Comparison of treatment outcomes and failure pattern in high grade glioma treated with adjuvant radiotherapy based on standard protocol of RTOG versus smaller margin
Comparison of recurrence pattern and treatment outcomes in patients with high-grade glioma managed by adjuvant radiotherapy based on standard protocol of RTOG with treatment by smaller margin.
Design
A randomized phase 3 clinical trial ,with single-blinded outcome assessment, with a parallel group design of 192 patients . randomization will carry out with block randomization.
Settings and conduct
This study will be done as a multicenter trial in Mashhad ,Tehran, Babol and Sabzevar cities. Patients participating in this trial will be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Newly diagnosed patients with glioblastoma and anaplastic astrocytoma and oligodendroglioma who have pathology evidence
Age 18-75 years
KPS≥70%
Exclusion criteria:
Uncontrolled comorbidities such as diabetes or hypertension that make radiotherapy and chemotherapy infeasible
Impossibility of surgery and sampling
Intervention groups
Patients in the intervention group will undergo radiotherapy to the lesion (46 gray dose in 23 fractions to a margin of 1 cm to the high signal region in the , T2/ FLAIR sequences in MRI (residual tumor plus tumor bed removed plus surrounding edema) and boost dose to total of 60 gray to a 1cm margin to the enhancive lesion in the T1 weighted MRI (residual tumor) and tumor bed.
Patients in the control group (Based on the RTOG protocol)will undergo radiotherapy to the lesion (46 gray dose in 23 fractions to a margin of 2 cm to the high signal region in the T2/ FLAIR sequences in MRI (residual tumor plus tumor bed removed plus surrounding edema) and boost dose to total of 60 gray to a 2cm margin to the enhancive lesion in the T1 weighted MRI (residual tumor) and tumor bed.
Main outcome variables
Overall survival
Progression free survival
Pattern of failure
General information
Reason for update
Acronym
MRRG
IRCT registration information
IRCT registration number:IRCT20210215050367N1
Registration date:2021-03-19, 1399/12/29
Registration timing:prospective
Last update:2021-03-19, 1399/12/29
Update count:0
Registration date
2021-03-19, 1399/12/29
Registrant information
Name
parisa rabiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3842 6082
Email address
rabieep971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of treatment outcomes and failure pattern in high grade glioma treated with adjuvant radiotherapy based on standard protocol of RTOG versus smaller margin
Public title
Margin reduction in radiotherapy of high grade glioma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Newly diagnosed glioblastoma multiform patients
Newly diagnosed anaplastic astrocytoma patients
Newly diagnosed oligodendroglioma patients
Confirmed diagnosis based on pathologic evaluation
Karnofsky performance index more than 70%
Exclusion criteria:
Uncontrolled diabetes
Uncontrolled high blood pressure
Impossibility of surgery and tissue sampling
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
192
Randomization (investigator's opinion)
Randomized
Randomization description
Using the www.sealedenvelope.com website, a block randomization list with block size of 4 (2:2), including group A ( intervention ) and group B ( control) will be created. In this context, numbers will be arranged into AABB, BBAA, ABAB, BABA blocks based on the sequence generated by the site and participants will be enrolled into each group randomly.
Blinding (investigator's opinion)
Single blinded
Blinding description
At time of entry to trial and obtaining informed consent, patients will be informed that they may be either in control or intervention group and they will be blind about their treatment group. In this context, the patient will not aware the amount margins on the treatment planning, however, since the corresponding physician is responsible for treatment planning, his/her blandness will bee impossible. Therefore, this study will be conducted in a single blinded fashion.
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
At the beginning of the study and then every 3 months in the first year and every 6 months in the following years.
Method of measurement
Physical exam and MRI
Secondary outcomes
1
Description
overall survival
Timepoint
Every 3 month in the first year and every 6 month in subsequent years
Method of measurement
Physical exam and MRI
2
Description
Pattern of failure
Timepoint
Every 3 month in the first year and every 6 month in subsequent years.
Method of measurement
Physical exam and MRI
Intervention groups
1
Description
Intervention group: intervention group will undergo radiotherapy to the lesion (46 gray dose in 23 fractions to a margin of 1 cm to the high signal region in the , T2/ FLAIR sequences in MRI (residual tumor plus tumor bed removed plus surrounding edema) and boost dose to total of 60 gray to a 1cm margin to the enhancive lesion in the T1 weighted MRI (residual tumor) and tumor bed.
Category
Treatment - Other
2
Description
Control group: Patients in the control group (Based on the RTOG protocol)will undergo radiotherapy to the lesion (46 gray dose in 23 fractions to a margin of 2 cm to the high signal region in the T2/ FLAIR sequences in MRI (residual tumor plus tumor bed removed plus surrounding edema) and boost dose to total of 60 gray to a 2cm margin to the enhancive lesion in the T1 weighted MRI (residual tumor) and tumor bed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Parisa Rabiei
Street address
Emamreza Sq., Ebn-e-sina Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
emamreza@mums.ac.ir
2
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Parisa Rabiei
Street address
Alandasht crossroad, Koohsangi Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3842 6082
Email
omidhos@mums.ac.ir
3
Recruitment center
Name of recruitment center
Vasei Hospital
Full name of responsible person
Seyed Alireza Javadinia
Street address
Tohid Shahr Blvd.
City
Sabzevar
Province
South Khorasan
Postal code
9617747431
Phone
+98 51 4465 1300
Fax
Email
vasei.h@medsab.ac.ir
4
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Mostafa Farzin
Street address
Dr Gharib Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
imamhospital@tums.ac.ir
5
Recruitment center
Name of recruitment center
Shahid Rajaei Hospital
Full name of responsible person
Danial Fazilatpanah
Street address
Shariati Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3528 9259
Fax
+98 11 3528 9262
Email
rajaee@mubabol.ac.ir
6
Recruitment center
Name of recruitment center
Reza Radiotherapy & Oncology Center
Full name of responsible person
Kazem Anvari
Street address
Rafsanjani 19 ,17th Azar square , Shahrak Gharb
City
Mashhad
Province
Razavi Khorasan
Postal code
9184166759
Phone
+98 51 3500 8715
Email
Info@rroc.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@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
Parisa Rabiei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
oncology
Street address
Omid hospital, Alanandasht Crossroad,Kuhsangi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3842 6082
Email
rabieep971@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Kazem Anvari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
oncology
Street address
Omid hospital, Aalndasht Crossroad, Kuhsangi Street