A phase II, multicenter, study for newly diagnosed glioblastomas using boron neutron capture therapy, additional X-ray treatment and chemotherapy

UMIN ID: UMIN000002385

Registered date:01/09/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Newly-diagnosed glioblastoma
• Date of first enrollment: 2009/09/01
• Target sample size: 45
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Protocol treatments consist of BNCT, additional 24 Gy XRT and chemotherapy with TMZ. Prescription dose by BNCT is regulated as not to be more than 13 Gy-Eq for normal brain. Additional XRT is given with 3 gradient such as 8, 16, 24 Gy from the surface of scalp to the bottom of tumor. Chemotherapy with TMZ is applied concomitantly during XRT treatments and adjuvant chemotherapy with the same agent is repeated in outpatient clinic.

Outcome(s)

• Primary Outcome: Overall survival (OS)
• Secondary Outcome: Tumor response Objective Response Rate (ORR) Disease Control Rate (DCR) Adverse event

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Patients who have been treated with chemotherapy or radiotherapy. 2) Female patients in definitive or possible pregnancy or in breast-feeding. 3) Patients with phenylketonuria. 4) Patients with grade III or IV in NYHA classification. 5) Patients with cerebrospinal fluid dissemination. 6) Other patients whose participation in the present study is considered inappropriate by a Principal Investigator or Clinical Investigator.

Related Information

• Primary Sponsor: Dept. of Neurosurgery, Osaka Medical College
• Secondary Sponsor: Translational Research Center
• Source(s) of Monetary Support: Grant from the Ministry of Health and Labor