FLASH Radiotherapy for Skin Cancer (LANCE)

Vaud University Hospital Center

Status

Enrolling

Conditions

Cutaneous Squamous Cell Carcinoma

Basal Cell Carcinoma

Treatments

Device: FLASH RT

Device: Conventional RT

Study type

Interventional

Funder types

Other

Identifiers

NCT05724875

CHUV-DO-0024-LANCE-2020

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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)