Flash Radiotherapy for Skin Cancer (LANCE)

May 6, 2026 updated by: Jules Bordet Institute

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

The goal of this clinical investigation is to describe and compare the toxicity and efficacy of an experimental radiotherapy, named FLASH therapy, to conventional radiotherapy for subjects suffering from localized Cutaneous Squamous Cell Carcinoma (cSCC) and Basal Cell Carcinoma (BCC). FLASH therapy can deliver the irradiation dose within milliseconds instead of the minutes commonly required in conventional radiotherapy, with the aim of providing a curative dose while minimizing side effects on healthy tissue.

This is a phase II selection and monocentric clinical investigation with a 1 to 1 randomization. This clinical investigation will include approximately 60 participants aged ≥ 60 years old with one or more localized cSCC and BCC who either cannot undergo surgery or decline surgical resection.

The study design is the following:

  • On day 1, either a single dose FLASH radiotherapy (22 Gy) will be delivered or a single dose conventional radiotherapy (22 Gy) will be delivered to the selected localized cSCC or BCC lesion(s) (up to maximum 3 per participant; all lesions distant of at least 4 cm from one-another).
  • The surveillance period will be of 6 weeks post irradiation.
  • Follow-up visits will take place at 3, 6, and 12 months post-treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Anderlecht
      • Brussels, Anderlecht, Belgium, 1070
        • Institut Jules Bordet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signed study Informed Consent Form
  2. Karnofsky Performance Status (KPS) ≥ 60
  3. Age ≥ 60 years
  4. Participants with histologically proven cSCC; or participants with BCC either histologically proven or proven by non-invasive imaging: either OCT, LC-OCT or RCM
  5. Participants requiring radiotherapy treatment according to the dermato-oncology tumor board: participants who cannot undergo surgical procedure or participants who decline surgical resection, and/or anatomical locations where surgery can compromise function or cosmesis.
  6. T1-N0 lesions (TNM UICC, 8th Edition)
  7. 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
  8. In cases of prior intervention within the target area, the treated lesion must be located at a distance of > 4 cm from the previous site.

Exclusion Criteria:

  1. Previous radiotherapy in the treated area or a history of radiation therapy within 4 cm of the lesion to be treated
  2. Concomitant auto-immune disease with skin lesions
  3. Concomitant use of radio-sensitizer drug
  4. Cognitive disorders not compatible with the signature of informed consent or that may compromise compliance with the requirements of the study
  5. Current, recent (within 10 days prior to start of study treatment), or planned participation in an experimental drug study (before EOT visit)
  6. Concomitant use of systemic or immunochemotherapy for skin cancer(s)
  7. Concomitant use of systemic chemotherapy for a cancer other than the skin cancer(s)
  8. Topical antitumoral treatment is prohibited within the radiation field except after a mandatory 4-weeks washout period.
  9. Any active cutaneous infection within the irradiation field (except if completely resolved prior to the initiation of radiotherapy).
  10. Uncontrolled intercurrent comorbidities that may impair wound healing including Diabetes Mellitus (HbA1c > 8.5% or evidence of active diabetic ulceration), Chronic Venous Insufficiency with active venous ulcers, or severe (Grade 3+) oedema in the treatment field.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FLASH radiotherapy
22 Gy single dose FLASH radiotherapy
Radiation: FLASH radiotherapy
FLASH therapy is delivered almost instantaneously (in milliseconds), as opposed to conventional radiotherapy, which is delivering the dose in minutes.
Active Comparator: Conventional radiotherapy
22 Gy single dose conventional radiotherapy
Radiation: Conventional radiotherapy
Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the safety of FLASH radiotherapy
Time Frame: "From enrollment until 6 weeks after radiotherapy"
Safety of FLASH radiotherapy measured by the collection of ≥ grade 3 skin toxicity AEs (CTCAE v6.0) ≤ 6 weeks after radiotherapy. Assessment will be performed by physical examination at 3,4,6 weeks post treatment (It may be necessary to perform these procedures at unscheduled time points if deemed clinically necessary by the investigator).
"From enrollment until 6 weeks after radiotherapy"
hierarchically tested efficacy of FLASH radiotherapy
Time Frame: "From enrollment until 1-year post randomization"
Hierarchically tested efficacy measured by local control rate at 1-year. Local control rate is censured by any in field local relapse up to one-year post randomization (Tumor response evaluated during physical exam). Assessment will be performed by physical exam and Blinded Imaging Central Review (BICR) of photographs at 3,4,6 weeks and 3,6,12 months.
"From enrollment until 1-year post randomization"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate tumor response
Time Frame: "From enrolment until 12 months post-treatment"
Tumor response Assessment will be performed by physical exam and Blinded Imaging Central Review (BICR) of photographs at 3,4,6 weeks and 3,6,12 months post treatment
"From enrolment until 12 months post-treatment"
Evaluate acute side effects "in the radiation field"
Time Frame: "From enrollment until 6 weeks after the irradiation date"
Acute side effects "in the radiation field" defined by any toxicity (CTCAE v6.0), until 3 months after the irradiation date. Assessment will be performed by physical exam, Blinded Imaging Central Review (BICR) of photographs at 3,4,6 weeks post treatment and OCT (optical coherence tomography) at 4 weeks post treatment.
"From enrollment until 6 weeks after the irradiation date"
Evaluate late side effects "in the radiation field"
Time Frame: "From 3 months post treatment until 12 months post treatment"
Late side effects "in the radiation field" (within 3 to 12 months post-treatment) (CTCAE v6.0). Assessment will be performed by physical exam, Blinded Imaging Central Review (BICR) of photographs 3,6,12 months post treatment and OCT (optical coherence tomography) at 6 and 12 months.
"From 3 months post treatment until 12 months post treatment"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jules Bordet Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 23, 2026

Primary Completion (Estimated)

December 23, 2029

Study Completion (Estimated)

December 23, 2030

Study Registration Dates

First Submitted

November 28, 2025

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IJB-LANCE-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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