Flash Radiotherapy for Skin Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorJules Bordet Institute

About this trial

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.

Eligibility criteria

Qualifiers

Signed study Informed Consent Form

Karnofsky Performance Status (KPS) ≥ 60

Age ≥ 60 years

Participants with histologically proven cSCC; or participants with BCC either histologically proven or proven by non-invasive imaging: either OCT, LC-OCT or RCM

Disqualifiers

Previous radiotherapy in the treated area or a history of radiation therapy within 4 cm of the lesion to be treated

Concomitant auto-immune disease with skin lesions

Concomitant use of radio-sensitizer drug

Cognitive disorders not compatible with the signature of informed consent or that may compromise compliance with the requirements of the study

Trial design

Treatments tested in this trial

  • FLASH radiotherapy
  • Conventional radiotherapy

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators