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NCT Number: NCT05439278

Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma

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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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypofractionated radiotherapy

Radiation

40.05 Gy in 15 fractions (daily treatment, 5 per week)

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)

Primary outcomes

  1. Overall survival

    Time frame: follow-up until 2 years

    from randomization

Secondary outcomes

  1. progression-free survival

    Time frame: follow-up until 2 years

    from randomization

  2. treatment-related toxicity

    Time frame: follow-up until 2 years

    any treatment-related toxicity

  3. patient-reported quality of life

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chan Woo Wee, MD, PhD

CONTACT

[email protected]

+82-2-2228-8121

Sponsors and collaborators

Lead sponsor

Severance Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Jun 30, 2022
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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