Evaluation of early toxicity of daily and weekly concomitant boost in comparison with conventional boost in early stage breast cancer patients treated with hypofractionated Radiotherapy in 2019-2020 at Cancer Institute of Tehran
To evaluate and comparison of acute toxicity skin tozicity of 3 arm
Design
3-arm randomized clincal trial with control group
Settings and conduct
The sampling is done over patients come to radioncology department of Cancer Institute of Emam Khomeini Hospital Complex
Participants/Inclusion and exclusion criteria
Female older than 18, with stage 1 or 2 breast cancer who underwent breast conservative surgery with negative margin and lymph node
Excluding:
positive LN at axillary dissection
Multifocal tumour,
Paget’s disease,
pathological skin involvement,
synchronous or previous breast cancer,
other malignant disease,
pregnant or lactating
Previous irradiation to ipsilateral breast or thorax
Intervention groups
In the weekly concomitant boost dose of 9 grey in 3 fraction, 3grey per fraction over thursday is given
And in the daily concomitant boost dose of 8 grey in 16 fraction, .05 Grey per fraction is given everyday of RT
Main outcome variables
Skin changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201106049287N1
Registration date:2021-12-14, 1400/09/23
Registration timing:retrospective
Last update:2021-12-14, 1400/09/23
Update count:0
Registration date
2021-12-14, 1400/09/23
Registrant information
Name
Naeim Nabian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7751 3217
Email address
naeim_nabian2@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
2019-11-30, 1398/09/09
Actual recruitment end date
2021-06-20, 1400/03/30
Trial completion date
2021-07-21, 1400/04/30
Scientific title
Evaluation of early toxicity of daily and weekly concomitant boost in comparison with conventional boost in early stage breast cancer patients treated with hypofractionated Radiotherapy in 2019-2020 at Cancer Institute of Tehran
Public title
Evaluation of early toxicity of daily and weekly concomitant boost in comparison with conventional boost in early stage breast cancer patients treated with hypofractionated Radiotherapy in 2019-2020 at Cancer Institute of Tehran
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female
Older than 18
Stage 1 or 2
Breast conservating surgery
Negative margin
Negative lymph node
Exclusion criteria:
positive LN at axillary dissection
Multifocal tumour
Paget’s disease
pathological skin involvement,
synchronous or previous breast cancer,
other malignant disease,
pregnant or lactating patient
Previous irradiation to ipsilateral breast or thorax
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
92
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be determined by random blocking method with 4 blocks and using the table of random numbers by Random Allocation Software. Random assignment to intervention and control groups, description of how to block and allocation sequence for concealment will be done by the person not involved in the research (Allocation Concealment). The allocation ratio of the samples will be (Allocation 1: 1: 1). Patients will be divided into 3 groups receiving Boost radiation therapy weekly, daily and control (Assignment). Then, based on the obtained blocks and in the order of allocation, patients will be treated. This study is Open-Label and will not be blinded.
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 committe of Emam Khomeini Hospital Complex of Tehran University of Medical Science
Street address
Keshavarz Blvd, Dr.Gharib Street
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2019-11-27, 1398/09/06
Ethics committee reference number
IR.TUMS.IKHC.REC.1398.224
Health conditions studied
1
Description of health condition studied
Radiotherpy in Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Skin Reactin
Timepoint
After Radiotherapy, 1 month later, every 3 months up to 1 year
Method of measurement
Use NCI CTCAE version 3.0 toxicity criteria and rates of acute toxicity
Secondary outcomes
1
Description
cosmetic result
Timepoint
3 months
Method of measurement
Comparison with healthy opposite breasts in size, indentation, shape and symmetry
Intervention groups
1
Description
Intervention group: daily concurrent RT boost. In the concomitant boost group, a total dose of 8 grey will be treated with 50 c-grey daily with basic radiotherapy.
Category
Treatment - Other
2
Description
Intervention group: weekly RT boost. In the weekly concomitant boost group, a total dose of 9 grey in 3 sessions on Thursdays of each week will be treated with a dose of 3 grey in each session.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital Complex
Full name of responsible person
Naeim Nabian
Street address
Keshavar Blvd, Dr.Gharib Street
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2834
Email
imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraeian
Street address
Imam khomeini Hospital, Blv Keshavarz
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2834
Email
naeim_nabian2@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Naeim Nabian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Imam khomeini Hospital, Blv Keshavarz
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2834
Email
naeim_nabian2@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Naeim Nabian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Imam khomeini Hospital, Blv Keshavarz
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2834
Email
naeim_nabian2@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Naeim Nabian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Imam khomeini Hospital, Blv Keshavarz
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2834
Email
Naeim_nabian2@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Charctristics of patients based on age, TNM staging, hormone receptor, quality and quantity of toxicities and cosmetic results
When the data will become available and for how long
Between 6 months or 1 year after publication
To whom data/document is available
Just researchers at university or scientific organizations
Under which criteria data/document could be used
Not pre spcified
From where data/document is obtainable
Email the writer
Naeim_nabian2@yahoo.com
What processes are involved for a request to access data/document
The applicant must have submitted their identity information or that of the company in question. Also, the analyzes that are to be done on the data must be sent in advance. And after about 1-3 months, the result of the request will be announced.