The average survival rate for patients with Glioblastoma Multiform is about 12 months, so this study is designed to find a new treatment for these patients. It has been shown that metformin has some antitumoral effect. The study population is the patients with GBM aged 18 and above in both genders with KPS 60 and more into intervention and control groups each one consisted of 30 patients. The patients in intervention group will receive radiotherapy, temozolamide and metformin and the patients in control group will receive radiotherapy, temozolamide and placebo.the survival and progression free survival will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112725256N1
Registration date:2016-08-04, 1395/05/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-04, 1395/05/14
Registrant information
Name
Hossein Eskandary
Name of organization / entity
kerman University of Medical Sciencses
Country
Iran (Islamic Republic of)
Phone
+98 913 341 5316
Email address
s.karamouzian@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman Neuroscience Institute
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Metformin plus Temozolamide on Patients with Glioblastoma Multiform
Public title
Effect of Metformin on Glioblastoma Multiform
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion: GBM diagnosis confirmed by pathology; age>18; KPS>60; normal kidney function
exclusion:; no underlining disease which interfere the course of treatment
a life threatening diseases other than GBM; DM; infectious disease
; lactation or pregnancy
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Kerman Neuroscience Institute
Street address
Somaie Crossroad in front of Besat Clinic
City
Kerman
Postal code
Approval date
2016-02-18, 1394/11/29
Ethics committee reference number
ir.kmu.rec.1394..371
Health conditions studied
1
Description of health condition studied
Glioblastom multiform
ICD-10 code
C71.9
ICD-10 code description
Brain, unspecified
Primary outcomes
1
Description
overall survival
Timepoint
monthly
Method of measurement
alive or dead
Secondary outcomes
1
Description
progression free survival
Timepoint
based on clinical deterioration
Method of measurement
deterioration of KPS of appearance of new lesion
Intervention groups
1
Description
Intervention Group will receive radiotherapy plus Temozolomide and Metformin 1g daily. The patients should take Metformin durng radiotherapy and after that till primay endpoint.
Category
Treatment - Drugs
2
Description
Control Group will receive radiotherapy and Temozolomide as routine adjuvant treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahonar Hospital
Full name of responsible person
Street address
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman Neuroscience Research Center
Full name of responsible person
ٰVahid Sheibani
Street address
Somayeh Cross- In Front of Besat Clinic
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman Neuroscience Research Center
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
Kerman Neuroscience Research Center
Full name of responsible person
Hossein Eskandary
Position
Professor
Other areas of specialty/work
Street address
Kerman
City
Kerman
Postal code
Phone
+98 34 3223 5011
Fax
Email
eskandary52@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman Neuroscience Research Center
Full name of responsible person
Hossein Eskandry
Position
Professor
Other areas of specialty/work
Street address
Kerman
City
Kerman
Postal code
Phone
+98 34 3223 5011
Fax
Email
eskandary52@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman Neuroscience Research Center
Full name of responsible person
Saeid Karamouzian
Position
Associated Professor
Other areas of specialty/work
Street address
Bahonar Hospital, Gharaney Street
City
Kerman
Postal code
6777617513
Phone
+98 34 1226 4196
Fax
+98 34 1226 4198
Email
karamouzian@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)