NCT05561634

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for phase_2

Timeline
38mo left

Started Jun 2023

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Jun 2023Jun 2029

First Submitted

Initial submission to the registry

September 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

June 20, 2023

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2029

Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

6 years

First QC Date

September 27, 2022

Last Update Submit

September 24, 2025

Conditions

Basal Cell CarcinomaRadiotherapy; Complications

Keywords

Locally advanced basal cell carcinomaSonic Hedgehog inhibitorsConsideration radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Occurrence of a local relapse at 2 years in both groups.

    At 2 years

Secondary Outcomes (2)

  • Occurrence of local relapse at 1 and 3 years.

    at 1 year and at 3 years

  • Occurrence of adverse effects in the radiotherapy group.

    at 1 year, at 2 years and at 3 years

Study Arms (2)

SHHI then follow-up

SHAM COMPARATOR
Radiation: RadiotherapyOther: Observation

SHHI then radiotherapy

EXPERIMENTAL
Radiation: RadiotherapyDrug: Vismodegib

Interventions

RadiotherapyRADIATION

Irradiation of the tumoral bed.

SHHI then follow-upSHHI then radiotherapy
ObservationOTHER

Patients will be followed up in consultation every 3 months.

SHHI then follow-up
VismodegibDRUG

Sonic Hedgehog inhibitors (SHHi) = Vismodegib et Sonidegib,

SHHI then radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Inability to participate in the entire study
  • Lack of social security coverage
  • Refusal to sign consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Lille

Lille, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

RadiotherapyObservationHhAntag691

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

TherapeuticsMethodsInvestigative Techniques

Study Officials

  • Laurent Mortier, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent Mortier, MD,PhD

CONTACT

0320445962laurent.mortier@chru-lille.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2022

First Posted

September 30, 2022

Study Start

June 20, 2023

Primary Completion (Estimated)

June 20, 2029

Study Completion (Estimated)

June 20, 2029

Last Updated

September 30, 2025

Record last verified: 2025-09

Locations

FR(1)