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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated radiochemotherapy | Experimental | Radiotherapy: 40.05 Gy in 15 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles) |
|
| Conventional radiochemotherapy | Experimental | Radiotherapy: 60 Gy in 30 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated radiotherapy | Radiation | 40.05 Gy in 15 fractions (daily treatment, 5 per week) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | from randomization | follow-up until 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | from randomization | follow-up until 2 years |
| treatment-related toxicity | any treatment-related toxicity | follow-up until 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chan Woo Wee, MD, PhD | Contact | +82-2-2228-8121 | wcw0108@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Chan Woo Wee, MD, PhD | Severance Hospital | Study Chair |
| In Ah Kim, MD, PhD | Seoul National University Bundang Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance hospital | Recruiting | Seoul | South Korea |
There is no plan to make individual participant data available.
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Conventional radiotherapy | Radiation | 60 Gy in 30 fractions (daily treatment, 5 per week) |
|
| Temozolomide | Drug | concurrent (75 mg/m2/day qd) and adjuvant (6 cycles) |
|
| 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 | follow-up until 2 years |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D003606 |
| Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |