanthoma histology. 12. Known hypersensitivity to any component of treatment. 13. Clinically significant cardiovascular disease e.g., cardiac failure of New York Heart Association class III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, history of myocardial infarction in the last 12 months. 14. Any medical or Psychiatric illness, which in the opinion of the investigator would compromise the patient's ability to tolerate treatment and to adhere to the clinical trial protocol. 15. Serious medical comorbidities that, in the opinion of the investigator, may affect subject compliance and/or interpretation of treatment safety or effectiveness. 16. High probability of protocol non-compliance (in opinion of investigator). 17. 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. 18. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 19. Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry and for 3 months after the DaRT insertion visit. 20. Breastfeeding or pregnant women 21. Tattoos or other identifying marks which can not be adequately hidden on digital photos
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Alliance Dermatology
Phoenix, Arizona, 85032, United States
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Banner Health MD Anderson Phoenix
Gilbert, Arizona, 85234, United States
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Baptist Health South Florida MCI
Miami, Florida, 33176, United States
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Bassett Healthcare Network
Cooperstown, New York, 13326, United States
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Beer Dermatology
West Palm Beach, Florida, 33401, United States
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Belinson-Rabin Medical Center
Petah Tikva, Israel
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Day Star Skin and Cancer Center
DeLand, Florida, 32720, United States
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Dermatology of Seattle and Bellevue
Bellevue, Washington, 98004, United States
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Dignity Health Cancer Institute
Phoenix, Arizona, 85004, United States
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Emory University
Atlanta, Georgia, 30308, United States
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Gulf Coast Cancer Center
Houston, Texas, 77008, United States
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Hadassah Medical Center
Jerusalem, 9777605, Israel
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Hollywood Dermatology
Hollywood, Florida, 33021, United States
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Integrity Research Clinical Associates
Delray Beach, Florida, 33445, United States
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MDCS Dermatology
Smithtown, New York, 11787, United States
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Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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New Mexico Cancer Center
Albuquerque, New Mexico, 87109, United States
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New York Medical Skin Solutions
Rockaway Park, New York, 11694, United States
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Northwell Health
Queens, New York, 11375, United States
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Palm beach Dermatology Group
Delray Beach, Florida, 33484, United States
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Princess Margaret Cancer Center
Toronto, Ontario, Canada
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Rambam Medical Center
Haifa, Israel
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Schweiger Dermatology Group
Hackensack, New Jersey, 07601, United States
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Sheba Medical Center
Ramat Gan, Israel
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UCLA
Los Angeles, California, 90095, United States
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University Cancer & Diagnostic Center
Houston, Texas, 77089, United States
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University of Miami
Miami, Florida, 33101, United States
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