Clinical Trial: Study Evaluating the Interest of Vismodegib as Neo-adjuvant Treatment of Basal Cell Carcinoma (BCC)
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Phase II Study Evaluating the Interest of Vismodegib as Neo-adjuvant Treatment of Basal Cell Carcinoma (BCC)
Brief Summary: Open-label, non-comparative, multicenter, phase II study of Vismodegib in patients with locally advanced BCC.
Detailed Summary:
Enrolled patients will receive continuous once-daily oral dosing of Vismodegib at a dosage of 150 mg (in accordance with the product SmPC) per administration. One cycle of therapy will be defined as 28 days of treatment. The treatment will be renewed once a month depending on the product tolerance.
The trial will consist of a Screening Period (Day -28 to -1), a Treatment Period (Day 1 to BOR), one End of Treatment Visit, one Surgery Visit and 8 Safety Follow-Up Visits after the last dose of Vismodegib (+/- 5 days). Day 1 of the study will be defined as the first day a patient receives Vismodegib.
Sponsor: University Hospital, Lille
Current Primary Outcome: the change in surgery stages [ Time Frame: Between baseline and maximum 10 months of treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of patients with locally advanced BCC with down-staging of surgical procedures with Vismodegib [ Time Frame: from 4 to 10 months of treatment ]
- Gravity index related to the surgical or functional results (global score) [ Time Frame: At maximum 10 months of treatment ]
- Score of the clinical benefits at BOR [ Time Frame: At maximum 10 months of treatment ]
- Assessment of treatment toxicity according to NCI-CTC, v4.0 [ Time Frame: 2 months after the surgery and maximum 12 months after the Vismodegib initiation ]National Cancer Institute - CommonToxicity Criteria (NCT-CTC) for the recognition and grading severity of adverse effects of chemotherapy
- Quality of life assessment by Skindex-16 questionnaire [ Time Frame: At screening, at 3 months, at 6 months of treatment ]
- the tumor recurrence rate [ Time Frame: at 3 years of follow-up ]
- the cytological response by biopsy [ Time Frame: from 4 to 10 months of treatment ]
Original Secondary Outcome:
- Number of patients with locally advanced BCC with down-staging of surgical procedures with Vismodegib [ Time Frame: from 4 to 10 months of treatment ]
- Gravity index related to the surgical or functional results (global score) [ Time Frame: At maximum 10 months of treatment ]
- Score of the clinical benefits at BOR [ Time Frame: At maximum 10 months of treatment ]
- Assessment of treatment toxicity according to NCI-CTC, v4.0 [ Time Frame: 2 months after the surgery and maximum 12 months after the Vismodegib initiation ]
- Quality of life assessment by Skindex-16 questionnaire [ Time Frame: At screening, at 3 months, at 6 months of treatment ]
- the tumor recurrence rate [ Time Frame: at 3 years of follow-up ]
- the cytological response by biopsy [ Time Frame: from 4 to 10 months of treatment ]
Information By: University Hospital, Lille
Dates:
Date Received: January 20, 2016
Date Started: November 2014
Date Completion: December 2020
Last Updated: January 17, 2017
Last Verified: January 2017