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Study Title and Description

Electronic brachytherapy for superficial and nodular basal cell carcinoma: a report of two prospective pilot trials using different doses.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Electronic brachytherapy for superficial and nodular basal cell carcinoma: a report of two prospective pilot trials using different doses.
Author Ballester-Sánchez R., Pons-Llanas O., Candela-Juan C., Celada-Álvarez FJ., Barker CA., Tormo-Micó A., Pérez-Calatayud J., Botella-Estrada R.
Country Dermatology Department.
Year 2016
Numbers Pubmed ID: 26985197

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 brachytherapy 36.6 Gy
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2 brachytherapy 42 Gy
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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. Single center
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Country/Region Spain
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Funding Industry funded
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Inclusion criteria adults with a primary superficial or nodular BCC with T1 and T2 clinical stage
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Exclusion criteria lesions bigger than 20 mm, deeper than 4 mm, or located on irregular surfaces
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N Enrolled/Randomized/Analyzed 40
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40
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... All BCC’s were confirmed by histopathologic examination
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Preoperative assessment of clinical size of the tumor ... visual ... Lateral margin delimitation was assessed clinically and aided by a dermoscope
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Percent non-primary (recurrent) 0
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Secondary size assessment
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Baseline Characteristics
Question brachytherapy 36.6 Gy brachytherapy 42 Gy Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 70 79
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3 2
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11.54 mm 12.2
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0.96 0.68
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Gender/Racial descent 10 8
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50 40
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Lesion location 15 (75%) head and neck 5 (25%) trunk and extremities 15 (75%) head and neck 5 (25%) trunk and extremities
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Skin type (Fitzpatrick score) 9 10
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45 50
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11 10
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55 50
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Number of lesions per patient No data entered.
Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 20 20
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20 20
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20 20
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20 20
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Lesion extent number of people 10 8
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50 40
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10 12
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50 60
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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 brachytherapy 36.6 Gy brachytherapy 42 Gy


up to 1 years

N Analyzed 20 20
Counts 2 1
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure brachytherapy 36.6 Gy brachytherapy 42 Gy


after treatment (unspecified) years

N Analyzed 20 20
Counts 12 11


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? No
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ALL.....Selective Reporting (judgement - put directly into notes field).
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RCT.....Is the treatment effect by Intention to treat?
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ALL....Group similarity at baseline. Unsure ages differ significantly; exact location of tumors not given
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field) Unsure Unclear results reporting
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined Unsure only 2 AEs reported, but those were reported well
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Overall, by outcome (judgement - put directly into notes field) high
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ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? No
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Quality Rating
No quality rating data was found.