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Study Title and Description

Basal cell carcinoma of the face: surgery or radiotherapy? Results of a randomized study.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Basal cell carcinoma of the face: surgery or radiotherapy? Results of a randomized study.
Author Avril MF., Auperin A., Margulis A., Gerbaulet A., Duvillard P., Benhamou E., Guillaume JC., Chalon R., Petit JY., Sancho-Garnier H., Prade M., Bouzy J., Chassagne D.
Country Service de dermatologie, Institut Gustave Roussy, Villejuif, France.
Year 1997
Numbers Pubmed ID: 9218740

Secondary Publication Information
UI Title Author Country Year
Evaluation of cosmetic results of a randomized trial comparing surgery and radiotherapy in the treatment of basal cell carcinoma of the face. Petit JY., Avril MF., Margulis A., Chassagne D., Gerbaulet A., Duvillard P., Auperin A., Rietjens M. Plastic Surgery Department, European Institute of Oncology, Milan, Italy. jypetit@ieo.cilea.it 2000
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Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 surgery
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2 radiotherapy
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Design Details
Question... Follow Up Answer Follow-up Answer
Publication or abstract? Publication
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Study design RCT
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Multicenter etc. Unclear
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Country/Region France
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Funding NR
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Inclusion criteria previously untreated BCC of the face, diameter < 4 cm.
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Exclusion criteria contraindication to surgery and radiotherapy, BCC on the scalp or the neck, patients with total removal of BCC at biopsy, patients with five or more BCCs and patients with a life expectancy of below 3 years
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N Enrolled/Randomized/Analyzed 360
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360
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347
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ...
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Preoperative assessment of clinical size of the tumor ... not reported ...
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Percent non-primary (recurrent) 0
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Secondary size assessment
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Baseline Characteristics
Question surgery radiotherapy Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 66.5 65.4
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12.6 11.5
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11.1 mm 11.7
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5.7 5.7
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mean of largest diameter mean of largest diameter
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Gender/Racial descent 94 79
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54 46
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Lesion location 174 173
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100 100
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Nose 53 (30) Cheek, pre- and retroauricular areas 36 (21) Eyelids, internal and external eye angles 34 (19) Forehead, temple, between eyebrows 36 (21) Chin, cutaneous superior lip 10 (6) Ear 5 (3) Nose 49 (28) Cheek, pre- and retroauricular areas 42 (24) Eyelids, internal and external eye angles 35 (20) Forehead, temple, between eyebrows 29 (17) Chin, cutaneous superior lip 12 (7) Ear 6 (3)
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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 180 180
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180 180
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180 180
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180 180
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6 7
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6 7
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2 decided to be treated elsewhere; 3 refused treatment; 1 seborrhoeic keratosis. 1 decided to be treated elsewhere; 6 refused treatment
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174 173
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174 173
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Lesion extent number of people 36/52 41/50
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superficial/ulcerated superficial/ulcerated
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79 74
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7 8
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure surgery radiotherapy


41 months

N Analyzed 174 173
Counts 1 8
Outcome: Lack of clinical clearance      Population: All Participants
Time Point Measure surgery radiotherapy


41 months

N Analyzed 174 173
Counts 0 3
Outcome: Adverse events: scarring      Population: All Participants
Time Point Measure surgery radiotherapy


4 years

N Analyzed 174 173
Percentage 30 0
Counts 52 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure surgery radiotherapy


4 years

N Analyzed 174 173
Percentage 0 65
Counts 0 112
Outcome: Adverse events: other      Population: All Participants
Time Point Measure surgery radiotherapy


4 years

N Analyzed 174 173
Percentage 0 41
Counts 0 71
Outcome: Adverse events: other      Population: All Participants
Time Point Measure surgery radiotherapy


4 years

N Analyzed 174 173
Counts 1 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure surgery radiotherapy


4 years

N Analyzed 174 173
Counts 0 2 (one of each)
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure surgery radiotherapy


6 months

N Analyzed 147 154
Counts 114 112


12 months

N Analyzed 151 149
Counts 124 113


24 months

N Analyzed 150 141
Counts 126 104


36 months

N Analyzed 137 127
Counts 109 85


48 years

N Analyzed 131 113
Counts 106 75
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure surgery radiotherapy


