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Metastatic MelanomaFlash-Skin INCT06549439

eFLASH for Skin Lesions of Malignant Melanomas

A study testing Electron FLASH radiotherapy in people with Metastatic Melanoma, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective single center phase I trials aims to assess feasibility and safety of electron FLASH RT for treatment of melanoma skin metastases. Feasibility will be defined as FLASH delivery with an accuracy of +/-10% for each fraction, safety will be confirmed if a maximum of 2 out of 6 patients develop dose… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Melanoma
What is being tested?
Electron FLASH radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteSwitzerland
Study dates
27 Jan 2025to 30 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed study Informed Consent Form.
  • Males and females, age ≥ 18 years, no upper age limit.
  • 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.
  • The treated lesions must be at least 5 cm apart from each other, if applicable.
  • Lesions located on the scalp can be treated.
  • ECOG 0-2. Note: Patients may receive concurrent standard of care systemic treatment.

Who cannot join

  • Previous radiotherapy of the target lesions.
  • Ulcerated lesions may not be treated within the study. Patients may have ulcerated tumor lesions besides those selected for treatment within the trial.
  • 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.
  • 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).
  • Lesions should not be located directly on genitals.
  • 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.
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  • Women who are pregnant or breast feeding.
  • 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.
  • 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.
  • Enrollment of the investigator, his/her family members, employees and other dependent persons.
  • 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).
  • 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.
  • History of sun hypersensitivity or photosensitive dermatoses including porphyria, systemic lupus erythematosus, Sjögren's syndrome, xeroderma pigmentosum, polymorphous light eruptions.
  • Concomitant auto-immune disease with skin lesions.
  • Concomitant use of radio-sensitizer drug.
  • 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).
  • Concomitant use of systemic oncological treatment for another cancer than the metastatic melanoma.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital Zurich

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

About this study

Official title: A Phase I Clinical Study on Feasibility and Toxicity of LINAC-based Flash Radiotherapy for Palliative Treatment of Skin Lesions of Malignant Melanomas

This prospective single center phase I trials aims to assess feasibility and safety of electron FLASH RT for treatment of melanoma skin metastases. Feasibility will be defined as FLASH delivery with an accuracy of +/-10% for each fraction, safety will be confirmed if a maximum of 2 out of 6 patients develop dose limited toxicity.

Read the detailed description

Trial aim:

This prospective single center phase I trial aims to assess feasibility and safety of electron Flash RT for treatment of melanoma skin metastases. Feasibility will be defined as Flash delivery with an accuracy of ±10% for at least 10 out of 12 Flash-RT fractions and the accuracy of the total reference dose delivered (3x 9 Gy) is ±5%, safety will be confirmed if a maximum of 2 out of 6 patients develop dose-limiting toxicity.

Intervention Flash:

A nominal electron energy of 9 MeV will be used for both Flash-RT and Conv-RT, which guarantees ≥ 90% dose coverage up to a depth of 2.8 cm. Shallower lesions will be treated with the same electron energy and with a bolus. In order to treat these patients, field sizes between 2x2cm2 and 10x10cm2 will be used, which can be delivered with sufficient flatness (<5%) and symmetry (<2%) by the FlashTrueBeam v2.7.5.

Trial outline:

In the primary cohort, six patients with ≥ 1 melanoma skin lesion(s) (possible other lesions do not have to be treated) will be treated with a radiotherapy schedule of 3x 9 Gy (2x fractions/ week; α/β(3): EQD2: 64.8 Gy; α/β(10): EQD2: 42.75 Gy). A minimum of one lesion will be treated with Flash-RT (2x 9 Gy) and Conv-RT (1x 9 Gy) as experimental treatment and an optional minimum of one lesion will be treated with Conv-RT (3x 9 Gy) as "internal" control. As a consequence, also patients with a single lesion can be included into the trial. For the experimental treatment, the first two fractions will be applied with Flash-RT. Following dosimetry of these two fractions, the third fraction will be applied by Conv-RT and will be adjusted to compensate for possible lower or higher doses applied with Flash-RT before. This approach ensures that every lesion is treated with precisely a total reference dose of 27 Gy (± 5%), ultimately.

