Studying the effect of timing (chronotherapy) of temozlamide concomitant with radiotherapy and adjuvant on the response rate to treatment in patients with high-grade goli referred to Shohada Tajrish and Salamat Farda hospitals in 1404-1405
Design
Randomized clinical trial, phase 1, on 60 patients, which is a random number table contrast tool
Settings and conduct
In Shohada Tajrish and Salamat Farda Hospital, all the necessary data are collected and recorded according to the history taking of physical examination and tests and MRI and are finally analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: over 18 years of age with newly diagnosed grade gliomas according to the pathology report (IDH wildetype, TERT promoter mut., EGFR amp. or PTEN deletion), KPS greater than or equal to 60% and good cooperation. Pregnant and breast feeding and not cooperative patient excluded from the study
Intervention groups
Patients are randomly divided into two groups 1:1, in the first group (morning group) temozolamide is taken 1 hour before radiotherapy and before 12 am, and in the second group (evening group) temozolamide is taken 1 hour before radiotherapy and after It will be 6pm
AM (Taking temozolamide before 12:00 AM, either simultaneously with radiotherapy (with an interval of 1 hour before radiotherapy) or as an adjuvant)
Category
Treatment - Other
2
Description
PM (Taking temozolamide after 6 pm, either simultaneously with radiotherapy (with an interval of 1 hour before radiotherapy) or as an adjuvant)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tajrish Martyrs Hospital, Salamat Farda Hospital
Full name of responsible person
Fatemeh Salari
Street address
shahrdari ave, qods square, tehran town
City
tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr-shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Aarabi Ave, Shahid Chamran Blvd, tehran town
City
tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Salari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Shahrdari Ave, ghods square, Tehran Town
City
tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
f.salari1996@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Salari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Shahrdari Ave, ghods square, Tehran Town
City
tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
f.salari1996@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Salari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Shahrdari Ave, ghods square, Tehran Town
City
tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
f.salari1996@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All participant data can be shared after de-identifying individuals.
When the data will become available and for how long
Access period starts 6 months after results are published.
To whom data/document is available
It will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Access is open for research purposes.
From where data/document is obtainable
Correspondence via email f.salari1996@gmail.com
What processes are involved for a request to access data/document
After submitting the request and clarifying the applicant's intentions, if for research purposes, the information will be provided to the applicant via email, while maintaining ethical standards.