NCT07455331

Flash Radiotherapy for Skin Cancer

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical investigation is to describe and compare the toxicity and efficacy of an experimental radiotherapy, named FLASH therapy, to conventional radiotherapy for subjects suffering from localized Cutaneous Squamous Cell Carcinoma (cSCC) and Basal Cell Carcinoma (BCC). FLASH therapy can deliver the irradiation dose within milliseconds instead of the minutes commonly required in conventional radiotherapy, with the aim of providing a curative dose while minimizing side effects on healthy tissue. This is a phase II selection and monocentric clinical investigation with a 1 to 1 randomization. This clinical investigation will include approximately 60 participants aged ≥ 60 years old with one or more localized cSCC and BCC who either cannot undergo surgery or decline surgical resection. The study design is the following: * On day 1, either a single dose FLASH radiotherapy (22 Gy) will be delivered or a single dose conventional radiotherapy (22 Gy) will be delivered to the selected localized cSCC or BCC lesion(s) (up to maximum 3 per participant; all lesions distant of at least 4 cm from one-another). * The surveillance period will be of 6 weeks post irradiation. * Follow-up visits will take place at 3, 6, and 12 months post-treatment.

Conditions

• Cutaneous Squamous Cell Carcinoma (CSCC)
• Basal Cell Carcinoma (BCC)

Interventions

Type	Name	Description
RADIATION	FLASH radiotherapy	FLASH therapy is delivered almost instantaneously (in milliseconds), as opposed to conventional radiotherapy, which is delivering the dose in minutes.
RADIATION	Conventional radiotherapy	Standard of Care

Timeline

• Start date: 2026-03-23
• Primary completion: 2029-12-23
• Completion: 2030-12-23
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

1 site across 1 country: Belgium