FLASH Radiotherapy for Skin Cancer

NCT05724875 | Active Not Recruiting DMC

• 1 other identifier: CHUV-DO-0024-LANCE-2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Basal Cell Carcinoma; Cutaneous Squamous Cell Carcinoma

Keywords

FLASH therapy; basal cell carcinoma; cutaneous squamous cell carcinoma; high dose rate radiotherapy

Outcome Measures

Primary Outcomes (2)

• Frequency of ≥ grade 3 skin toxicity adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

  To evaluate the safety of FLASH radiotherapy measured by the collection of ≥ grade 3 skin toxicity AEs according to CTCAE version 5.0. The severity of a specific event is graded i.e. mild (grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4), or death (grade 5) using the CTCAE Grading Table.

  up to 6 weeks after radiotherapy

• Hierarchically tested efficacy measured by local control rate

  At day 1, 21, 28, 42, and months 3, 6, and 12 post-treatment, the investigator will measure (with a caliper) the largest diameter of selected lesions for irradiation. Tumor response of each irradiated lesion will be assessed by the investigator as follow: * Complete Response: the irradiated lesion is no more visualized * Partial Response: the irradiated largest lesion dimension decreased by 30% at least from baseline (day 1) * Progressive Disease: the irradiated largest lesion dimension increased by 20% at least from baseline (day 1) * Stable Disease: no Complete Response, no Partial Response, no Progressive Disease

  From Day 1 up to 12 months post-treatment

Secondary Outcomes (11)

• Frequency of acute side effects observed "in radiation field"

  up to 3 months after radiotherapy

• Frequency of late side effects observed "in radiation field"

  from ≥ 3 months after radiotherapy until 12 months post-treatment start

• Evaluation of tumor response

  From Day 1 up to 12 months post-treatment

• Evaluation of "in radiation field" normal tissues reaction around the treated tumors

  From Day 1 up to 12 months post-treatment

• Epidermis thickness measured by Optical coherence tomography (OCT)

  at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment

Study Arms (2)

Arm A: FLASH RT

EXPERIMENTAL

Device: FLASH RT

Arm B: Conventional RT

ACTIVE COMPARATOR

Device: Conventional RT

Interventions

FLASH RT DEVICE

For T1 (small) lesions: 22 Gy single dose FLASH RT; For T2 (large) lesions: 5 x 6 Gy fractionated dose FLASH RT

Also known as: High dose rate radiotherapy

Arm A: FLASH RT

Conventional RT DEVICE

For T1 (small) lesions: 22 Gy single dose conventional RT; For T2 (large) lesions: 5 x 6 Gy fractionated dose conventional RT

Arm B: Conventional RT

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Officials

• Olivier Gaide, MD, PhD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

• Jean Bourhis, MD, PhD

  Centre Hospitalier Universitaire Vaudois

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof, MD, PhD

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 13, 2023
• Study Start: June 22, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CH (1)