Clinical trial NCT05724875: FLASH Radiotherapy for Skin Cancer
Official title: Randomized Phase II Selection Trial of FLASH Versus Conventional Radiotherapy for Patients with Localized Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Basal Cell Carcinoma
Cutaneous Squamous Cell Carcinoma
Keywords: FLASH therapy
basal cell carcinoma
cutaneous squamous cell carcinoma
high dose rate radiotherapy
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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)

Primary outcomes:
measure: Frequency of ≥ grade 3 skin toxicity adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
timeFrame: up to 6 weeks after radiotherapy
measure: Hierarchically tested efficacy measured by local control rate
timeFrame: From Day 1 up to 12 months post-treatment
Secondary outcomes:
measure: Frequency of acute side effects observed "in radiation field"
timeFrame: up to 3 months after radiotherapy
measure: Frequency of late side effects observed "in radiation field"
timeFrame: from ≥ 3 months after radiotherapy until 12 months post-treatment start
measure: Evaluation of tumor response
timeFrame: From Day 1 up to 12 months post-treatment
measure: Evaluation of "in radiation field" normal tissues reaction around the treated tumors
timeFrame: From Day 1 up to 12 months post-treatment
measure: Epidermis thickness measured by Optical coherence tomography (OCT)
timeFrame: at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment
measure: Epidermis roughness measured by OCT
timeFrame: at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment
measure: Plexus depth measured by OCT
timeFrame: at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment
measure: Vessel density measured by OCT
timeFrame: at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment
measure: Size of vessels measured by OCT
timeFrame: at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment
measure: Number of hairs counted by OCT
timeFrame: at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment
measure: Size of hairs measured by OCT
timeFrame: at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Olivier Gaide, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire Vaudois
name: Jean Bourhis, MD, PhD
role: STUDY_CHAIR
References: