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NCT Number: NCT05561634

Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma

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.

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Radiotherapy; Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy

Radiation

Irradiation of the tumoral bed.

observation

Other

Patients will be followed up in consultation every 3 months.

vismodegib

Drug

Sonic Hedgehog inhibitors (SHHi) = Vismodegib et Sonidegib,

Primary outcomes

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

    Time frame: At 2 years

Secondary outcomes

  1. Occurrence of local relapse at 1 and 3 years.

    Time frame: at 1 year and at 3 years

  2. Occurrence of adverse effects in the radiotherapy group.

    Time frame: at 1 year, at 2 years and at 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Laurent Mortier, MD,PhD

CONTACT

[email protected]

0320445962

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Sun Pharmaceutical Industries Limited

Registry information

Official study title

Evaluation of Radiotherapy After Complete Response to Sonic Hedgehog Pathway Inhibitors in Patients With Locally Advanced Basal Cell Carcinoma: a Prospective Multicenter Study

Acronym: RADIOSONIC

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Sep 30, 2022
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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