Brain metastasis. Secondary malignant neoplasm of brain and cerebral meninges
Conditions
Interventions
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,
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
Sponsors
Ahvaz Jundishapur University of Medical sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiologic response. Timepoint: One month after completion of intervention. Method of measurement: According to response evaluation criteria in solid tumors version 1.1 (RECIST). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Bagheri
Ahvaz Jundishapur University of Medical sciences
Outcome results
None listed