A RANDOMIZED PHASE III STUDY OF TEMOZOLOMIDE AND SHORT-COURSE RADIATION VERSUS SHORT-COURSE RADIATION ALONE IN THE TREATMENT OF NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME IN ELDERLY PATIENTS

A RANDOMIZED PHASE III STUDY OF TEMOZOLOMIDE AND SHORT-COURSE RADIATION VERSUS SHORT-COURSE RADIATION ALONE IN THE TREATMENT OF NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME IN ELDERLY PATIENTS - A RANDOMIZED PHASE III STUDY OF TEMOZOLOMIDE AND SHORT-COURSE RADIATION VERSUS SHORT-COURSE RADIATION ALONE IN THE TREATMENT OF NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME IN ELDERLY PATIENTS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002434

Enrollment

560

Registered

2010-01-01

Start date

2009-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma

Interventions

radiotherapy temozolomide

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histopathologically confirmed newly diagnosed glioblastoma multiforme Patient's age is > 65 years.

Exclusion criteria

Exclusion criteria: Patients with a history of other malignancies. Patients with a serious active infection at the time of randomization or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment. Patients with any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol. Patients with known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide. Patients who have had treatment with any investigational cancer drug prior to randomization.

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
Progression-free survival Adverse events Quality of life	—

Countries

Japan,North America,Australia,Europe

Contacts

Public ContactRyo Nishikawa

International Medical Center, Saitama Medical University Department of Neuro-Oncology

rnishika@saitama-med.ac.jp042-984-4111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026