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Study aim:
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