Basal Cell CarcinomaPhase 2RADIOSONICNCT05561634
Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma
A Phase 2 study testing Radiotherapy, Observation and Vismodegib in people with Basal Cell Carcinoma and Radiotherapy; Complications, run by University Hospital, Lille at 1 site in France.
Trial summary
Locally advanced basal cell carcinoma (BCC) are large BCCs or BCCs located in areas subject to functional and aesthetic risk following surgery or radiotherapy. In these particular situations, surgery and radiotherapy are sometimes not appropriate, and Sonic Hedgehog inhibitors (SHHi) (Vismodegib and Sonidegib) can be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma, Radiotherapy; Complications
- What is being tested?
- Radiotherapy, Observation and Vismodegib
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2023to 20 Jun 2029
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years
- Locally advanced non-recurrent BCC in complete response after first course of SHHi
- Complete response has to be confirmed histologically
- Available photography or CT scan before SHHi treatment allowing delineation of the initial tumor
Who cannot join
- Patients with distant metastasis
- Patients with Gorlin's syndrome
- Prior radiotherapy to the region of the studied cancer that would result in overlap of radiation therapy fields
- Pregnant women
- Life expectancy less than 1 year
- Inability to receive informed consent
Show all 9Show fewer
- Inability to participate in the entire study
- Lack of social security coverage
- Refusal to sign consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Lille
Lille
Laurent MORTIER, Pr, 0320444237, laurent.mortier@chu-lille.fr
About this study
Official title: Evaluation of Radiotherapy After Complete Response to Sonic Hedgehog Pathway Inhibitors in Patients With Locally Advanced Basal Cell Carcinoma: a Prospective Multicenter Study
Locally advanced basal cell carcinoma (BCC) are large BCCs or BCCs located in areas subject to functional and aesthetic risk following surgery or radiotherapy. In these particular situations, surgery and radiotherapy are sometimes not appropriate, and Sonic Hedgehog inhibitors (SHHi) (Vismodegib and Sonidegib) can be proposed. SHHi are effective treatments in laBCC but most CR patients discontinue treatment because of tolerability. Approximately 65% of the population experience a relapse after discontinuation. A few cases of patients treated concomitantly by radiotherapy and vismodegib have been reported in the literature, suggesting that combining vismodegib and concomitant radiotherapy results in an improved overall response compared to a single modality treatment. There is no study evaluating a "consolidation radiotherapy" after complete response to SHHi. We carry out a prospective multicenter study in order to evaluate consolidation radiotherapy in patients with laBCC after achieving complete response with SHHi, with the hypothesis of reducing recurrence after discontinuation of SHHi.
- Conditions
- Basal Cell Carcinoma, Radiotherapy; Complications
- Being tested
- Radiotherapy, Observation, Vismodegib
- Keywords
- Locally advanced basal cell carcinoma, Sonic Hedgehog inhibitors, Consideration 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.
RadiotherapyRadiation
Irradiation of the tumoral bed.
ObservationOther
Patients will be followed up in consultation every 3 months.
VismodegibDrug
Sonic Hedgehog inhibitors (SHHi) = Vismodegib et Sonidegib,
| Study group | Role | What they receive |
|---|---|---|
| SHHI then follow-up | Sham comparator | Not described Receives: Radiation: Radiotherapy; Other: Observation |
| SHHI then radiotherapy | Experimental | Not described Receives: Radiation: Radiotherapy; Drug: Vismodegib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a local relapse at 2 years in both groups.
Measured: At 2 years
Secondary outcomes (2)
Occurrence of local relapse at 1 and 3 years.
Measured: at 1 year and at 3 years
Occurrence of adverse effects in the radiotherapy group.
Measured: at 1 year, at 2 years and at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start20 Jun 2023
- Primary completion20 Jun 2029 (estimated)
- Study completion20 Jun 2029 (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 University Hospital, LilleThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Pharmaceutical Industries Limited
- Responsible party
- Sponsor
- Investigators
- Laurent Mortier, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561634
- Sponsor's protocol ID
- 2021_0710
- Other IDs
- 2022-A01424-39
- Acronym
- RADIOSONIC
- Status last verified
- Sep 2025
- First submitted
- 27 Sep 2022
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Radiotherapy After Complete Response to Sonic Hedgehog Pathway Inhibitors in Patients With Locally Advanced Basal Cell Carcinoma: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT05561634
- Acronym / sponsor ID
- RADIOSONIC / 2021_0710
- Conditions
- Basal Cell Carcinoma, Radiotherapy; Complications
- Keywords
- Locally advanced basal cell carcinoma, Sonic Hedgehog inhibitors, Consideration radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Sun Pharmaceutical Industries Limited
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 20 Jun 2029 (estimated)
- Study completion
- 20 Jun 2029 (estimated)
- First posted
- 30 Sep 2022 (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.
Locally advanced basal cell carcinoma (BCC) are large BCCs or BCCs located in areas subject to functional and aesthetic risk following surgery or radiotherapy. In these particular situations, surgery and radiotherapy are sometimes not appropriate, and Sonic Hedgehog inhibitors (SHHi) (Vismodegib and Sonidegib) can be proposed. SHHi are effective treatments in laBCC but most CR patients discontinue treatment because of tolerability. Approximately 65% of the population experience a relapse after discontinuation. A few cases of patients treated concomitantly by radiotherapy and vismodegib have been reported in the literature, suggesting that combining vismodegib and concomitant radiotherapy results in an improved overall response compared to a single modality treatment. There is no study evaluating a "consolidation radiotherapy" after complete response to SHHi. We carry out a prospective multicenter study in order to evaluate consolidation radiotherapy in patients with laBCC after achieving complete response with SHHi, with the hypothesis of reducing recurrence after discontinuation of SHHi.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHHI then follow-up | Sham comparator | Radiation: Radiotherapy, Other: Observation |
| SHHI then radiotherapy | Experimental | Radiation: Radiotherapy, Drug: Vismodegib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient over 18 years
- Locally advanced non-recurrent BCC in complete response after first course of SHHi
- Complete response has to be confirmed histologically
- Available photography or CT scan before SHHi treatment allowing delineation of the initial tumor
Key exclusion criteria (9 listed)
- Patients with distant metastasis
- Patients with Gorlin's syndrome
- Prior radiotherapy to the region of the studied cancer that would result in overlap of radiation therapy fields
- Pregnant women
- Life expectancy less than 1 year
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 |
|---|---|---|
| RadiotherapyIrradiation of the tumoral bed. | Radiation | SHHI then follow-up, SHHI then radiotherapy |
| ObservationPatients will be followed up in consultation every 3 months. | Other | SHHI then follow-up |
| VismodegibSonic Hedgehog inhibitors (SHHi) = Vismodegib et Sonidegib, | Drug | SHHI then radiotherapy |
Primary outcome
Occurrence of a local relapse at 2 years in both groups.
Time frame: At 2 years
2 secondary outcomes
Occurrence of local relapse at 1 and 3 years.
Time frame: at 1 year and at 3 years
Occurrence of adverse effects in the radiotherapy group.
Time frame: at 1 year, at 2 years and at 3 years
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 30 Sep 2025.
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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.
Laurent Mortier, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiotherapy, Observation and Vismodegib in people with Basal Cell Carcinoma and Radiotherapy; Complications, run by University Hospital, Lille at 1 site in France.
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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 30 Sep 2025. 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 France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Laurent Mortier, MD,PhD (0320445962, laurent.mortier@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of a local relapse at 2 years in both groups. (time frame: At 2 years). 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 30 Sep 2025.