FLASH Radiotherapy for Skin Cancer

Launched by CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS · Feb 2, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of treatment called FLASH radiotherapy for patients with skin cancers, specifically Cutaneous Squamous Cell Carcinoma (cSCC) and Basal Cell Carcinoma (BCC). FLASH therapy uses a high dose of radiation given very quickly, and the study aims to see how it compares to the standard radiotherapy treatment that is commonly used. Researchers want to understand how effective it is and what side effects it may cause.

To be eligible for this trial, participants must be 60 years or older and have a confirmed diagnosis of cSCC or BCC. They should also need radiotherapy because surgery is not an option for them. Participants will be monitored closely throughout the study and may receive either the FLASH therapy or the standard treatment. It’s important to note that certain conditions, such as previous radiation treatment in the same area or other serious health issues, might exclude someone from participating. Overall, this trial offers a chance to explore a new treatment method for patients who need radiotherapy for their skin cancer.

Gender

ALL

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)