The purpose of the present study was to determine the outcome of intraoperative radiotherapy as an boost dose in non-metastatic breast cancer undergoing breast conserving surgery.
Design
This study is a phase two single group clinical trial without blinding.
Settings and conduct
This multicenter phase II clinical trial study was performed in two radiotherapy centers of Omid Radiology Hospital and Imam Reza Hospital Radiotherapy in 1396-1989.
Participants/Inclusion and exclusion criteria
Patients with clinical stage I and II breast cancer candidates for breast conserving surgery with whole breast radiotherapy were enrolled. Pregnant and lactating patients and patients undergoing neoadjuvant chemotherapy were excluded.
Intervention groups
Patients underwent standard leptectomy with a margin of at least one mm and underwent intraoperative radiation therapy with boost dose of 20 gray with the ZEISS INTRABEAM 50-kV X-ray System. External whole-breast radiotherapy with a dose of 50 gray and, if needed, supraclavicular administration with a total dose of 45-50 gray or hypofractionation to the whole breast was performed with 16 sessions of 2.66 gray was prescribed.
Results of intraoperative radiotherapy as a boost in non-metastatic breast cancer undergoing breast conservation surgery
Public title
Intraoperative radiotherapy during breast cancer surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pathologic diagnosis of invasive ductal breast cancer
Breast cancer with size less than or equal to 3 cm
No lymph node involvement
No distant metastases
Exclusion criteria:
Pregnancy
Lactation
Active collagen vascular diseases such as scleroderma
Previous radiotherapy in diseases such as Hodgkin's lymphoma
Multifocal breast cancer
Presence of distant metastasis
Age
From 35 years old to 65 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2017-12-13, 1396/09/22
Ethics committee reference number
IR.MUMS.fm.REC.1396.588
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
Disease free survival
Timepoint
Two years after completion of treatment
Method of measurement
Physical examination and breast imaging
2
Description
Overall survival
Timepoint
Two years after completion of treatment
Method of measurement
Follow up of patient
3
Description
Skin toxicity
Timepoint
Two years after completion of treatment
Method of measurement
Physical examination based on toxicity criteria of the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer
4
Description
Subcutaneous toxicity
Timepoint
Two years after completion of treatment
Method of measurement
Physical examination based on toxicity criteria of the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: During breast-conserving surgery, patients will be treated with INTRABEAM 50-kV X-ray source at a dose of 20 Gy. Postoperatively, patients will receive systemic treatment according to the NCCN 2017 Clinical Guidelines as appropriate, including chemotherapy, hormone therapy, and targeted therapy. whole-breast external beam radiotherapy at a dose of 50 Gy and supraclavicular lymph node at a total dose of 45-50 Gy or hypofractionation to the whole breast at 16 sessions of 2.66 cGy will be subjected to hormone therapy if positive.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Kazem Anvari
Street address
Koohsangi Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3842 6082
Fax
+98 51 3842 8622
Email
OMH.LIB@mums.ac.ir
Web page address
http://omid.mums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Kazem Anvari
Street address
Emam Reza Hospital Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
emamreza@mums.ac.ir
Web page address
http://emamreza.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 8384 1538
Fax
+98 51 3841 2081
Email
RamResearch@mums.ac.ir
Web page address
http://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
960832
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Elyar Mousa Pour Shahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Omid hospital, Koohsangi Ave., Shariati Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3842 6936
Fax
+98 51 3842 8622
Email
MousapourSE951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Kazem Anvari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Omid Hospital, Koohsangi Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3842 6936
Fax
+98 51 3842 8622
Email
AnvariK@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elyar Mousa Pour Shahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Omid hospital, Koohsangi Ave., Shariati Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3842 6936
Fax
+98 51 3842 8622
Email
MousapourSE951@mums.ac.ir
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
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data is shared after unidentifiable people
When the data will become available and for how long
Start of access period 6 months after publication of results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For future research purposes and data comparisons, future studies of data are available.
From where data/document is obtainable
Contact Dr. Anvari, Project Manager, for request any data/document with AnvariK@mums.ac.ir and the address of Mashhad, Koohsangi Ave, Omid Hospital (postcode 9176613775).
What processes are involved for a request to access data/document
After submitting the request to the research team and the project coordinator, the request will be submitted to the Research Committee of the Oncology Radiotherapy Department of Mashhad University of Medical Sciences and decisions will be made on the success or rejection of the request.