Comparison of cancer free survival, early & late (after 6 & 12 monthes) complications, surgical complications & cosmetic results in early stage breast cancer patients were treated with neoadjuvant radiotherapy with adjuvant
Design
A randomized, controlled clinical trial with four arm and parallel groups
Settings and conduct
120 early breast cancer patients referred to Shohaday-e-haftom-e-tir & Rasoul- e-akram Hospital are divided into 4 groups using a random number table. Patients in the control group receive 50Gy as adjunct and interventional group, as neoadjuvant and the boost of each arm is given in the form of a 12Gy as IORT or 10Gy in a conventional manner. The intervention group is referred 4 to 6 weeks after the completion of radiotherapy to undergo surgery. Both groups receive chemotherapy and hormone therapy.
Then, cancer free survival, and early ,delayed & surgical complications and cosmetic results are compared in 4 arms
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Women aged 18 to 75 years with breast cancer with stage T1-T2 / N0 / M0, which have ER + and HER2-
Candidate for Radiation Therapy
For the first time, they have had cancer
Exclusion criteria:
Earlier history of radiation therapy
Intervention groups
First group: patients undergoing neoadjuvant radiotherapy and IORT boost and then chemotherapy and hormone therapy
Second group: patients undergoing neoadjuvant radiotherapy and conventional boost and then chemotherapy and hormone therapy
Third group: Patients undergoing surgery and chemotherapy, then receive radiation therapy with boost during surgery (control group)
Fourth group: Patients undergoing surgery and chemotherapy receive radiotherapy and boost dose as conventional (control group)
Main outcome variables
cancer free survival, early complications, late complications, cosmetic outcomes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180919041070N1
Registration date:2019-04-04, 1398/01/15
Registration timing:registered_while_recruiting
Last update:2019-04-04, 1398/01/15
Update count:0
Registration date
2019-04-04, 1398/01/15
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
2019-01-21, 1397/11/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of neoadjuvant with adjuvant radiotherapy in patients with early breast cancer
Public title
Effect of radiotherapy time in breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with breast cancer with stage T1-T2 / N0 / M0, which have ER + and HER2--
Candidate for Radiation Therapy
For the first time, they have had cancer
age between 18 to 70 years
Exclusion criteria:
Earlier history of radiation therapy
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:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization
Random unit: Individual
Randomization Tool: Random Number table
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 Iran University of Medical Sciences
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
Approval date
2018-12-22, 1397/10/01
Ethics committee reference number
IR.IUMS.REC.1397.704
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
cancer free survival
Timepoint
Every 3 months until two years
Method of measurement
absence of recurrence disease based on examination and ultrasound and mammography
2
Description
Acute skin toxicity due to radiation therapy
Timepoint
Weekly evaluation during radiotherapy and then 4 and 12 weeks after radiotherapy
Method of measurement
Based on acute radiation dermatitis common toxicity criteria
3
Description
Late skin toxicity due to radiation therapy
Timepoint
6 months after radiotherapy and then every 3 months until one year
Method of measurement
Using the RTOG/EORTC radiation morbidity scoring scheme
4
Description
cosmetic results
Timepoint
Six months after radiotherapy and then every 6 months until 2 years
Method of measurement
RTOG (4 point scoring system), LENT-SOMA score and BCCT software
5
Description
Surgical complications including infection, not wound healing & seroma
Timepoint
After two weeks of surgery
Method of measurement
History,inspection location of ulcer and examination, and ultrasound to estimate the amount of seruma
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A group that received neoadjuvant radiation therapy (50 Gy in 25 fraction) and boost dose during surgery (12 Gy IORT)، then receive surgery, chemotherapy, and hormone therapy.
Category
Treatment - Other
2
Description
Intervention group: A group that received neoadjuvant radiation therapy (50 Gy in 25 fraction) and conventional boost dose (10 Gy in 5 fraction) , then receive surgery, chemotherapy, and hormone therapy.
Category
Treatment - Other
3
Description
Intervention group: A group that is undergoing surgery and chemotherapy, then receive adjuvant radiation therapy (50 Gy in 25 fraction) and boost dose during surgery (12 Gy IORT); then they receive hormone therapy.
Category
Treatment - Other
4
Description
Control group: A group that is undergoing surgery and chemotherapy, then receive adjuvant radiation therapy (50 Gy in 25 fraction) and conventional boost dose (10 Gy in 5 fraction); then they receive hormone therapy.
Category
Treatment - Other
Recruitment centers
1
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
2
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
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
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
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
End of Shahid Rajaee Street, Shahr-e-Ray
City
Tehran
Province
Tehran
Postal code
1886718136
Phone
+98 21 5522 8580
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
Nahid Nafisi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Rasoul Akram Hospital, Nayesh Street, Mansouri Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Email
Nafissi.n@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohadese Shahin
Position
Resident of Radiotherapy and Oncology
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
No. 16, Dashtestan 7th Ave., Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1947833953
Phone
+98 21 2284 3808
Email
mohadese.shahin@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Individual data of the participants in the study: The total potential data after being unidentifiable is the sharing of individuals
When the data will become available and for how long
Access 1 year after the results are published
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
If he want to do similar studies or meta-analysis and systematic review
From where data/document is obtainable
Applicants can send their request to the following email address to receive the requested data
Dr Mohaditha Shahin
Shohaday-e-haftom-e-tir hospital, End of Shahid Rajaee Street, Shahr-e-Ray
mohadese.shahin@gmail.com
What processes are involved for a request to access data/document
First, applicants send their request and proposal to following e-mail.
after study it, data will be sent within 10 days.
It should be noted that the applicant should be obliged to send me the result of his study immediately after the completion of the project.
mohadese.shahin@gmail.com