Comparison of the early skin toxicity and cosmetic outcome of concomitant boost radiotherapy with sequential boost radiotherapy after breast cancer conserving surgery
Assessment of the possibility of shortening the duration of breast cancer radiation therapy without increasing the side effects
Design
This is a phase 2 randomized clinical trial. The patients are randomized into two groups of concomitant boost and sequential boost. 50 patients are needed in each group (confidence interval 95%, power of 90%). Randomization was done with permuted block method.
Settings and conduct
This study was done at radiation oncology ward , cancer institute, Imam Khomeini hospital complex, Tehran university of medical sciences
Participants/Inclusion and exclusion criteria
18-75 years olds women with pathology proven breast cancer who have undergone breast conserving surgery would be included in the study. Those withe previous radiation therapy, previous cancer, previous skin disease, positive margin on surgery, or multi focal disease are excluded from the study.
Intervention groups
Radiotherapy with concomitant boost technique
Main outcome variables
َAcute skin side effects and cosmetic outcome after 6 month and 1 year after radiation completion.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220221054089N1
Registration date:2022-06-22, 1401/04/01
Registration timing:retrospective
Last update:2022-06-22, 1401/04/01
Update count:0
Registration date
2022-06-22, 1401/04/01
Registrant information
Name
reyhane bayani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1619
Email address
r.bayani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-12-27, 1398/10/06
Actual recruitment start date
2019-04-21, 1398/02/01
Actual recruitment end date
2020-02-29, 1398/12/10
Trial completion date
2021-02-28, 1399/12/10
Scientific title
Comparison of the early skin toxicity and cosmetic outcome of concomitant boost radiotherapy with sequential boost radiotherapy after breast cancer conserving surgery
Public title
Effect of boost technique on toxicity of breast cancer radiotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with pathologically proven breast cancer
Age 18-75
Undergoing breast conserving surgery
Early staged breast cancer (T1-3,N0-1)
Exclusion criteria:
Previous skin disease
Previous breast radiation
Previous cancer
Positive margin on surgery
Multifocal disease
Age
From 18 years old to 75 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done with permuted block method. In blocks with different sizes, patients were randomly assigned to two groups of concomitant boost and sequential boost by using random number tables.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences