Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05439278
• Other study ID #: KROG 21-11
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 1, 2022
• Est. completion date: July 31, 2027

Study information

• Verified date: June 2022
• Source: Seoul National University Boramae Hospital
• Contact: Chan Woo Wee, MD, PhD
• Phone: +82-2-870-1695
• Email: wcw0108[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 268
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Radiation:
• Hypofractionated radiotherapy
40.05 Gy in 15 fractions (daily treatment, 5 per week)
• Conventional radiotherapy
60 Gy in 30 fractions (daily treatment, 5 per week)

Drug:
• Temozolomide
concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Boramae Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	from randomization	follow-up until 2 years
Secondary	progression-free survival	from randomization	follow-up until 2 years
Secondary	treatment-related toxicity	any treatment-related toxicity	follow-up until 2 years
Secondary	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