Radiologic response evaloution after conventional whole brain radiation therapy plus concurrent oral adminestration of losartan versus radiotion therapy alone in patients with brain metastasis
Evaluation radiologic response to whole brain radiotherapy with adminstration concurrent oral losartan versus radiotherapy alone in brain metastasis
Design
Clinical trial with controlled group, with parallel group,double blinded, randomised
Settings and conduct
Patients with brain metastasis attending in radiotherapy ward of Ahvaz Golestan hospital and with eligible criteria divided into two groups.intervention group will received the standard whole brain radiotherapy and oral Losartan, whereas the control group will treated with standard whole brain radiotherapy and placebo. Participant and researcher are unaware which group receive drug, and which group receive the placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria included patients with a Pathology confirmed extracranial malignancy & MRI suggest brain metastasis.exclusion criteria included the lack of history of previous brain radiotherapy or radiosurgery & no previus treatment with angiotenssin converting enzyme inhibitors and angiotenssin receptor blockers.
Intervention groups
Intervention group will received 30 Gray in 10 fractions whole brain radiotherapy and 25 milligram Losartan as a radiosensitizer during radiation course. The control group will received the same radiation dose and placebo.
Main outcome variables
Radiologic response of brain lesions to radiation with adding Losartan as a radiosensitizer will be investigated.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170314033080N2
Registration date:2018-03-11, 1396/12/20
Registration timing:prospective
Last update:2018-03-11, 1396/12/20
Update count:0
Registration date
2018-03-11, 1396/12/20
Registrant information
Name
Yasamin Mahouram
Name of organization / entity
Ahvaz Jundishapour University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61 3321 9277
Email address
mahouram.y@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
no charge from any institute
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Radiologic response evaloution after conventional whole brain radiation therapy plus concurrent oral adminestration of losartan versus radiotion therapy alone in patients with brain metastasis
Public title
Effect of losartan with whole bain radiotherapy in brain metastasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Extracranial metastasis confirmed by pathology
MRI imaging suggestive for brain metastasias with at least 1 cm in size
Predicted survival at least 8 weeks for patient
Zubrud performance scale 0, 1, 2, 3
Absolout neutrophil count>1000 in mm3
Serum platlet >50000 in mm3
Serum Cratinin< 1.5 mg/d
BUN<25 in dl
Serum potassium 3.5-5 mmol/L
Get informed consent
Exclusion criteria:
ُSever mental or physical illness disturbing treatment according protocole
Previous brain radiotherapy or radiosurgery
Patients wihtout regular follow-up
Age<18 &>90 years
Previous treatment with ACEI/ARB drugs
Pregnancy
Baseline hypotenssion
Leptomeningeal involvment
Age
From 18 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals randomly divided to two groups based on fourth permutation blocks, so that reasercher do not interfere with the allocation of treatment methods to patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in study which are patients with brain metastasis, after being informed about attending in a clinical study and obtaining consent, are unaware that they are taking Losartan pill in addition to standard radiotherapy or placebo. The researcher and the evaluator of outcome is also unaware which groups is taking drug and which group taking placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundi shapour University of Medical sciences
Street address
Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6136964695
Approval date
2016-11-19, 1395/08/29
Ethics committee reference number
IR.AJUMS.REC.1395.588
Health conditions studied
1
Description of health condition studied
Brain metastasis
ICD-10 code
C71
ICD-10 code description
Malignant neoplasm of brain
Primary outcomes
1
Description
Radiologic response of brain metastatic lesion
Timepoint
6 weeks after ending of intervention
Method of measurement
RECIST V1.1criteria for response evaluation in solid tumors
Secondary outcomes
1
Description
Radiologic response of non target metastatic brain lesion
Timepoint
6 weeks after ending intervention
Method of measurement
RECIST v 1.1 criteria for response evaluation in solid tumors
Intervention groups
1
Description
Intervention group: whole brain radiation with 30 Gray in 10 fractions and using 25 mg losartan tablet during radition course
Category
Treatment - Drugs
2
Description
Control group: standard treatment with whole brain radiation with 30 Gray in 10 fractions and using placebo during radiation course
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan hospital
Full name of responsible person
Yasamin Mahouram
Street address
Nomber 20, Day street, Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6136964695
Phone
+98 61 3321 9277
Email
mahouram.yasamin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundi Shapour university of Medical Science
Full name of responsible person
Dr Behzad Sharif Makhmalzade
Street address
Ahvaz, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6136964695
Phone
+98 61 3374 5533
Email
mahouram.yasamin@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundi Shapour university of Medical Science
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
Ahvaz Jundishapour University Of Medical Science
Full name of responsible person
Yasamin Mahouram
Position
Radiothrapy & Oncology assistant
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
No 20, day street, Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6136964695
Phone
+98 61 3321 9277
Fax
Email
mahouram.y@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapour University Of Medical Science
Full name of responsible person
Seyed Mohammad Hosseini
Position
Assistant professor of radiothrapy & oncology
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
No 9, 5th street, Kianpars, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135763491
Phone
+98 61 3337 3057
Fax
Email
hosseini.mohamad@ajums.ac.ar
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapour University Of Medical Science
Full name of responsible person
Yasamin Mahouram
Position
Radiothrapy & Oncology assistant
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
NO 20, Day Street, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6136964695
Phone
+98 61 3321 9277
Fax
Email
mahouram.y@ajums.ac.ir
Web page address
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
Participants' demographic information and informed consent form after unidentifiable individuals,also the study protocol include prescribed radiation dose and drug dose and statistical analysis result will be shared.
When the data will become available and for how long
Start the access preiod,one year after the result are printed.
To whom data/document is available
Data will be available to researchers at university colleges.
Under which criteria data/document could be used
Unidentifiable individual data and analysis result after confirmation of applicants' membreship in academic research center,are presented to them.
From where data/document is obtainable
Applicants can submit a request for access by email at the following email address:
mahouram.yasamin@gmail.com
Mobile phone NO:09166110130
Yasamin mahouram, Golestan hospital,golestan blvd,Ahvaz
What processes are involved for a request to access data/document
The applicant,after submitting a request for access to any releasable data, must send a confirmation of his membership in one of the academic research center and the organization position.the data will be provided to them within maximum one month of receipt of request.