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IRCT2013101515026N1 IRCT 2013-10-25 Ahvaz Jundishapur University of Medical sciences Sodium nitrite radio biological properties as a radio sensitizer NORS - Nitric Oxide as a Radio Sensitizer Radiologic Response to Conventional Whole Brain Radiation Therapy plus Concurrent Intravenous Infusion of Sodium Nitrite versus Radiation Therapy Alone In Patients with Brain Metastases 2013-10-02 anticipated 70 Complete https://irct.ir/trial/14449 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 Brain metastasis. Intervention 1: Whole brain radiation therapy, both arms of the trial, parallel opposed 6MV photon beams, total dose 30 Gy in 10 fractions, 5 days a week, for 2 weeks. Intervention 2: Sodium nitrite, 2 hour intravenous infusion, 267 microgram per kilogram per hour of 3% solution diluted in half liter of normal saline before each fraction of radiation.
public Ali Bagheri
Golestan Ave., Golestan Hospital, Radiotherapy & Oncology Center
Ahvaz Iran (Islamic Republic of) +98 61 1374 0236 alibagheri.md@gmail.com Ahvaz Jundishapur University of Medical sciences scientific Ali Bagheri
Golestan ave.
Ahvaz Iran (Islamic Republic of) +98 61 1374 0236 alibagheri.md@gmail.com Ahvaz Jundishapur University of Medical sciences Iran (Islamic Republic of) Inclusion criteria: 1. Histopathologically confirmed extra cranial malignancy. 2. At least one brain metastasis >= 1 cm in size demonstrated on a gadolinium enhanced T1 sequence MRI scan.3. Patients must have an estimated survival of at least 4 weeks. 4. ECOG performance status of 0-3. Exclusion criteria: 1. Major medical illnesses or psychiatric impairments which, in the investigator's opinion, will prevent completion of the protocol therapy.2. Previous radiotherapy to the head. 3. Patients who cannot be regularly followed. 4. Leptomeningeal involvement 18 years 80 years Both C79.3 Secondary malignant neoplasm of brain and cerebral meninges Treatment - Other Treatment - Drugs Whole brain radiation therapy, both arms of the trial, parallel opposed 6MV photon beams, total dose 30 Gy in 10 fractions, 5 days a week, for 2 weeks Sodium nitrite, 2 hour intravenous infusion, 267 microgram per kilogram per hour of 3% solution diluted in half liter of normal saline before each fraction of radiation Radiologic response. Timepoint: One month after completion of intervention. Method of measurement: According to response evaluation criteria in solid tumors version 1.1 (RECIST). Ahvaz Jundishapur University of Medical sciences Approved 2013-09-29 Ahvaz Jundishapur University of Medical sciences Golestan Ave. Ahvaz Iran (Islamic Republic of)