In an optional expansion cohort, up to 4 additional patients (total of n=10) will be recruited. The expansion cohort serves to further validate the primary results. The initiation of the expansion cohort requires to following three factors: 1. A maximum of 2 out of 6 patients develop DLT an no unexpected high-grade toxicity appear in the primary cohort; 2. Feasibility in the first six patients was shown (defined as Flash delivery with an accuracy of ±10% for at least 10 out of 12 Flash-RT fractions and the accuracy of the total reference dose delivered (3x 9 Gy) of ±5%); 3. No excessive duration in the recruitment of the primary cohort. Patients will be included and treated into the expansion cohort as in the primary cohort.

Being tested
Electron FLASH radiotherapy
Keywords
FLASH, Radiotherapy, Metastatic Melanoma
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electron FLASH radiotherapyRadiation

    A nominal electron energy of 9 MeV will be used for both Flash-RT and Conv-RT, which guarantees ≥ 90% dose coverage up to a depth of 2.8 cm. Shallower lesions will be treated with the same electron energy and with a bolus. In order to treat these patients, field sizes between 2x2cm2 and 10x10cm2 will be used, which can be delivered with sufficient flatness (<5%) and symmetry (<2%) by the FlashTrueBeam v2.7.5.

Study groups in NCT06549439
Study groupRoleWhat they receive
InterventionExperimentalA nominal electron energy of 9 MeV will be used for both Flash-RT and Conv-RT, which guarantees ≥ 90% dose coverage up to a depth of 2.8 cm. Shallower lesions will be treated with the same electron energy and with a bolus. In order to treat these patients, field sizes between 2x2cm2 and 10x10cm2 will be used, which can be delivered with sufficient flatness (<5%) and symmetry (<2%) by the FlashTrueBeam v2.7.5.
Receives: Radiation: Electron FLASH radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicity (Safety)

    H0: More than of 2 out of 6 patients in the primary study cohort (n=6) develop DLT in FLASH-irradiated lesions.

    H1: A maximum of 2 out of 6 patients in the primary study cohort (n=6) develop DLT in FLASH-irradiated lesions.

    Measured: 9 months

Secondary outcomes (5)

  1. Dose Accuracy (Feasibility)

    H0: More than of 2 out of 12 Flash-RT fractions in the primary study cohort (n=6) have dose deviation larger than +/- 10%

    H1: A maximum of 2 out of 12 Flash-RT fractions in the primary study cohort (n=6) have a doese deviation larger than +/- 10%

    Measured: 9 months

  2. Relief of Pain

    Pain will be assessed using an analogic visual pain scale (scale 0-10; 0=no pain, 10=worst pain)

    Measured: 21 months

  3. Relief of Hemorrhage

    Hemorrhage will be visually assessed by the investigator

    Measured: 21 months

  4. Local response assessment

    Local response and control of irradiated metastases will be measured as recording of clinical response assessment including photo documentation

    Measured: 9 months

  5. Late side effects

    Late side effects "in radiation field" (≥ 3 months an within 12 months post-treatment) will be measured as recording of late adverse events (CTCAE v5.0); and comparison of Flash- and Conv-irradiated lesions

    Measured: 21 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2024
  2. Study start27 Jan 2025
  3. Primary completion23 Jun 2025
  4. Study completion30 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06549439
Sponsor's protocol ID
Zurich Flash-Skin I
Acronym
Flash-Skin I
Status last verified
Oct 2026
First submitted
15 Mar 2024
Last updated
2 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dal Bello R, Psoroulas S, Fluckiger D, Krayenbuhl J, Moeckli R, Bailat C, Subiel A, Patallo IS, von der Grun J, Balermpas P, Guckenberger M, Tanadini-Lang S. The prospective phase I "Flash-Skin I" trial: ultra-high dose rate radiotherapy implementation and quality assurance at a clinical linear accelerator. Radiother Oncol. 2026 Mar;216:111372. doi: 10.1016/j.radonc.2026.111372. Epub 2026 Jan 9.

    PubMed 41520733

Questions about this trial

What is this clinical trial studying?

A study testing Electron FLASH radiotherapy in people with Metastatic Melanoma, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity (Safety) (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06549439, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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