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Low-dose Whole Brain Radiation Therapy combined with Stereotactic Radiosurgery for Brain Metastases: Multi-institutional Phase II study (JROSG13-1)

Low-dose Whole Brain Radiation Therapy combined with Stereotactic Radiosurgery for Brain Metastases: Multi-institutional Phase II study (JROSG13-1) - Low-dose Whole Brain Radiation Therapy combined with Stereotactic Radiosurgery for Brain Metastases: Multi-institutional Phase II study (JROSG13-1)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009055
Enrollment
70
Registered
2012-10-09
Start date
2012-05-01
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

Brain metastases

Interventions

Low-dose whole brain radiotherapy (25 Gy in 10 fractions)

Sponsors

Niigata University, Dept of Radiology, Japanese Radiation Oncology Study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Age: 20-80 years old 2) Systemic status: KPS >= 70 3) Histopathologically confirmed 3) Indication for stereotactic irradiation (number of brain metastases, 4 or less, maximum tumor diameter, 3 cm of less) 5) Consent to neurocognitive fuctional tests and QOL questionnaire 6) Consent to this study

Exclusion criteria

Exclusion criteria: 1) severe decline in neurocognitive function or language ability at baseline 2) history of brain radiation therapy 3) history of brain surgery of brain metastases 4) small cell carcinoma, germinoma, lymphoma 5) any other reasons not to fit to this study

Design outcomes

Primary

MeasureTime frame
Development rate of distant brain metastases at 6-month after treatment

Secondary

MeasureTime frame
1) Neurocognitive function at 4-month 2) Neurocognitive function at 12-month 3) Local tumor control of brain metastases 4) Overall survival 5) Cause of death

Countries

Japan

Contacts

Public ContactHidefumi Aoyama

Niigata Univerisity Graduate School of Medical and Dental Sciences Radiology

jrosg13-1@med.niigata-u.ac.jp025-227-2315

Outcome results

None listed

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