Cutaneous Squamous Cell Carcinoma (CSCC)Phase 2LANCENCT07455331
Flash Radiotherapy for Skin Cancer
A Phase 2 study testing FLASH radiotherapy and Conventional radiotherapy in people with Cutaneous Squamous Cell Carcinoma (CSCC) and Basal Cell Carcinoma (BCC), run by Jules Bordet Institute at 1 site in Belgium.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma (CSCC), Basal Cell Carcinoma (BCC)
- What is being tested?
- FLASH radiotherapy and Conventional radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Jun 2026to 23 Dec 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed study Informed Consent Form
- Karnofsky Performance Status (KPS) ≥ 60
- Age ≥ 60 years
- Participants with histologically proven cSCC; or participants with BCC either histologically proven or proven by non-invasive imaging: either OCT, LC-OCT or RCM
- 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.
- T1-N0 lesions (TNM 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
- 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.
Who cannot join
- Previous radiotherapy in the treated area or a history of radiation therapy within 4 cm of the lesion to be treated
- 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 EOT visit)
- Concomitant use of systemic or immunochemotherapy for skin cancer(s)
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- Concomitant use of systemic chemotherapy for a cancer other than the skin cancer(s)
- Topical antitumoral treatment is prohibited within the radiation field except after a mandatory 4-weeks washout period.
- Any active cutaneous infection within the irradiation field (except if completely resolved prior to the initiation of radiotherapy).
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
- Being tested
- FLASH radiotherapy, Conventional radiotherapy
- Keywords
- radiotherapy, FLASH, skin cancer
- Medical subject headings
- Carcinoma, Basal Cell, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLASH radiotherapyRadiation
FLASH therapy is delivered almost instantaneously (in milliseconds), as opposed to conventional radiotherapy, which is delivering the dose in minutes.
Conventional radiotherapyRadiation
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| FLASH radiotherapy | Experimental | 22 Gy single dose FLASH radiotherapy Receives: Radiation: FLASH radiotherapy |
| Conventional radiotherapy | Active comparator | 22 Gy single dose conventional radiotherapy Receives: Radiation: Conventional radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of FLASH 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).
Measured: "From enrollment until 6 weeks after radiotherapy"
hierarchically tested efficacy of FLASH radiotherapy
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.
Measured: "From enrollment until 1-year post randomization"
Secondary outcomes (3)
Evaluate tumor response
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
Measured: "From enrolment until 12 months post-treatment"
Evaluate acute side effects "in the radiation field"
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.
Measured: "From enrollment until 6 weeks after the irradiation date"
Evaluate late side effects "in the radiation field"
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.
Measured: "From 3 months post treatment until 12 months post treatment"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start23 Jun 2026 (estimated)
- Primary completion23 Dec 2029 (estimated)
- Study completion23 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Squamous Cell Carcinoma (CSCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455331
- Sponsor's protocol ID
- IJB-LANCE-2025
- Acronym
- LANCE
- Status last verified
- Mar 2026
- First submitted
- 28 Nov 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided