Radiologic Response to Conventional Whole Brain Radiation Therapy plus Concurrent Intravenous Infusion of Sodium Nitrite versus Radiation Therapy Alone In Patients with Brain Metastases
This randomized, single-blind clinical trial intends to evaluate the radiobiological properties of sodium nitrite as a nitric oxide supply in radiation therapy. Therefore, patients suffered from brain metastasis randomly assign into two intervention groups. In the first intervention group, patients are treated with whole brain radiation therapy (WBRT) alone (30 Gy in 10 fractions using opposed parallel 6MV photon beams). In the second intervention group, patients will receive WBRT as the first group, and concomitant two hour intravenous (IV) infusion of sodium nitrite (267 microgram/kilogram/hour) before each fraction of radiation. For evaluation of the effects of this agent, as a radio sensitizer, and measurement of radiologic response rate, magnetic resonance scans (MRI) (T1 sequence plus IV contrast) of patients, before and one month after completion of treatment will be compared based on the extent of the metastases and according to response evaluation criteria in solid tumors (RECIST v1.1). Then patients will be classified into four groups including complete responders, partial responders, progressive and stable disease. Finally radiologic response rate in the two arms of this trial will be analyzed using statistical tests.
General information
Acronym
NORS - Nitric Oxide as a Radio Sensitizer
IRCT registration information
IRCT registration number:IRCT2013101515026N1
Registration date:2013-10-25, 1392/08/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-10-25, 1392/08/03
Registrant information
Name
Ali Bagheri
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 0236
Email address
bagheri-a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2013-10-02, 1392/07/10
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Radiologic Response to Conventional Whole Brain Radiation Therapy plus Concurrent Intravenous Infusion of Sodium Nitrite versus Radiation Therapy Alone In Patients with Brain Metastases
Public title
Sodium nitrite radio biological properties as a radio sensitizer
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical sciences
Street address
Golestan Ave.
City
Ahvaz
Postal code
61357-15794
Approval date
2013-09-29, 1392/07/07
Ethics committee reference number
2295//د/8/20/پ
Health conditions studied
1
Description of health condition studied
Brain metastasis
ICD-10 code
C79.3
ICD-10 code description
Secondary malignant neoplasm of brain and cerebral meninges
Primary outcomes
1
Description
Radiologic response
Timepoint
One month after completion of intervention
Method of measurement
According to response evaluation criteria in solid tumors version 1.1 (RECIST)
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Treatment - Other
2
Description
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
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital, Radiotherapy & Oncology Center
Full name of responsible person
Seyed Mohammad hosseini, Radiation Oncologist
Street address
Golestan Ave.
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical sciences
Full name of responsible person
Mohammad reza abbaspour
Street address
Golestan Ave.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical sciences
Full name of responsible person
Ali Bagheri
Position
Resident Physician in Radiation Oncology
Other areas of specialty/work
Street address
Golestan Ave., Golestan Hospital, Radiotherapy & Oncology Center
City
Ahvaz
Postal code
Phone
+98 61 1374 0236
Fax
Email
alibagheri.md@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical sciences
Full name of responsible person
Ali Bagheri
Position
Resident Physician in Radiation Oncology
Other areas of specialty/work
Street address
Golestan ave.
City
Ahvaz
Postal code
Phone
+98 61 1374 0236
Fax
Email
alibagheri.md@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical sciences
Full name of responsible person
Ali Bagheri
Position
Resident Physician in Radiation Oncology
Other areas of specialty/work
Street address
Golestan Ave.
City
Ahvaz
Postal code
Phone
+98 61 1374 0236
Fax
Email
alibagheri.md@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)