6 months

N Analyzed 147 154
Counts 140 149


12 months

N Analyzed 151 149
Counts 148 143


24 months

N Analyzed 150 141
Counts 148 135


36 months

N Analyzed 137 127
Counts 129 117


48 years

N Analyzed 131 113
Counts 119 99
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure surgery radiotherapy


6 months

N Analyzed 147 154
Counts 97 98


12 months

N Analyzed 151 149
Counts 111 96


24 months

N Analyzed 150 141
Counts 116 84


36 months

N Analyzed 137 127
Counts 103 63


48 years

N Analyzed 131 113
Counts 103 45
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure surgery radiotherapy


6 months

N Analyzed 147 154
Counts 143 150


12 months

N Analyzed 151 149
Counts 151 144


24 months

N Analyzed 150 141
Counts 148 134


36 months

N Analyzed 137 127
Counts 136 122


48 years

N Analyzed 131 114
Counts 128 99
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure surgery radiotherapy


6 months

N Analyzed 147 154
Counts 52 54


12 months

N Analyzed 151 149
Counts 66 54


24 months

N Analyzed 150 141
Counts 71 43


36 months

N Analyzed 137 127
Counts 74 42


48 years

N Analyzed 131 113
Counts 64 28
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure surgery radiotherapy


6 months

N Analyzed 147 154
Counts 105 103


12 months

N Analyzed 151 149
Counts 131 119


24 months

N Analyzed 150 141
Counts 116 98


36 months

N Analyzed 137 127
Counts 95 88


48 years

N Analyzed 131 113
Counts 92 65
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure surgery radiotherapy


6 months

N Analyzed 147 154
Counts 60 53


12 months

N Analyzed 151 149
Counts 68 57


24 months

N Analyzed 150 141
Counts 72 35


36 months

N Analyzed 137 127
Counts 56 31


48 years

N Analyzed 131 113
Counts 52 23
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure surgery radiotherapy


6 months

N Analyzed 147 154
Counts 111 116


12 months

N Analyzed 151 149
Counts 110 113


24 months

N Analyzed 150 141
Counts 116 102


36 months

N Analyzed 137 127
Counts 98 93


48 years

N Analyzed 131 113
Counts 90 69
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure surgery radiotherapy


6 months

N Analyzed 147 154
Counts 72 69


12 months

N Analyzed 151 149
Counts 68 65


24 months

N Analyzed 150 141
Counts 73 51


36 months

N Analyzed 137 127
Counts 56 48


48 years

N Analyzed 131 113
Counts 56 34
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure surgery radiotherapy


6 months

N Analyzed 147 154
Counts 123 122


12 months

N Analyzed 151 149
Counts 120 114


24 months

N Analyzed 150 141
Counts 121 107


36 months

N Analyzed 137 127
Counts 101 95


48 years

N Analyzed 131 113
Counts 96 76


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Unsure method of randomization not reported
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RCT:....Adequate allocation concealment reported Yes
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RCT:....Adequate blinding of PATIENTS reported No The lack of blinding is concerning for patient and physician reported cosmetic outcomes, but they also report outcomes from third-party blinded assessors
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RCT:....Adequate blinding of PROVIDERS reported No The lack of blinding is concerning for patient and physician reported cosmetic outcomes, but they also report outcomes from third-party blinded assessors
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ALL....Adequate blinding of OUTCOME ASSESSORS reported No The lack of blinding is concerning for patient and physician reported cosmetic outcomes, but they also report outcomes from third-party blinded assessors
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ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? Yes 23% and 27% lost to followup by mean followup time of 41 months
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ALL.....Selective Reporting (judgement - put directly into notes field). Neither paper reported AEs adequately
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RCT.....Is the treatment effect by Intention to treat? Unsure ITT not reported, low number of dropouts
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ALL....Group similarity at baseline. Yes
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field) radiation subgroup analysis (by radiation method) not adequately reported. Some of the numbers in the results don't add up.
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined No they were reported, but not well defined
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Overall, by outcome (judgement - put directly into notes field) for cosmetic outcomes, the numbers don't add up, the binding was inadequate Overall moderate RoB
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ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? No similar rates between arms
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Quality Rating
No quality rating data was found.