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.
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. The primary objective is to evaluate the activity of the study therapy (radiotherapy followed by six cycles of Vismodegib 150 mg/d continuously) in terms of proportion of patients progression free at 12 months. The secondary objectives are: to evaluate the efficacy of the study therapy in terms of progression free survival (PFS) and overall survival (OS); to assess the response in terms of overall response rate (ORR) (complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)); to assess duration of response (DoR); to assess the safety in terms of incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs) ;to measure the effects of skin disease on quality of life (QoL) of patients under therapy (Skindex-16)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Patients will receive a continuous once-daily oral dosing of Vismodegib at a dosage of 150 mg .
Radiotherapy (RT) will be administered with a total dose of 50 Gy/2.5 Gy per fraction over 4 weeks.
Istituto Clinico humanitas
Rozzano, Mi, Italy
evaluate the activity of the study therapy in terms of proportion of patients progression free
The primary objective is to evaluate the activity of the study therapy (radiotherapy followed by six cycles of Vismodegib 150 mg/d continuously) in terms of proportion of patients progression free at 12 months.
Time frame: 1 years
evaluate the efficacy of the study therapy in terms of progression free survival
The secondary objectives are: to evaluate the efficacy of the study therapy in terms of progression free survival (PFS)
Time frame: 2 years
evaluate the efficacy of the study therapy in terms overall survival
The secondary objectives are: to evaluate the efficacy of the study therapy in terms of overall survival (OS);
Time frame: 2 years
response in terms of overall response rate (ORR)
to assess the response in terms of ORR (complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD))
Time frame: 2 years
duration of response
to assess duration of response (DoR);
Time frame: 2 years
assess the safety in terms of incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs)
to assess the safety in terms of incidence, type, and severity of AEs and SAEs
Time frame: 2 years
measure the effects of skin disease on quality of life (QoL) of patients
to measure the effects of skin disease on quality of life (QoL) of patients under therapy (Skindex-16)
Time frame: 2 years
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