High dose FLASH radiotherapy for skin cancer treatment

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

This study tests if a new high dose FLASH radiotherapy can treat skin cancer better and with fewer side effects than the standard radiotherapy for patients who can't have surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire Vaudois (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Lausanne, Vaud)
• Trial ID: NCT05724875 on ClinicalTrials.gov

What this trial studies

This clinical trial compares the efficacy and toxicity of FLASH radiotherapy to standard of care radiotherapy in patients with localized Cutaneous Squamous Cell Carcinoma (cSCC) or Basal Cell Carcinoma (BCC). It is a single center randomized Phase II study that aims to evaluate the outcomes of high dose rate FLASH therapy against conventional radiotherapy. Eligible patients include those who cannot undergo surgery or have declined surgical options, and the study focuses on specific tumor sizes and locations. The trial will assess the effectiveness of these treatments in managing skin cancer.

Who should consider this trial

Good fit: Ideal candidates are patients aged 60 and older with localized cSCC or BCC requiring radiotherapy.

Not a fit: Patients with lesions located on the face or those who are not eligible for radiotherapy will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and less toxic treatment option for patients with skin cancer.

How similar studies have performed: Other studies have shown promising results with FLASH therapy, indicating potential for success in this novel approach.

Eligibility criteria

Inclusion Criteria:

* Signed study Informed Consent Form
* Karnofsky Performance Status (KPS) ≥ 60
* Age ≥ 60 years
* Patients with histologically proven cSCC or patients with BCC either histologically proven or proven by non-invasive imaging: either Optical Coherence Tomography (OCT), Line-field OCT (LC-OCT) or Reflectance Confocal Microscopy (RCM)
* Patients requiring radiotherapy treatment according to the dermato-oncology tumor board: patients who cannot undergo surgical procedure or patients who decline surgical resection, and/or anatomical locations where surgery can compromise function or cosmesis.
* T1-T2 N0 lesions with a small (T1; lesion ≤ 2cm in diameter) or large (T2; 2cm \< lesion ≤ 4 cm) volume (TNM Classification of Malignant Tumours (TNM) Union for International Cancer Control (UICC), 8th Edition)
* Lesions should be at least 4 cm apart if treated with 2 different modalities (including surgical treatment of lesions). Lesions should not be located on the face, except on the forehead, above a line situated 1 cm above the eyebrows. Lesions located on the scalp can be treated.

Exclusion Criteria:

* Previous radiotherapy in the treated area
* 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
* Current, recent (within 10 days prior to start of study treatment), or planned participation in an experimental drug study (before end of treatment (EOT) visit)
* Concomitant use of systemic chemotherapy for a cancer other than the skin cancer(s)

Where this trial is running

Lausanne, Vaud

• Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Vaud, Switzerland (RECRUITING)

Study contacts

• Principal investigator: Olivier Gaide, MD, PhD — Centre Hospitalier Universitaire Vaudois
• Study coordinator: Fernanda Herrera, MD, PhD

Conditions: Basal Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, FLASH therapy, basal cell carcinoma, cutaneous squamous cell carcinoma, high dose rate radiotherapy