In this study patients with resectable basal cell carcinoma (BCC) who usually undergo surgery without prior anticancer treatment will be treated with antitumor medication. But since BCC is mainly localized in clearly visible regions of the body, as e.g. the face, there is also a need to reduce scars as a consequence of surgery which will be accomplished by neoadjuvant therapy. The used medication - vismodegib - displays controllable adverse events and shows a good efficacy for reduction of BCC lesions. It is expected that the neoadjuvant setting will lead to minor surgical intervention thus minimising surgical risks and scars for the patients.
Patients with resectable BCC will receive neoadjuvant vismodegib therapy for a time period of 12 weeks which applies to the routine use of vismodegib. This period is chosen because within this time side effects are acceptable and response is expected. Tumor examination will be performed monthly to expeditiously identify patients with progressive disease. This will be done by non-invasive imaging techniques thus a further objective of this study is the testing of diagnostic suitability of non-invasive methodology for the evaluation of response status of the patients. Patients in this clinical trial will be treated with an effective medication which is approved for the therapy of metastatic and locally advanced BCC for a time having been shown to be effective in neoadjuvant setting The same dose as approved for the advanced BCC disease is used, therefore it can be expected that the side effects will be predictable. Furthermore there are no hints in literature that the efficacy of the used medication may be decreased in patients with resectable BCC. Since the study patients are less sick than those for whom treatment with vismodegib is approved, surgery would be their therapy according to guideline. Thus the risk of vismodegib treatment has to be judged against the greater surgical risk if BCC will be operated directly without prior reduction of tumor lesion. A benefit for the great majority of the patients will be that smaller lesions result in minor scars and better cosmetically outcome of surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
1 capsule (150 mg vismodegib) taken once daily for a maximum of 12 weeks.
SRH Wald-Klinikum Gera GmbH
Gera, Thuringia, Germany
Klinikum Augsburg Süd
Augsburg, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Elbe Kliniken Stade - Buxtehude GmbH
Buxtehude, Germany
Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden
Dresden, Germany
HELIOS Klinikum Erfurt
Erfurt, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Universitätsklinikum Münster
Münster, Germany
Fachklinik Hornheide
Münster, Germany
Klinikum Nürnberg Nord
Nuremberg, Germany
...and 2 more locations
Disease control rate (DCR) defined as complete response (CR), partial response (PR), or stable disease (SD) after 12 weeks of treatment with vismodegib
Rate of patients with CR, PR and SD
Time frame: 12 weeks
Objective and relative (%) reduction of the involved skin surface after 12 weeks of treatment with vismodegib
Percent change of the BCC area from baseline to end of study therapy
Time frame: 12 weeks
DCR (CR, PR, or SD) after 12 weeks of treatment with vismodegib in the neoadjuvant treatment setting for different basal cell carcinoma histotypes (superficial, scleroderma, nodular, others)
Time frame: 12 weeks
Duration of overall response (DoR)
Time from documented CR, PR or SD until progression of disease
Time frame: 12 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 12 months
Health-related quality of life in patients receiving vismodegib for neoadjuvant treatment of basal cell carcinoma as measured by the Skindex-16 questionnaire
Time frame: 12 months
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