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IRCT20170314033080N2 IRCT 2018-03-11 Ahvaz Jundi Shapour university of Medical Science Effect of losartan with whole bain radiotherapy in brain metastasis Radiologic response evaloution after conventional whole brain radiation therapy plus concurrent oral adminestration of losartan versus radiotion therapy alone in patients with brain metastasis 2018-03-21 anticipated 60 Complete https://irct.ir/trial/25613 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 2 Brain metastasis. Intervention 1: Intervention group: whole brain radiation with 30 Gray in 10 fractions and using 25 mg losartan tablet during radition course. Intervention 2: Control group: standard treatment with whole brain radiation with 30 Gray in 10 fractions and using placebo during radiation course. Yes - There is a plan to make this available What will be shared: 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: Start the access preiod,one year after the result are printed. To whom: Data will be available to researchers at university colleges. Conditions: Unidentifiable individual data and analysis result after confirmation of applicants' membreship in academic research center,are presented to them. Where to obtain: 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 How to obtain: 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. Comments:
public Yasamin Mahouram
No 20, day street, Golestan, Ahvaz
Ahvaz Iran (Islamic Republic of) 6136964695 +98 61 3321 9277 mahouram.y@ajums.ac.ir Ahvaz Jundishapour University Of Medical Science scientific Seyed Mohammad Hosseini
No 9, 5th street, Kianpars, Ahvaz
Ahvaz Iran (Islamic Republic of) 6135763491 +98 61 3337 3057 hosseini.mohamad@ajums.ac.ar Ahvaz Jundishapour University Of Medical Science Iran (Islamic Republic of) 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 18 years 90 years Both ُ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 C71 Malignant neoplasm of brain Treatment - Drugs Placebo Intervention group: whole brain radiation with 30 Gray in 10 fractions and using 25 mg losartan tablet during radition course Control group: standard treatment with whole brain radiation with 30 Gray in 10 fractions and using placebo during radiation course 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. 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. Ahvaz Jundi Shapour university of Medical Science Approved 2016-11-19 Ethics committee of Ahvaz Jundi shapour University of Medical sciences Golestan, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)