Glioblastoma
Conditions
Brief summary
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.
Interventions
RADIATIONHypofractionated radiotherapy
40.05 Gy in 15 fractions (daily treatment, 5 per week)
RADIATIONConventional radiotherapy
60 Gy in 30 fractions (daily treatment, 5 per week)
DRUGTemozolomide
concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
Sponsors
Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* newly diagnosed glioblastoma according to the 2021 World Health Organization classification * interval of ≤4 weeks between pathological diagnosis and randomization * aged 70 years or older * gadolinium-enhanced MRI within 72 hours of surgery * known o6-methylguanine-DNA-methyltransferase promoter methylation status * Karnofsky performance score ≥60 * stable or decreasing dose of steroid (if necessary) * no history of brain radiotherapy * no history of any systemic chemotherapy * adequate hematological, renal and hepatic functions for temozolomide * able to start radiotherapy within 3 weeks from randomization
Exclusion criteria
* patients with spinal leptomeningeal carcinomatosis * history of cancer other than the followings: * carcinoma in situ of the cervix * completely excised non-melanoma skin cancer * cancers without any evidence of residual disease for 5 years or longer * patients with serious active infection or other serious underlying medical conditions * patients with psychological issues that cannot comply to the protocol * patients with known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide * patients who are currently participating in other clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | follow-up until 2 years | from randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival | follow-up until 2 years | from randomization |
| treatment-related toxicity | follow-up until 2 years | any treatment-related toxicity |
| patient-reported quality of life | follow-up until 2 years | 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 |
Countries
South Korea
Contacts
Primary ContactChan Woo Wee, MD, PhD
Outcome results
None listed