Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma

NCT05439278 | Recruiting Phase 3

• 1 other identifier: KROG 21-11
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

  from randomization

  follow-up until 2 years

Secondary Outcomes (3)

• progression-free survival

  follow-up until 2 years

• treatment-related toxicity

  follow-up until 2 years

• patient-reported quality of life

  follow-up until 2 years

Study Arms (2)

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)

Radiation: Hypofractionated radiotherapy; Drug: Temozolomide

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)

Radiation: Conventional radiotherapy; Drug: Temozolomide

Interventions

Hypofractionated radiotherapy RADIATION

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

Hypofractionated radiochemotherapy

Conventional radiotherapy RADIATION

60 Gy in 30 fractions (daily treatment, 5 per week)

Conventional radiochemotherapy

Temozolomide DRUG

concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)

Conventional radiochemotherapy; Hypofractionated radiochemotherapy

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Severance Hospital: lead

Study Sites (1)

Severance hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

Radiation Dose Hypofractionation; Temozolomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Chan Woo Wee, MD, PhD

  Severance Hospital

  STUDY CHAIR

• In Ah Kim, MD, PhD

  Seoul National University Bundang Hospital

  STUDY CHAIR

Central Study Contacts

Chan Woo Wee, MD, PhD

CONTACT

+82-2-2228-8121; wcw0108@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, PhD

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 30, 2022
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)