eFLASH for Skin Lesions of Malignant Melanomas
NCT06549439 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2025-07-28
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 limited toxicity.
Conditions
Interventions
- RADIATION
-
Electron FLASH radiotherapy
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.
Sponsors & Collaborators
-
Varian, a Siemens Healthineers Company
collaborator INDUSTRY -
University of Zurich
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-22
- Primary Completion
- 2025-05-27
- Completion
- 2026-07-31
Countries
- Switzerland
Study Locations
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