Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiotherapy

    Radiation

    Irradiation of the tumoral bed.

  • Observation

    Other intervention

    Patients will be followed up in consultation every 3 months.

  • Vismodegib

    Drug

    Sonic Hedgehog inhibitors (SHHi) = Vismodegib et Sonidegib,

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: SHHI then follow-upSham comparator 2 interventions
Group B: SHHI then radiotherapyExperimental treatment 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

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University Hospital, Lille

Lead sponsor

Sun Pharmaceutical Industries Limited

Collaborator