An interventional study of FLASH therapy in Metastasis From Malignant Melanoma of Skin (Diagnosis), sponsored by Centre Hospitalier Universitaire Vaudois. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Centre Hospitalier Universitaire Vaudois · Not applicable, Interventional, and Treatment
This is a single center phase I, first-in-human, dose escalation study of FLASH therapy in patients with metastases of melanoma.
The trial is based on escalating single doses of FLASH therapy administered to skin melanoma metastases using the Mobetron® with high dose rate (HDR) functionality.
The aim of the study is to evaluate a dose escalation of high dose rate radiotherapy (FLASH therapy) as single dose treatment for skin melanoma metastases that progress locally despite systemic treatments. Melanoma is a typically radio-resistant tumor type, which can justify such a dose escalation with a new type of radiotherapy that appears much better tolerated than conventional radiotherapy.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's planned enrollment of 46 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Centre Hospitalier Universitaire Vaudois is the lead sponsor of 203 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
7 dose levels (22 Gy; 24 Gy; 26 Gy; 28 Gy, 30 Gy, 32 Gy and 34 Gy)
Device: FLASH therapy
7 dose levels (22 Gy; 24 Gy; 26 Gy; 28 Gy, 30 Gy, 32 Gy and 34 Gy)
Device: FLASH therapy
Dose escalation of high dose rate radiotherapy (FLASH therapy) as single dose treatment for skin melanoma metastases that progress locally despite systemic treatments.
Also known as: high dose rate radiotherapy
Determination of maximum tolerated dose (MTD) or recommended phase II dose (RP2D), separately for skin metastases of small and large volumes.
Acute safety (dose limiting toxicity, DLT) of the high dose rate radiotherapy (RT) procedure (for each dose level) will be evaluated during the 4 weeks post-treatment using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Time frame: from Day 1 to Day 28
Percentage of patients with Hemorrhage related to the treated lesions, assessed visually by the investigator
Hemorrhage will be visually assessed (presence/abscence)
Time frame: At each visit, from screening to 12 months post-treatment
Percentage of patients with Skin ulceration related to the treated lesions, assessed visually by the investigator
Skin ulceration will be visually assessed (presence/abscence)
Time frame: At each visit, from screening to 12 months post-treatment
Percentage of patients with Pain related to the treated lesions, assessed with analogic visual pain scale
Pain will be assessed using an analogic visual pain scale (score from 1 to 10)
Time frame: At each visit, from screening to 12 months post-treatment
Local response of metastases "in the radiation field", measured with calipers
Irradiated lesions will be measured with calipers. Local response of metastases in the radiation field will be calculated as rate over all treated lesions and will be compared between small versus large volume lesions within each dose level.
Time frame: At screening, Day 1, at weeks 1, 3, 4, and 6 post-treatment; at months 3, 6, and 12 post-treatment; and at local progression
Frequency of Late side effects observed "in radiation field"
Time frame: ≥ 6 months post-treatment
Blinded Imaging Central Review (BICR) of photographs evaluating both tumor response and "in radiation field" normal tissue responses around the treated tumors
A baseline photograph will be taken the day of the treatment in a pre-therapeutic setting with skin delineation of the lesion. Then photos will be repeated at 1 (+/-2d), 3 (+/-2d), 4 (+/-3d), 6 (+/-3d) weeks after treatment, then at 3 (+/-7d), 6 (+/-14d), 12 (+/-14d) months and at progression.
Time frame: From Day 1 up to 12 months post-treatment
Optical coherence tomography (OCT) examination of the irradiated skin compared to the normal non-irradiated skin
Epidermis thickness and roughness; plexus depth; number and size of vessels; number and size of hairs, will be compared between irradiated skin and normal non-irradiated skin
Time frame: at 4 weeks, 6 months and 12 months post-treatment
Frequency of late adverse events (within 12 months post-treatment) for each dose
Long-term safety of RT procedure will be measured as recording of late adverse events (CTCAE v5.0)
Time frame: within 12 months post-treatment
Observation of a potential Abscopal Effect with evidence of tumor regression on metastases outside of the radiation field, measured with a caliper for cutaneous lesion or on radiological images for other lesions
Observation of a potential Abscopal Effect with evidence of tumor regression on metastases outside of the radiation field, measured with a caliper for cutaneous lesion or on radiological images for other lesions
Time frame: within 12 months post-treatment (at 1, 3, 4, 6 weeks post-treatment; at 3, 6, 12 months post-treatment; at progression)
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Centre Hospitalier Universitaire Vaudois