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Study Title and Description

A phase II, multicenter, open-label, 3-cohort trial evaluating the efficacy and safety of vismodegib in operable basal cell carcinoma.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title A phase II, multicenter, open-label, 3-cohort trial evaluating the efficacy and safety of vismodegib in operable basal cell carcinoma.
Author Sofen H., Gross KG., Goldberg LH., Sharata H., Hamilton TK., Egbert B., Lyons B., Hou J., Caro I.
Country Department of Medicine/Dermatology, David Geffen School of Medicine at University of California-Los Angeles, Los Angeles, California. Electronic address: hsofen@ucla.edu.
Year 2015
Numbers Pubmed ID: 25913533

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 vismodegib 12 weeks
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2 vismodegib 12 weeks + 24 weeks observation
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3 vismodegib 16 weeks
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Design Details
Question... Follow Up Answer Follow-up Answer
Publication or abstract? Publication
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Study design Prospective nRCS
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Multicenter etc. Multicenter
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Country/Region U.S.
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Funding Industry funded
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Inclusion criteria Patients were 21 years of age or older, with new, operable, biopsy-confirmed, nodular BCC and willing to delay excision
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Exclusion criteria
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N Enrolled/Randomized/Analyzed 74
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49
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Notes/Comments Some information from NCT01201915
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... biopsy-confirmed
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Percent non-primary (recurrent) 0
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Secondary size assessment
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Baseline Characteristics
Question vismodegib 12 weeks vismodegib 12 weeks + 24 weeks observation vismodegib 16 weeks Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 60.5 65.2 65.1
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11.2 13.3 11.8
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59.0 65.0 61.0
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43, 81 40, 86 47, 89
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1.2 cm 1.5 1.2
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1, 3 1, 2 1, 3
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Gender/Racial descent 5 3 8
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21 12 32
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23 25 25
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96 100 100
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1
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4
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native american
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Lesion location Scalp/head/neck and cape area (100%) Scalp/head/neck and trunk/limbs (100%) Scalp/head/neck and trunk/limbs (100%)
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Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient No data entered.
Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 24 25 25
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24 25 25
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8 11 6
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8 11 6
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2 AE, 3 physician decision, 3 subject decision 1 AE, 4 lost to followup, 3 subject decision, 3 target lesion progression 1 AE, 5 subject decision
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16 14 19
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16 14 19
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Lesion extent number of people 100% 100% 100%
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Lack of histological clearance      Population: All Participants
Time Point Measure vismodegib 12 weeks vismodegib 12 weeks + 24 weeks observation vismodegib 16 weeks


at time of surgery (12, 36, 20) weeks

N Analyzed 16 14 19
Counts 6 10 8
Outcome: Lack of clinical clearance      Population: All Participants
Time Point Measure vismodegib 12 weeks vismodegib 12 weeks + 24 weeks observation vismodegib 16 weeks


at time of surgery (12, 36, 20) weeks

N Analyzed 16 14 19
Counts 6 5 1
Outcome: Adverse events: Any      Population: All Participants
Time Point Measure vismodegib 12 weeks vismodegib 12 weeks + 24 weeks observation vismodegib 16 weeks


at time of surgery (12, 36, 20) weeks

N Analyzed 24 25 25
Counts 24 25 24
Outcome: Adverse events: Any serious/severe      Population: All Participants
Time Point Measure vismodegib 12 weeks vismodegib 12 weeks + 24 weeks observation vismodegib 16 weeks


at time of surgery (12, 36, 20) weeks

N Analyzed 24 25 25
Counts 0 3 3


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported
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RCT:....Adequate allocation concealment reported
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RCT:....Adequate blinding of PATIENTS reported
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RCT:....Adequate blinding of PROVIDERS reported
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ALL....Adequate blinding of OUTCOME ASSESSORS reported No
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ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? Yes
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ALL.....Selective Reporting (judgement - put directly into notes field). No
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RCT.....Is the treatment effect by Intention to treat?
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ALL....Group similarity at baseline. Unsure From the baseline table, yes, but the number in each region for each arm is not given.
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field)
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined Yes
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Overall, by outcome (judgement - put directly into notes field)
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ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? Yes
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Quality Rating
No quality rating data was found.