NCT04986696

Irradiation of Melanoma in a Pulse

A Phase I, First-in-human, Dose Finding Study of High Dose Rate Radiotherapy in Patients With Skin Metastases From Melanoma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Metastasis From Malignant Melanoma of Skin (Diagnosis)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2021-08-03
• Last updated: 2023-09-21

Locations

1 site across 1 country: Switzerland