TerminatedPhase 2

To Assess The Efficacy And Safety Of Vismodegib And Radiotherapy In Advanced Basal Cell Carcinoma

Stopped: low recruitment rate

Italy14 participantsStarted 2016-10

Plain-language summary

This is a Fleming-A' Hern, single arm, multicenter, no-profit, phase II study of radiotherapy and Vismodegib in adult patients with high risk or locally advanced basal cell carcinoma not amenable to radical surgery cell carcinoma (BCC) (comparator: not applicable). The recruitment period is expected to be approximately 24 months. The trial will consist of a Screening/Baseline period (Day -28 to -1), a Treatment Period when patients will be treated with radiotherapy (4 weeks) followed by Vismodegib 150 mg/die continuously for six cycles (24 weeks). The study will end 14 months after start of treatment of the last patient enrolled and evaluable according to primary end point.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Written, signed informed consent
✓. Age ≥ 18 years
✓. Histopathologic confirmation that the lesion is BCC before enrollment
✓. Patients with high risk of relapse BCC not undergone radical surgery, for which treating physician must consider the disease to be no more operable.
✓. Clinical features defining high risk of relapse include infiltrative growth margins, size, tumor location, histological subtype (the morpheaform, the sclerosing, the infiltrating, the micronodular and the metatypical subtypes are associated with higher risk of relapse as compared to the risk associated with the superficial and the nodular types), recurrent-refractory tumors (see Table 1), basal cell carcinoma size (largest tumor diameter) ≤ 5 cm for head and neck tumors
✓. Clinical features for definition of "BCC not amenable for radical surgery" include:
✓. Patients with BCCs localized where surgery is technically difficult, or would result in unacceptable tissue destruction
✓. Patients with a clinical contraindication to surgery

Exclusion criteria

What they're measuring

evaluate the activity of the study therapy in terms of proportion of patients progression free

Timeframe: 1 years

Trial details

NCT IDNCT02956889

SponsorIstituto Clinico Humanitas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02

View on ClinicalTrials.gov More Carcinoma, Basal Cell trials