NCT05724875

FLASH Radiotherapy for Skin Cancer

Randomized Phase II Selection Trial of FLASH Versus Conventional Radiotherapy for Patients With Localized Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

This is a single center randomized selected Phase II study of FLASH radiotherapy (RT) versus standard of care (SOC) radiotherapy in patients with localized Cutaneous Squamous Cell Carcinoma (cSCC) or Basal Cell Carcinoma (BCC). In summary, the aims of the study are to describe and compare the toxicity and efficacy of high dose rate radiotherapy (FLASH therapy) to SOC conventional radiotherapy (according to the standard guidelines per lesion size) through a randomized Phase II selection study in patients presenting localized cSCC or BCC requiring a radiotherapy treatment.

Conditions

• Basal Cell Carcinoma
• Cutaneous Squamous Cell Carcinoma

Interventions

Type	Name	Description
DEVICE	FLASH RT	For T1 (small) lesions: 22 Gy single dose FLASH RT; For T2 (large) lesions: 5 x 6 Gy fractionated dose FLASH RT
DEVICE	Conventional RT	For T1 (small) lesions: 22 Gy single dose conventional RT; For T2 (large) lesions: 5 x 6 Gy fractionated dose conventional RT

Timeline

• Start date: 2023-06-22
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2023-02-13
• Last updated: 2026-03-27

Locations

1 site across 1 country: Switzerland