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IRCT20210215050367N1 IRCT 2021-03-19 Mashhad University of Medical Sciences Margin reduction in radiotherapy of high grade glioma MRRG Comparison of treatment outcomes and failure pattern in high grade glioma treated with adjuvant radiotherapy based on standard protocol of RTOG versus smaller margin 2021-04-04 anticipated 192 Complete https://irct.ir/trial/54361 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 High grade glioma. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Study protocol, patients data (without identity information) and analysis data will be shared. When: After the publication of article To whom: Researchers and physicians Conditions: After sending an official request to the corresponding person (Dr Anvari) Where to obtain: Through email communication How to obtain: After receiving the request through email, Dr Anavri will send the requested data. Comments:
public Parisa Rabiei
Omid hospital, Alanandasht Crossroad,Kuhsangi Street
Mashhad Iran (Islamic Republic of) 9176613775 +98 51 3842 6082 rabieep971@mums.ac.ir Mashhad University of Medical Sciences scientific Kazem Anvari
Omid hospital, Aalndasht Crossroad, Kuhsangi Street
Madshhad Iran (Islamic Republic of) 9176613775 +98 51 3842 6082 anvarik@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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% 18 years 75 years Both Uncontrolled diabetes Uncontrolled high blood pressure Impossibility of surgery and tissue sampling C71 Malignant neoplasm of brain Treatment - Other Treatment - Other 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. 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. Progression free survival. Timepoint: 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. Overall survival. Timepoint: Every 3 month in the first year and every 6 month in subsequent years. Method of measurement: Physical exam and MRI. 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. Mashhad University of Medical Sciences Approved 2020-11-30 Ethics committee of Mashhad University of Medical Sciences Omid hospital, Alandasht crossroad ,Koohsangi avenue Mashhad Razavi Khorasan Iran (Islamic Republic of)