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NCT Number: NCT05724875

FLASH Radiotherapy for Skin Cancer

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.

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Cutaneous Squamous Cell Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other names: High dose rate radiotherapy

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

Primary outcomes

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

    Time frame: up to 6 weeks after radiotherapy

    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.

  2. Hierarchically tested efficacy measured by local control rate

    Time frame: From Day 1 up to 12 months post-treatment

    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

Secondary outcomes

  1. Frequency of acute side effects observed "in radiation field"

    Time frame: up to 3 months after radiotherapy

  2. Frequency of late side effects observed "in radiation field"

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

  3. Evaluation of tumor response

    Time frame: From Day 1 up to 12 months post-treatment

    Blinded Imaging Central Review (BICR) of photographs will evaluate tumor response by grading the size of the residual tumor in comparison to the size of the tumor on the day of irradiation (in percentage). 0% means no residual tumor and treatment success, 100% or more indicate a total lack of tumor response.

    A baseline photograph will be taken the day of the treatment (day 1) in a pre-therapeutic setting with skin delineation of the lesion. Then photos will be repeated at day 21 (+/-2d), day 28 (+/-2d), day 42 (+/-3d) after treatment, then at 3 (+/-7d), 6 (+/-14d), 12 (+/-14d) months after treatment, and at progression.

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

    Time frame: From Day 1 up to 12 months post-treatment

    Blinded Imaging Central Review (BICR) of photographs will evaluate "in radiation field" normal tissues reaction around the treated tumors by grading radiation induced skin reactions, grade 1-5, using the CTCAE scale.

    A baseline photograph will be taken the day of the treatment (day 1) in a pre-therapeutic setting with skin delineation of the lesion. Then photos will be repeated at day 21 (+/-2d), day 28 (+/-2d), day 42 (+/-3d) after treatment, then at 3 (+/-7d), 6 (+/-14d), 12 (+/-14d) months after treatment, and at progression.

  5. Epidermis thickness measured by Optical coherence tomography (OCT)

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

    Epidermis thickness in micrometer will be measured by OCT and compared between irradiated skin and normal non-irradiated skin

  6. Epidermis roughness measured by OCT

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

    Epidermis roughness in micrometer will be measured by OCT and compared between irradiated skin and normal non-irradiated skin

  7. Plexus depth measured by OCT

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

    Plexus depth in micrometer will be measured by OCT and compared between irradiated skin and normal non-irradiated skin

  8. Vessel density measured by OCT

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

    Vessel density, expressed as percent of the surface covered by the vessels in the examined area, will be measured by OCT and compared between irradiated skin and normal non-irradiated skin

  9. Size of vessels measured by OCT

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

    Mean size (in micrometer) of all vessels in the examined area will be measured by OCT and compared between irradiated skin and normal non-irradiated skin

  10. Number of hairs counted by OCT

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

    Number of hairs in the examined area will be counted by OCT and compared between irradiated skin and normal non-irradiated skin

  11. Size of hairs measured by OCT

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

    Mean size (in micrometer) of all hairs in the examined area will be measured by OCT and compared between irradiated skin and normal non-irradiated skin

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

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

Acronym: LANCE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2023
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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