Neoplasms

All Conditions

Carcinoma

Carcinoma, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

Dirk Schadendorf, Professor

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.

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

Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions

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

- type of tumor response as determined by the treating physician by clinical assessment and/or histological assessment and/or imaging assessment

- treatment decision for therapy with Vismodegib by tumor board OR by otorhinolaryngologist, surgeon, plastic surgeon, dermato-oncologist, radiotherapist, ophthalmologist

- previous treatment for the BCC lesion, which led to therapy with Vismodegib

- time to treatment interruptions of Vismodegib

- reason for treatment discontinuation of Vismodegib

The primary effectiveness measure for this study is as follows:

• To evaluate the duration of response, defined as duration from first documented complete response (CR) or first documented partial response (PR), whichever cam first, until disease progression (as determined by the treating physician), or death of any reason or up to 3 years from first dose Vismodegib, whichever occurs first, for laBCC patients.

number of patients with complete response or partial response as determined by the treating physician by clinical assessment, histological assessment, imaging assessment

time from first dose Vismodegib to complete response or partial response up to 3 years

number of complete response, partial response, stable disease

number of patients who responded (partial or complete) and later progressed

time from first dose Vismodegib to progression up to 3 years

time from first dose Vismodegib to death of any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions	NCT02781389	Basal Cell Carc...		18 Years -	University Hospital, Essen
Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions	NCT02781389	Basal Cell Carc...		18 Years -	University Hospital, Essen

Spots Global Cancer Trial Database for advanced bcc (abcc)