Comparison of acute complications, late complications, and local control of hypofractionated and conventional radiotherapy of the chest/whole breast and regional lymph nodes
Design
Randomized clinical trial, with parallel groups in two groups of one hundred patients: conventional radiotherapy in 25 fraction and hypofractionated radiotherapy in 15 fraction, who will be assigned to one of the two groups in 1:1 blocks for randomization using a random number table (www.random.org).
Inclusion criteria:
Age 18-70 years
Performance level KPS≥70 or ECOG score=0-1)
Newly diagnosed breast cancer
Confirmed histological diagnosis
T3-4 tumor or lymph node involvement
Negative surgical margin
Exclusion criteria:
Unwillingness of patient
Chronic liver, heart, and kidney diseases
Previous chronic lung disease including pulmonary fibrosis, COPD grade III, and asthma
Previous history of malignancy
Previous history of chest radiotherapy
Carcinoma in situ without invasive component
Metastasis at initial presentation
Connective tissue diseases
Positive surgical margin
Early stage tumor (T1-2N0) in which there is no indication for lymph node radiotherapy (low-risk patient)
Pregnancy
Intervention groups
For radiotherapy, all patients in both groups will be placed in the supine position and undergo CT simulation with 5 mm slices using the Breast Board. The breast/chest and axillary and supraclavicular lymph nodes will be contoured according to RTOG criteria. The treatment dose will be 50 Gy for conventional radiotherapy and 43.5 Gy for hypofractionated radiotherapy.
Main outcome variables
Acute and local complications equivalent to hypofractionation and conventional treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250728066668N1
Registration date:2025-08-01, 1404/05/10
Registration timing:prospective
Last update:2025-08-01, 1404/05/10
Update count:0
Registration date
2025-08-01, 1404/05/10
Registrant information
Name
Najme Radmard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3320 7401
Email address
radmardnajme1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-06, 1404/05/15
Expected recruitment end date
2025-10-07, 1404/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Of Local Control And Complications Of Hypofractionated Radiotherapy With Conventional In Patients With Advanced Breast Cancer
Public title
Comparison Of Hypofractionated And Conventional Radiotherapy In Advanced Breast Cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All Patients With Advanced Breast Cancer And Confirmed Histologic Diagnosis With Negative Surgical Margin
Exclusion criteria:
Age
From 18 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be enrolled in the study sequentially and based on the order of referral for the start of radiotherapy. Then, patients will be randomly assigned to one of the two study groups using a random number table (by the site https://www.random.org) in 1:1 blocks. An attempt will be made to ensure that patients are the same in terms of age, gender, performance level, initial stage, molecular class, and tumor location in the two groups.
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 Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz St. ,Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2025-04-13, 1404/01/24
Ethics committee reference number
IR.MUBABOL.HRI.REC.1404.005
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Acute Complication of Hypofraction And Conventional
Timepoint
Patients will be seen weekly during radiotherapy and once a month afterwards for treatment complications
Method of measurement
A checklist designed based on CTCAE v5.0 (radiotherapy-induced dermatitis), RTOG (subcutaneous toxicity) and SOMA/LENT (telangiectasia, hand edema, pain in the radiotherapy area) will be completed to review the complications of interest
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group:Patients with advanced breast cancer undergo hypofractionated radiotherapy treatment for three weeks. During treatment, they are monitored weekly for complications based on the aforementioned criteria, and a follow-up visit is made one month after the end of treatment to check for symptoms.
Category
Treatment - Other
2
Description
Control group: This group of patients underwent conventional radiotherapy for five weeks according to standard treatment and were monitored weekly during treatment and then one month after treatment for the occurrence of acute symptoms.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee Hospital, Babolsar
Full name of responsible person
Masoumeh Karimi
Street address
Shahid Rjaee Hospital,Shriati St,Babolsar
City
Babaolsar
Province
Mazandaran
Postal code
4741999879
Phone
+98 11 3528 9258
Email
rajaee@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Babol University of Medical Science Ganjafrooz St.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
info@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Najme Radmard
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Babol University of Medical Science, Gangafrooz St.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
Radmardnajme1@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Danial Fazilatpanah
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Shahid Rajaee Hospital, Shariati St.
City
Babolsar
Province
Mazandaran
Postal code
4741999879
Phone
+98 11 3528 9259
Email
drfazilatpanah@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Najme Radmard
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Babol University of Medical Science, Gangafrooz St.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
Radmardnajme1@gmail.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
Undecided - It is not yet known if there will be 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
Yes - There is a plan to make this available
Title and more details about the data/document
The files are in Excel format and include age, treatment complications, hormone receptors, etc. and can be shared.
When the data will become available and for how long
6 months after results are published
To whom data/document is available
This information is available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Any type of analysis on the delivered data is permitted.
From where data/document is obtainable
Please Contact to the Public Accountability Officer
Najme Radmard
Radmardnajme1@gmail.com
What processes are involved for a request to access data/document
After receiving and viewing the application email and confirming the applicant, the files will be sent within a maximum of one month.