Combination therapy of boron neutron capture therapy and bevacizumab for recurrent glioma with poor prognosis

JRCT ID: jRCTs051180218

Registered date:27/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: recurrent glioma with poor prognosis
• Date of first enrollment: 02/10/2017
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Protocol treatments consist of BNCT, additional and chemotherapy with bevacizumab. Prescription dose by BNCT is regulated as not to be more than 13 Gy-Eq for normal brain. Additional bevacizumab is given biweekly with 10 mg/kg as long as progressive disease judged by RANO criteria.

Outcome(s)

Primary Outcome

Overall survival OS
It is defined as the period from the treatment start date to the death date due to any cause. In surviving cases, we will terminate halfway with the date of final survival confirmation. In the case of non-follow-up cases, we aborted by the last day that survival was confirmed before becoming impossible to pursue.

Secondary Outcome

PFS by RANO standard
It is defined as the period from the treatment start date to the day when the progression of disease (PD) based on the RANO standard, or until the death date due to any cause. In cases that did not deteriorate, we abort halfway with the final progression-free evacuation date (the date of making a decision other than deterioration). In the case of non-follow-up cases, we abort halfway with the final progression-free confirmation date before becoming impossible to pursue.

Expression of adverse events
Evaluate adverse events and serious adverse events that occurred during treatment or within 30 days after the end of treatment. Observed adverse events are evaluated based on Common Toxicity Criteria for Adverse Events v4.0 (CTCAE v4.0).

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: <= 84age old
• Gender: Both
• Include criteria: See the attached file.
• Exclude criteria: See the attached file.

Related Information

• Primary Sponsor: Miyatake Shin-Ichi
• Secondary ID(s): UMIN000029144