A single-blind, randomized, clinical trial comparing the efficacy of 6 cycles versus 12 cycles temozolomide regimens in adjuvant treatment of patients with brain malignant astrocytoma
Comparison of overall survival and progression free survival between 6 cycles and 12 cycles adjuvant Temozolomide regimens in patients with brain glioblastoma and anaplastic astrocytoma
Design
This is a phase III, non-blinded, blocked randomized clinical trial. The study is conducted on 62 newly diagnosed patients with brain glioblastoma multiforme and anaplastic astrocytoma referring to the oncology clinics during March 2018 and March 2019. The patients will be randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1).
Settings and conduct
This study will be conducted in the oncology clinic of Omid Hospital and Imam Reza Hospital, Mashhad. Blinding is not observed in this study.
Participants/Inclusion and exclusion criteria
The main inclusion criterion includes patients newly diagnosed with glioblastoma and anaplastic astrocytoma whose diagnosis is confirmed by histologic evaluation. The main exclusion criteria involve chronic renal, hepatic or cardiac failure.
Intervention groups
The patients will initially undergo surgery. Within 4 to 6 weeks after surgery, all patients will receive chemoradiation. After completion of chemoradiation, the cases will receive 12 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meter body surface per day for the first 5 days of every 28 days). In the control group, the patients will receive 6 cycles of adjuvant Temozolomide (in the same dosage).
Main outcome variables
The primary endpoints of study are overall survival and progression free survival.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160706028815N3
Registration date:2018-03-14, 1396/12/23
Registration timing:prospective
Last update:2018-03-14, 1396/12/23
Update count:0
Registration date
2018-03-14, 1396/12/23
Registrant information
Name
Seyed Alireza Javadinia
Name of organization / entity
Department of Oncology, Omid Hospital, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2736
Email address
javadiniaa941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A single-blind, randomized, clinical trial comparing the efficacy of 6 cycles versus 12 cycles temozolomide regimens in adjuvant treatment of patients with brain malignant astrocytoma
Public title
Efficacy of two temozolomide regimens in adjuvant treatment of patients with brain malignant astrocytoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Newly diagnosed glioblastoma and anaplastic astrocytoma
age between 18 and 70 years
Karnofsky Performance Scale Index equal or more than 60 percent
signed informed consent
Exclusion criteria:
chronic hepatic, renal or cardiac failure
history of hematologic malignancies
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
The participants are assigned into the two intervention groups using permuted block randomization method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138735499
Approval date
2017-11-01, 1396/08/10
Ethics committee reference number
IR.MUMS.fm.REC.1396.449
Health conditions studied
1
Description of health condition studied
brain malignant astrocytoma
ICD-10 code
C71
ICD-10 code description
Malignant neoplasm of brain
Primary outcomes
1
Description
Overall survival
Timepoint
One year after the treatment is completed
Method of measurement
Patient follow-up
2
Description
Progression-free survival
Timepoint
12 months after the treatment is completed
Method of measurement
brain imaging and physical examination
Secondary outcomes
1
Description
Anemia
Timepoint
Before each session of monthly chemotherapy
Method of measurement
laboratory assessment of complete blood count
2
Description
Neutropenia
Timepoint
Before each session of monthly chemotherapy
Method of measurement
laboratory assessment of complete blood count
3
Description
Thrombocytopenia
Timepoint
Before each session of monthly chemotherapy
Method of measurement
laboratory assessment of complete blood count
4
Description
Alopecia
Timepoint
Before each session of monthly chemotherapy
Method of measurement
physical examination
5
Description
Nausea
Timepoint
Before each session of monthly chemotherapy
Method of measurement
history taking
6
Description
vomiting
Timepoint
Before each session of monthly chemotherapy
Method of measurement
history taking
Intervention groups
1
Description
Intervention group 1 (12-cycle): After completion of chemoradiation, the cases will receive 12 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meters body surface per day for the first 5 days of every 28 days).
Category
Treatment - Drugs
2
Description
Intervention group 2 (6 cycles): After completion of chemoradiation, the participants will receive 6 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meters body surface per day for the first 5 days of every 28 days).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Oncology Clinic of Omid Hospital
Full name of responsible person
Dr Kazem Anvari
Street address
Koohsangi Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3842 6936
Email
AnvariK@mums.ac.ir
2
Recruitment center
Name of recruitment center
Oncology Clinic of Imam Reza Hospital
Full name of responsible person
Dr Kazem Anvari
Street address
Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3842 6936
Email
AnvariK@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 8384 1538
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Saghafi
Position
Assistant of Radiooncology
Latest degree
Medical doctor
Other areas of specialty/work
Hematology
Street address
Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3842 6936
Email
SaghafiMR951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Kazem Anvari
Position
Oncologist
Latest degree
Specialist
Other areas of specialty/work
Hematology
Street address
Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3842 6936
Email
AnvariK@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
Translator
Latest degree
Master
Other areas of specialty/work
Others
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5680
Email
hadirooz@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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Deidentified Individual Participant Data Set
When the data will become available and for how long
When the study completes and for 6 months
To whom data/document is available
academic researchers
Under which criteria data/document could be used
No other criteria
From where data/document is obtainable
In the study website: http:// yon.ir/xzDIR
What processes are involved for a request to access data/document
registration on the study website and delivery of request