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Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma

Phase 3
Not yet recruiting
Conditions
Glioblastoma
Interventions
Radiation: Hypofractionated radiotherapy
Radiation: Conventional radiotherapy
Drug: Temozolomide
Registration Number
NCT05439278
Lead Sponsor
Seoul National University Boramae Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
268
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Hypofractionated radiochemotherapyHypofractionated radiotherapyRadiotherapy: 40.05 Gy in 15 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
Conventional radiochemotherapyConventional radiotherapyRadiotherapy: 60 Gy in 30 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
Hypofractionated radiochemotherapyTemozolomideRadiotherapy: 40.05 Gy in 15 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
Conventional radiochemotherapyTemozolomideRadiotherapy: 60 Gy in 30 fractions (daily treatment, 5 per week) Temozolomide: concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)
Primary Outcome Measures
NameTimeMethod
Overall survivalfollow-up until 2 years

from randomization

Secondary Outcome Measures
NameTimeMethod
progression-free survivalfollow-up until 2 years

from randomization

patient-reported quality of lifefollow-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

treatment-related toxicityfollow-up until 2 years

any treatment-related toxicity

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