Basal Cell CarcinomaLANCENCT05724875
FLASH Radiotherapy for Skin Cancer
A study testing FLASH RT and Conventional RT in people with Basal Cell Carcinoma and Cutaneous Squamous Cell Carcinoma, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Basal Cell Carcinoma, Cutaneous Squamous Cell Carcinoma
- What is being tested?
- FLASH RT and Conventional RT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Jun 2023to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011
About this study
Official title: Randomized Phase II Selection Trial of FLASH Versus Conventional Radiotherapy for Patients With Localized Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma
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.
- Being tested
- FLASH RT, Conventional RT
- Keywords
- FLASH therapy, basal cell carcinoma, cutaneous squamous cell carcinoma, high dose rate radiotherapy
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLASH RTDevice
Also called High dose rate radiotherapy
For T1 (small) lesions: 22 Gy single dose FLASH RT; For T2 (large) lesions: 5 x 6 Gy fractionated dose FLASH RT
Conventional RTDevice
For T1 (small) lesions: 22 Gy single dose conventional RT; For T2 (large) lesions: 5 x 6 Gy fractionated dose conventional RT
| Study group | Role | What they receive |
|---|---|---|
| Arm A: FLASH RT | Experimental | Not described Receives: Device: FLASH RT |
| Arm B: Conventional RT | Active comparator | Not described Receives: Device: Conventional RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From Day 1 up to 12 months post-treatment
Secondary outcomes (11)
Frequency of acute side effects observed "in radiation field"
Measured: up to 3 months after radiotherapy
Frequency of late side effects observed "in radiation field"
Measured: from ≥ 3 months after radiotherapy until 12 months post-treatment start
Evaluation of tumor response
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.
Measured: From Day 1 up to 12 months post-treatment
Evaluation of "in radiation field" normal tissues reaction around the treated tumors
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.
Measured: From Day 1 up to 12 months post-treatment
Epidermis thickness measured by Optical coherence tomography (OCT)
Epidermis thickness in micrometer will be measured by OCT and compared between irradiated skin and normal non-irradiated skin
Measured: at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment
Epidermis roughness measured by OCT
Epidermis roughness in micrometer will be measured by OCT and compared between irradiated skin and normal non-irradiated skin
Measured: at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment
Plexus depth measured by OCT
Plexus depth in micrometer will be measured by OCT and compared between irradiated skin and normal non-irradiated skin
Measured: at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment
Vessel density measured by OCT
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
Measured: at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment
Size of vessels measured by OCT
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
Measured: at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment
Number of hairs counted by OCT
Number of hairs in the examined area will be counted by OCT and compared between irradiated skin and normal non-irradiated skin
Measured: at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment
Size of hairs measured by OCT
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
Measured: at baseline, at 4 weeks, at 6 months, and at 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 posted13 Feb 2023
- Study start22 Jun 2023
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Olivier Gaide, MD-PhD, Centre Hospitalier Universitaire Vaudois
- Investigators
- Olivier Gaide, MD, PhD, Principal investigator, Centre Hospitalier Universitaire VaudoisJean Bourhis, MD, PhD, Study chair, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724875
- Sponsor's protocol ID
- CHUV-DO-0024-LANCE-2020
- Acronym
- LANCE
- Status last verified
- Mar 2026
- First submitted
- 17 Jan 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Selection Trial of FLASH Versus Conventional Radiotherapy for Patients With Localized Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05724875
- Acronym / sponsor ID
- LANCE / CHUV-DO-0024-LANCE-2020
- Keywords
- FLASH therapy, basal cell carcinoma, cutaneous squamous cell carcinoma, high dose rate radiotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: FLASH RT | Experimental | Device: FLASH RT |
| Arm B: Conventional RT | Active comparator | Device: Conventional RT |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLASH RTAlso: High dose rate radiotherapyFor T1 (small) lesions: 22 Gy single dose FLASH RT; For T2 (large) lesions: 5 x 6 Gy fractionated dose FLASH RT | Device | Arm A: FLASH RT |
| Conventional RTFor T1 (small) lesions: 22 Gy single dose conventional RT; For T2 (large) lesions: 5 x 6 Gy fractionated dose conventional RT | Device | Arm B: Conventional RT |
Primary outcome
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.
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
11 secondary outcomes
Frequency of acute side effects observed "in radiation field"
Time frame: up to 3 months after radiotherapy
Frequency of late side effects observed "in radiation field"
Time frame: from ≥ 3 months after radiotherapy until 12 months post-treatment start
Evaluation of tumor response
Time frame: From Day 1 up to 12 months post-treatment
Evaluation of "in radiation field" normal tissues reaction around the treated tumors
Time frame: From Day 1 up to 12 months post-treatment
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 roughness measured by OCT
Time frame: at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment
Plexus depth measured by OCT
Time frame: at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment
Vessel density measured by OCT
Time frame: at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment
Size of vessels measured by OCT
Time frame: at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment
Number of hairs counted by OCT
Time frame: at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment
Size of hairs measured by OCT
Time frame: at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Gaide, MD, PhD principal investigator
Centre Hospitalier Universitaire Vaudois
Jean Bourhis, MD, PhD study chair
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLASH RT and Conventional RT in people with Basal Cell Carcinoma and Cutaneous Squamous Cell Carcinoma, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026; AzTrials last refreshed its copy on 2 Nov 2026.