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Comparison of short term results of IORT boost and hypofractionated EBRT after BCS with conventional whole breast radiotherapy and external boost in early breast cancers from 2019 to 2020

Protocol summary

Study aim
Prevalence of complications and aesthetic results of whole breast adjuvant radiotherapy after breast conservation surgery in early breast cancer patients with hypofractionated external beam radiotherapy with intraoperative boost and conventional external beam radiotherapy with external boost
Design
In this study, patients will be assigned to either conventional or hypofractionated radiotherapy groups (34 patients each) according to the physician's opinion for adjuvant radiotherapy (non-random)
Settings and conduct
At Rasool Akram and Khatam Al-Anbia Hospitals, patients with early breast cancer after breast conservation surgery will receive conventional external radiation therapy with conventional boost dose or hypofractionated radiation therapy with intraoperative boost dose
Participants/Inclusion and exclusion criteria
Inclusion criteria are pathologically confirmed breast cancer, age greater than 35 years, tumor size less than 5 centimeters, absence of nodal involvement or involvement of lesser than 3 nodes and margins without tumor involvement in postoperative pathology. Exclusion criteria are in-situ carcinoma without invasive component, tumoral adhesion to thoracic wall or inflammatory carcinoma, Karnofsky performance score<70, history of radiotherapy of chest wall, multiple breast masses greater than 5 centimeters apart, history of connective tissue diseases, previous chronic pulmonary disease, distant metastasis, large breast and pregnancy.
Intervention groups
In the conventional group: after breast conservation surgery, whole breast radiotherapy will be delivered externally with total dose of 50 gray plus boost does of 10 gray to tumor bed. In the hypofractionated group, 10 gray of intraoperative radiotherapy will be performed during surgery and then 42.56 gray of whole breast radiotherapy will be delivered externally.
Main outcome variables
Skin complications; cosmetic results

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180919041070N2
Registration date: 2019-12-03, 1398/09/12
Registration timing: registered_while_recruiting

Last update: 2019-12-03, 1398/09/12
Update count: 0
Registration date
2019-12-03, 1398/09/12
Registrant information
Name
Pedram Fadavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5522 8584
Email address
fadavi.p@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-16, 1398/08/25
Expected recruitment end date
2020-11-15, 1399/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of short term results of IORT boost and hypofractionated EBRT after BCS with conventional whole breast radiotherapy and external boost in early breast cancers from 2019 to 2020
Public title
Adjuvant radiotherapy method in breast cancer.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of breast cancer on pathological examination Age more than 35 year old Tumor size equal and less than 5 centimeter No regional nodal involvement or involvement of equal and less than 3 nodes in post surgical pathological examination Clear surgical margin in post surgical pathological examination
Exclusion criteria:
Presence of in-situ carcinoma without invasive component Tumoral adhesion to muscles of the chest wall Inflammatory carcinoma karnofsky performance status less than 70% Previous history of the chest wall irradiation Multiple tumoral masses with more than 5 centimeter distance A history of connective tissue diseases including lupus disease and scleroderma Previous chronic pulmonary disease including pulmonary fibrosis, grade III chronic obstructive pulmonary disease and asthma Distant metastasis large breast based on planning target volume in radiotherapy more than 2500 mililiter Pregnancy
Age
From 35 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Research Ethics Committee of Medical School of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
14665-354
Approval date
2019-10-20, 1398/07/28
Ethics committee reference number
IR.IUMS.FMD.REC.1398.319

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
Skin complication of radiotherapy
Timepoint
After the third week of radiotherapy and one year after the completion of radiotherapy
Method of measurement
National Cancer Institute Common Terminology Criteria for Adverse Events version 2.0

2

Description
Cosmotic outcome
Timepoint
[ne year after the completion of radiotherapy
Method of measurement
Objective Measurement of Cosmetic Outcomes

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In hypofractionated radiotherapy group, during breast conservation surgery, patients will receive intraoperative electron radiation therapy with 10 gray dose. Postoperatively, patients will receive systemic treatment as required by the National Comprehensive Cancer Network Guidelines, including chemotherapy and Target Therapy. Following completion of this treatment, patients will receive whole breast hypofractionated radiotherapy in 16 sessions at a total dose of 42.56 Gy.
Category
Treatment - Other

2

Description
Control group: In conventional radiotherapy group, patients will receive external radiation therapy with total dose of 50 gray that will be followed by 10 gray extra dose to the tumor bed after breast conservation surgery with negative margin as well as chemotherapy and targeted therapy.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul Akram Hospital, Nayesh Street, Mansouri Street, Sattarkhan Street
Full name of responsible person
Nahid Nafisi
Street address
Rasoul Akram Hospital, Nayesh Street, Mansouri Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Email
rcrdcc@iums.ac.ir
Web page address
http://rcrdc.iums.ac.ir

2

Recruitment center
Name of recruitment center
Shohaday-e-haftom-e-tir hospital
Full name of responsible person
Pedram Fadavi
Street address
End of Shahid Rajaee Street, Shahr-e-Ray
City
Tehran
Province
Tehran
Postal code
1886718136
Phone
+98 21 5522 8580
Fax
+98 21 5521 7901
Email
web7tir@iums.ac.ir
Web page address
http://new.iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Kazem Malekoti
Street address
Fifth Floor, Central Headquarters, Iran University of Medical Sciences, Hemet Highway Between Chamran and Sheikh Fazlollah
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Fax
+98 21 8862 2703
Email
research@iums.ac.ir
Web page address
Grant name
2859
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Pedram Fadavi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Shohadaie haftome tir hospital, Rajaei street, Ray town
City
Tehran
Province
Tehran
Postal code
۱۸۸۶۷۱۸۱۳۶
Phone
+98 21 5522 8584
Fax
Email
Fadavi.p@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Pedram Fadavi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Shohadaie haftome tir hospital, Rajaei street, Ray town
City
Tehran
Province
Tehran
Postal code
۱۸۸۶۷۱۸۱۳۶
Phone
+98 21 5522 8584
Fax
Email
Fadavi.p@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Bahareh Jafarnejadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Shohadaie haftome tir hospital, Rajaei street, Ray town
City
Tehran
Province
Tehran
Postal code
۱۸۸۶۷۱۸۱۳۶
Phone
+98 21 5522 8584
Fax
Email
bahareh.jn@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
After completing data collection, study protocols, statistical analysis maps and clinical study reports by publishing scientific articles and sharing them on virtual social networks such as Twitter and related educational channels, these will be made public. .
When the data will become available and for how long
These will be available after publication
To whom data/document is available
The medical community, researchers and the general public
Under which criteria data/document could be used
The medical community and researchers can request data to compare the results of this study with other studies in the field of breast radiotherapy.
From where data/document is obtainable
Dr Pedram Fadavi (Fadavi.p@iums.ac.ir)
What processes are involved for a request to access data/document
After receiving the data submission request, the request will be submitted to the Research Committee of the Radiotherapy Department of Iran University of Medical Sciences and, if approved, will be sent to the Research Ethics Committee of the Faculty of Medicine. Upon final confirmation of the request, the information will be sent by email.
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