TTF therapy for pediatric glioblastoma

JRCT ID: jRCTs032200423

Registered date:01/04/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Glioblastoma
• Date of first enrollment: 25/11/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Tumor treating field therapy using NovoTTF-100A for 28 days as a course, repeating up to 26 courses.

Outcome(s)

• Primary Outcome: rate of adverse events with causality

Secondary Outcome

1. Response rate
2. Clinical benefit rate
3. Event-free survival rate (6 months and 1 year)
4. Overall survival rate (1 and 2 years)
5. Event-free survival
6. Overall survival
7. QOL (PedsQL Core scale & Brain tumor module)
8. rate of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 5age old
• Age maximum: < 18age old
• Gender: Both

Include criteria

1. Histopathological diagnosis with glioblastoma
2. Main disease located in the supratentorial region
3. Aged between 5 and 17
4. Newly diagnosed or first recurrence
5. After completion of clinically indicated surgical resection of the tumor
6. After completion of clinically indicated radiation therapy, or due of the completion is within 14 days
7. Karnofsky/Lansky performance status (PS) equals to or more than 70
8. Written informed consent from the patient and/or the guardian

Exclude criteria

1. Life expectancy less than 3 months due to disease progression
2. Uncontrollable infection or organ damage
3. More than 100 days after diagnosis (or diagnosis of the recurrence in a recurrent case)
4. Treated with implantable medical devices
5. Other experimental treatment for glioblastoma
6. Pregnancy or possibility of pregnancy
7. Other reasons with which the responsible doctor judge that registration to the trial is inappropriate

Related Information

• Primary Sponsor: Yuza Yuki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development
• Secondary ID(s): Nil known