In newly diagnosed glioblastoma patients aged 70 years or older who are suitable for concurrent temozolomide, the optimal dose of radiation therapy is controversial . The purpose of this study is to compare conventional radiotherapy of 60 Gy (6 weeks) versus hypofractionated radiotherapy of 40 Gy (3 weeks) in terms of overall survival as the primary endpoint along with progression-free survival, toxicity, quality of life, and prognostic biomarkers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
178
40.05 Gy in 15 fractions (daily treatment, 5 per week)
60 Gy in 30 fractions (daily treatment, 5 per week)
concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
Severance hospital
Seoul, South Korea
RECRUITINGOverall survival
from randomization
Time frame: follow-up until 2 years
progression-free survival
from randomization
Time frame: follow-up until 2 years
treatment-related toxicity
any treatment-related toxicity
Time frame: follow-up until 2 years
patient-reported quality of life
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 version 3.0): range, 0-100 (a high score for a functional scale represents a high / healthy level of functioning; a high score for the global health status / QoL represents a high QoL; a high score for a symptom scale / item represents a high level of symptomatology / problems) Quality of Life Questionnaire-Brain Neoplasm (EORTC QLQ-BN20): range, 20-80; lower score means better outcome
Time frame: follow-up until 2 years
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