Purpose: comparing toxicity and cosmetic outcome of conventional and hypo fractionated radiotherapy with or without boost in breast cancer patients.
Design: randomized, not blinded, control with conventional radiotherapy, unicentric, phase III clinical trial.
Population: early stage breast cancer patients (T1-T2 N0) below 70 years old, who have undergone breast conserving surgery and fill in the informed consent enter the study. Patients who have history of collagen vascular diseases, and also if the radiotherapy field separation is more than 22Cm or ejection fraction is less than 50% or those who get lost in follow up are excluded from the study.
Iintervention: hypo fractionated radiotherapy with or without boost.
Time: from 14/05/2013 to 14/05/2016.
Outcome: skin, cardiac, pulmonary toxicity and cosmetic outcome
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014102519675N1
Registration date:2015-06-14, 1394/03/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-14, 1394/03/24
Registrant information
Name
Sare Hosseini
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 3842 6936
Email address
hosseinis@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing toxicity and cosmetic outcome of conventional and hypo fractionated radiotherapy with or without boost in breast cancer patients
Public title
The outcomes of hypo fractionated radiotherapy in breast cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with early stage breast cancer (T1-T2 N0) below 70 years old who have undergone breast conserving surgery and fill in the informed consent.
Exclusion criteria: history of collagen vascular disease; field separation more than 22Cm; ejection fraction less than 50%; lost in follow up.
Age
From 20 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
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
Mashhad University of Medical Sciences
Street address
Between Shahid Javan and Shahid Aleshahidi Sq, Shahid Fakori Blvd, Mashhad
City
Mashhad
Postal code
9177899191
Approval date
2014-06-14, 1393/03/24
Ethics committee reference number
920067/1/860
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50-C50
ICD-10 code description
malignant neoplasm of breast
Primary outcomes
1
Description
Skin toxicity
Timepoint
Every week during intervention then every two weeks in the first month after intervention and then every 3 months up to 2 years
Method of measurement
Based on NCCI Common Toxicity Criteria (CTC) version 20
2
Description
Cardiac toxicity
Timepoint
Before intervension and 4 months after intervention
Method of measurement
Echocardiography
3
Description
Lung toxicity
Timepoint
Before intervention , 6 and 12 months after intervention
Method of measurement
Spirometry
Secondary outcomes
1
Description
Cosmetic outcome
Timepoint
2 years after intervention
Method of measurement
Based on Harvard Criteria
Intervention groups
1
Description
Intervention: hypo fractionated radiotherapy with boost:
42.5 Gy total dose to breast using 2.66 Gy per fraction in 22 days with 6 MV photons with 2 to 2.5 Gy per fraction electron boost in 4 fractions
Category
Treatment - Other
2
Description
Intervention: hypo fractionated radiotherapy without boost:
42.5 Gy total dose to breast using 2.66 Gy per fraction in 22 days with 6 MV photons without electron boost
Category
Treatment - Other
3
Description
Control: standard breast radiotherapy: 50 Gy total dose to breast using 2 Gy per fraction in 35 days with 6 MV photons with 2 to 2.5 Gy per fraction electron boost in 4 fractions
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Roham Salek
Street address
Emam Reza Sq, Ebnesina St, Mashhad
City
Mashhad
2
Recruitment center
Name of recruitment center
Omid hospital
Full name of responsible person
Sare Hosseini
Street address
Alandasht Sq, Koohsangi St, Mashhad
City
Mashhad
3
Recruitment center
Name of recruitment center
Reza Radiotherapy Center
Full name of responsible person
Fatemeh Varshoee Tabrizi
Street address
19th Misagh, Haft Azar Sq, International Exhibition Blvd
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saied Eslami
Street address
Ghorshi building, Daneshgah St
City
Mashhad
Grant name
Grant code / Reference number
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sare Hosseini
Position
Assistant Professor
Other areas of specialty/work
Street address
Omid Hospital, Alandasht Sq, Koohsangi, Mashhad
City
Mashhad
Postal code
00989176613775
Phone
+98 51 3842 6936
Fax
+98 51 3842 6936
Email
hosseinis@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Roham Salek
Position
Associate Professor
Other areas of specialty/work
Street address
Emam Reza Sq, Ebnesina St, Mashhad
City
Mashhad
Postal code
00989137913316
Phone
+98 51 3802 2728
Fax
+98 51 3851 4947
Email
salekr@mums.ac.ir
Web page address
http://emamreza.mums.ac.ir/index.php
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sare Hosseini
Position
Assistant Professor
Other areas of specialty/work
Street address
Omid Hospital, Alandasht Sq, Koohsangi, Mashhad
City
Mashhad
Postal code
00989176613775
Phone
+98 51 3842 6936
Fax
+98 51 3842 6936
Email
hosseinis@mums.ac.ir
Web page address
http://www.mums.ac.ir/omid
Sharing plan
Deidentified Individual Participant Data Set (IPD)