Ignite Creation Date:
2024-05-06 @ 9:38 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03035188
Status:
COMPLETED
Last Update Posted:
2022-02-11
First Post:
2016-12-26
Brief Title:
Neoadjuvant Vismodegib in Patients With Large andor Recurrent Resectable Basal Cell Carcinoma
Sponsor:
SRH Wald-Klinikum Gera GmbH
Organization:
SRH Wald-Klinikum Gera GmbH
Study Overview
Official Title:
A Phase II Single-armed Multicenter Trial of Neoadjuvant Vismodegib in Patients With Large andor Recurrent Resectable Basal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NICCI
Brief Summary:
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 eg 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
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None