Phase 2 study of whole brain radiotherapy with hippocampal-avoidance and simultaneous integrated boost to brain metastases using intensity modulated radiotherapy

Phase 2 study of whole brain radiotherapy with hippocampal-avoidance and simultaneous integrated boost to brain metastases using intensity modulated radiotherapy - BM HA-SIB-IMRT P2

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010226

Enrollment

Registered

2013-03-12

Start date

2013-03-12

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 metastasis

Interventions

A total dose of 30Gy is delivered in 15 fractions to whole brain, whereas 63Gy is delivered simultaneously to brain metastases. The maximum dose to bilateral hippocampus should be limited to &lt

15Gy.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Pathologically or clinically diagnosed primary malignant solid tumor 2) No history of radiotherapy for brain metastasis 3) No indication for surgical resection for brain metastasis 4) 1 to 10 brain metastases diagnosed by Gd-enhanced MRI 5) Maximum tumor diameter <3.5cm & the next largest tumor <3cm & other tumor diameters <1cm 6) KPS (karmofsky Performance Status) = or <70 7) Written informed consent

Exclusion criteria

Exclusion criteria: 1) The distance of hippocampus to metastatic brain tumor < 1.5cm 2) Unknown primary site 3) Primary tumor histology of small cell lung cancer, lymphoma or other blood tumor 4) Radiologically or clinically suspected carcinomatous meningitis 5) With critical comorbidity 6) Allergy to Gd contrast medium 7) In pregnancy or with expectation of pregnancy

Design outcomes

Primary

Measure	Time frame
Intracranial progression-free survival	—

Secondary

Measure	Time frame
Tumor response, Local progression-free survival, Intracranial new lesion-free survival, Morbidity, Time to deterioration of neurocognitive function, Overall survival	—

Countries

Japan

Contacts

Public ContactKoji Inaba

National Cancer Center Hospital, Tokyo, Japan Division of Radiation Oncology

koji_i_14@yahoo.co.jp03-3542-2511

Outcome results

None listed

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