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Study Title and Description

Photodynamic therapy vs. cryosurgery of basal cell carcinomas: results of a phase III clinical trial.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Photodynamic therapy vs. cryosurgery of basal cell carcinomas: results of a phase III clinical trial.
Author Wang I., Bendsoe N., Klinteberg CA., Enejder AM., Andersson-Engels S., Svanberg S., Svanberg K.
Country Departments of Oncology and Dermatology and Venereology, Lund University Hospital, SE-221 85 Lund, Sweden.
Year 2001
Numbers Pubmed ID: 11298545

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 ALA-PDT
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2 cryosurgery
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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. Single center
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Country/Region England
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Funding Industry funded
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Inclusion criteria histopathologically verified BCC suitable for PDT and cryosurgery, age 20-90 y
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Exclusion criteria pregnancy/lactation; severe malignancies; daily intake of vitamins E or C, b-carotene, iron preparations, non-steroidal anti-inflammatory agents or strong analgesics in higher than specified doses; BCC on the nose; morphoeic growth; porphyria; abdominal pain of unknown aetiology; photosensitivity;and treatment of the BCC with topical steroids type III or IV within the last month.
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N Enrolled/Randomized/Analyzed 88
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88
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83
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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) nd
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Secondary size assessment
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Baseline Characteristics
Question ALA-PDT cryosurgery Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 42-88
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Gender/Racial descent 44
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50
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Lesion location 10, 6
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11, 7
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legs, arms
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47, 25
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54, 28
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trunk, head/neck
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Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient 47 41
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100 100
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Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 47 41
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47 41
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47 41
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47 41
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0 2
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0 2
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44 nd
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44 39
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39
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Lesion extent number of people 22 17
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25 24
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure ALA-PDT cryosurgery


1 years

N Analyzed 42 37
Counts 21 3
Outcome: Lack of clinical clearance      Population: All Participants
Time Point Measure ALA-PDT cryosurgery


1 years

N Analyzed 44 39
Counts 2 5
Percentage 5 13
Outcome: Lack of histological clearance      Population: All Participants
Time Point Measure ALA-PDT cryosurgery


1 years

N Analyzed 44 39
Counts 11 6
Percentage 25 15
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure ALA-PDT cryosurgery


1 years

N Analyzed 42 37
Counts 18 17
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure ALA-PDT cryosurgery


1 years

N Analyzed 42 37
Counts 1 7
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure ALA-PDT cryosurgery


1 years

N Analyzed 42 37
Counts 2 10
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure ALA-PDT cryosurgery


1 years

N Analyzed 44 39
Counts 11 6
Percentage 25 15


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported No Data
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RCT:....Adequate allocation concealment reported Unsure
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RCT:....Adequate blinding of PATIENTS reported No No blinding regimen was possible due to the nature of the treatment procedures.
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RCT:....Adequate blinding of PROVIDERS reported No No blinding regimen was possible due to the nature of the treatment procedures.
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ALL....Adequate blinding of OUTCOME ASSESSORS reported No Data
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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? Yes
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ALL....Group similarity at baseline. Unsure The two treatment groups were comparable concerning medical history of the patients and status at the medical examination.
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field) No
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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) low to moderate due to poor reporting
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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.