Advanced Search

Study Preview



Study Title and Description

Higher recurrence rates of head and neck nodular basal cell carcinoma treated with topical photodynamic therapy (MAL-PDT) compared to surgical excision: A randomized controlled study



Key Questions Addressed
1 Comparison of interventions
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Higher recurrence rates of head and neck nodular basal cell carcinoma treated with topical photodynamic therapy (MAL-PDT) compared to surgical excision: A randomized controlled study
Author Abbade, Luciana; Tatiana Gige; Viviany Amaral; Sabrina Aquino; Helio Miot
Country
Year 2015
Numbers

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 Surgical excision
  • Comments Comments (
    0
    ) |
2 MAL-PDT
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Publication or abstract? Conference abstract
  • Comments Comments (
    0
    ) |
Study design RCT
  • Comments Comments (
    0
    ) |
Multicenter etc. Unclear
  • Comments Comments (
    0
    ) |
Country/Region Brazil
  • Comments Comments (
    0
    ) |
Funding NR
  • Comments Comments (
    0
    ) |
Inclusion criteria primary nodular BCC in the head and neck with a diameter up to two inches
  • Comments Comments (
    0
    ) |
Exclusion criteria no histologic confirmation of nodular BCC, Gorlin syndrome or contraindication to surgical resection or PDT.
  • Comments Comments (
    0
    ) |
N Enrolled/Randomized/Analyzed 92 lesions
  • Comments Comments (
    0
    ) |
68 lesions
  • Comments Comments (
    0
    ) |
68 lesions
  • Comments Comments (
    0
    ) |
Notes/Comments
  • Comments Comments (
    0
    ) |
Method of diagnosis ... Describe Biopsy/pathologic confirmation ...
  • Comments Comments (
    0
    ) |
Preoperative assessment of clinical size of the tumor ... not reported ...
  • Comments Comments (
    0
    ) |
Percent non-primary (recurrent) nd
  • Comments Comments (
    0
    ) |
Secondary size assessment
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question Surgical excision MAL-PDT Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines nd
  • Comments Comments (
    0
    ) |
Gender/Racial descent nd
  • Comments Comments (
    0
    ) |
Lesion location head and neck: 35, 100% head and neck: 33, 100%
  • Comments Comments (
    0
    ) |
Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient nd
  • Comments Comments (
    0
    ) |
Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 35 33 81
  • Comments Comments (
    0
    ) |
0 0 92
  • Comments Comments (
    0
    ) |
35 35 24
  • Comments Comments (
    0
    ) |
excluded
  • Comments Comments (
    0
    ) |
Lesion extent number of people 35 lesions 33 lesions
  • Comments Comments (
    0
    ) |
Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure Surgical excision MAL-PDT


6 months

N Analyzed 35 33
Counts 0 5


12 months

N Analyzed 35 33
Counts 0 2


18 months

N Analyzed 35 33
Counts 0 3


3+ years

N Analyzed 35 33
Counts 0 2
Outcome: Lack of histological clearance      Population: All Participants
Time Point Measure Surgical excision MAL-PDT


3 months

N Analyzed 35 33
Counts 0 3


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported No Data
  • Comments Comments (
    0
    ) |
RCT:....Adequate allocation concealment reported No Data
  • Comments Comments (
    0
    ) |
RCT:....Adequate blinding of PATIENTS reported No
  • Comments Comments (
    0
    ) |
RCT:....Adequate blinding of PROVIDERS reported No
  • Comments Comments (
    0
    ) |
ALL....Adequate blinding of OUTCOME ASSESSORS reported No Data
  • Comments Comments (
    0
    ) |
ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? No
  • Comments Comments (
    0
    ) |
ALL.....Selective Reporting (judgement - put directly into notes field). No
  • Comments Comments (
    0
    ) |
RCT.....Is the treatment effect by Intention to treat? Yes
  • Comments Comments (
    0
    ) |
ALL....Group similarity at baseline. Yes
  • Comments Comments (
    0
    ) |
ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field) No
  • Comments Comments (
    0
    ) |
ALL (with AE results)....Were reported adverse events (of interest) precisely defined No Data
  • Comments Comments (
    0
    ) |
Overall, by outcome (judgement - put directly into notes field) Overall moderate RoB due to incomplete reporting.
  • Comments Comments (
    0
    ) |
ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? No
  • Comments Comments (
    0
    ) |

Quality Rating
No quality rating data was found.