Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Phase III Study of Conventional Versus Hypofractionated Radiotherapy Combined With Temozolomide in Elderly Glioblastoma Patients

Conditions
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Glioblastoma

Intervention / Treatment
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* Radiation: Hypofractionated radiotherapy
* Radiation: Conventional radiotherapy
* Drug: Temozolomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypofractionated radiochemotherapy<br>Radiotherapy: 40.05 Gy in 15 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles) | Radiation: Hypofractionated radiotherapy<br>* 40.05 Gy in 15 fractions (daily treatment, 5 per week)<br>Drug: Temozolomide<br>* concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)<br>|
| Experimental: Conventional radiochemotherapy<br>Radiotherapy: 60 Gy in 30 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles) | Radiation: Conventional radiotherapy<br>* 60 Gy in 30 fractions (daily treatment, 5 per week)<br>Drug: Temozolomide<br>* concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | from randomization | follow-up until 2 years | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |