Can a flash of radiation tame melanoma skin lesions?
NCT ID NCT06549439
The trial has finished. Results may not be published yet.
First seen Aug 21, 2026 · Last updated Aug 21, 2026
Summary
This early-phase trial is testing whether an experimental form of radiation therapy, called FLASH, can safely treat skin lesions from metastatic melanoma. FLASH delivers radiation in a fraction of a second, which may spare healthy tissue while still targeting tumors. The study will enroll about 7 adults with melanoma skin metastases to see if the treatment is feasible and whether it causes severe side effects, while also checking if it helps with pain and bleeding.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- Electron FLASH radiotherapy
- What this could lead to
- If successful, this could offer a faster, safer way to relieve symptoms from melanoma skin lesions, potentially reducing side effects compared to standard radiation.
- What could go wrong
- This is a very early, small study (7 patients) focused on safety and feasibility. It may not show clear benefit, and there is a risk of dose-related toxicity.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
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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7 people
The number who actually took part.
- Started
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Jan 2024
- Finished
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Jun 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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. Signed study Informed Consent Form. 2. Males and females, age ≥ 18 years, no upper age limit. 3. Patients with metastatic melanoma and ≥ 1 skin/subcutaneous metastases (clearly definable in clinical examination: largest dimension of ≥ 5mm and ≤ 55 mm; ≤ 2.8 cm thickness (caliper-based measurement); volume ≤ 100ccm) with an indication for palliative radiotherapy of ≥ 1 skin/subcutaneous metastases according to the multidisciplinary tumorboard. 4. The treated lesions must be at least 5 cm apart from each other, if applicable. 5. Lesions located on the scalp can be treated. 6. ECOG 0-2. Note: Patients may receive concurrent standard of care systemic treatment. Exclusion criteria: 1. Previous radiotherapy of the target lesions. 2. Ulcerated lesions may not be treated within the study. Patients may have ulcerated tumor lesions besides those selected for treatment within the trial. 3. Lesions, for which a homogeneous dose distribution inside the tumor D95%\> 95% - D2% \<107% for the PTV (acceptable deviation D90%\> 80% - D2% \<115%) in the treatment planning system cannot be achieved. 4. Lesions should not be located on the face. Lesions on the forehead located cranially from a line situated 1 cm above the eyebrows can be treated (=cranial of sinus frontalis). 5. Lesions should not be located directly on genitals. 6. Lesions with close proximity to air-filled cavities or air-filled, luminal organs (e.g. bowel). Close proximity is defined by intersection of the respective part of the organ at risk with the 80% isodose line of the lesion planned for radiotherapy. 7. Women who are pregnant or breast feeding. 8. Lack of safe contraception during the study, defined as: Female participants of childbearing potential and male participants with partner of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. 9. Known or suspected non-compliance, drug or alcohol abuse, inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, previous enrollment into the current study. 10. Enrollment of the investigator, his/her family members, employees and other dependent persons. 11. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Not adequately controlled HIV disease (HIV-viral load detectable). 12. Other severe comorbidities or psychiatric disorders (e.g. myocardial infraction within 6 months prior to registration, permanent cardiac arrhythmia, COPD Gold IV, schizophrenia, ongoing alcohol abuse) that would, according to the evaluation of the investigator, limit compliance with study requirement, substantially increase the risk of incurring adverse events or compromise the ability of the patient to give written informed consent. 13. History of sun hypersensitivity or photosensitive dermatoses including porphyria, systemic lupus erythematosus, Sjögren's syndrome, xeroderma pigmentosum, polymorphous light eruptions. 14. Concomitant auto-immune disease with skin lesions. 15. Concomitant use of radio-sensitizer drug. 16. Current, recent (within 10 days prior to start of study treatment), or planned participation in an experimental drug study (before end of treatment (EOT) visit). 17. Concomitant use of systemic oncological treatment for another cancer than the metastatic melanoma.
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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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University Hospital Zurich
Zurich, Canton of Zurich, 8091, Switzerland
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