Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions — JONAS  

Basal Cell Carcinoma Clinical Trial

Official title: Non-interventional Study to Investigate the Effectiveness, Safety and Utilization of Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions

Status Completed

Clinical Trial Summary

The aim of this non-interventional study is to provide further data on the utilization, effectiveness, safety and clinical benefit including duration of response of Vismodegib for treatment of locally advanced basal cell carcinoma (laBCC), inappropriate for surgery or radiotherapy under real world clinical conditions.

Clinical Trial Description

This is a multi-center non-interventional study with 53 patients with locally advanced BCC who start Vismodegib (received at least one dose) in Q4 2015. Duration of recruitment will be one year. Patients will be followed prospectively until disease progression, death, or for 3 years from first dose Vismodegib (whichever occurs first).

The primary effectiveness objective for this study is as follows:

• To evaluate the duration of response defined as duration from first documented response of complete response (CR) or partial response (PR) until disease progression (as determined by the treating physician, which might include and will be categorized in the following groups: clinical assessment, histological assessment, imaging assessment) for laBCC patients.

The secondary effectiveness objectives for this study are as follows:

• Objective response rate (rate of patients with CR or PR) (as determined by the treating physician, which might include and will be categorized in the following groups: clinical assessment, histological assessment, imaging assessment)

• Disease control rate (complete response (CR), partial response (PR) or stable disease (SD))

• Recurrence rate: rate of patients who responded (CR or PR) and later progressed

• Time to progression: time from first treatment to progression

• Time to death: time from first treatment to death

• Time to response: time from first treatment to response

The explorative objectives of this study are to evaluate the following endpoints:

• Type of tumor response evaluation (as determined by the treating physician, which might include and will be categorized in the following groups: clinical assessment , histological assessment, imaging assessment)

• Treatment decision for therapy with Vismodegib (tumor board OR decision by otorhinolaryngologist, surgeon, plastic surgeon, dermato-oncologist, radiotherapist, ophthalmologist)

• Utilization

• Previous treatment for the BCC lesion, which led to therapy with Vismodegib

• BCC therapy after Vismodegib therapy (if applicable)

• Treatment duration of Vismodegib (start and stop dates for therapy with Vismodegib)

• Assessment of duration and time point of treatment interruptions of Vismodegib

• Reason for treatment discontinuation ;

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

• NCT number: NCT02781389
• Study type: Observational
• Source: University Hospital, Essen
• Status: Completed
• Start date: April 29, 2016
• Completion date: May 31, 2021