Image

Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma

Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma

Recruiting
18 years and older
All
Phase 2

Powered by AI

Overview

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.

Eligibility

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study details
    Basal Cell Carcinoma
    Radiotherapy; Complications

NCT05561634

University Hospital, Lille

15 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.