Multi-institutional Prospective Randomized Comparison of Stereotactic Radiosurgery plus Upfront Whole Brain Radiation Therapy versus Stereotactic Radiosurgery Alone for the treatment of Solitary and Multiple Brain Metastases

Multi-institutional Prospective Randomized Comparison of Stereotactic Radiosurgery plus Upfront Whole Brain Radiation Therapy versus Stereotactic Radiosurgery Alone for the treatment of Solitary and Multiple Brain Metastases - Phase III trial between SRS-alone vs. WBRT+SRS for 1-4 brain mets.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000412

Enrollment

180

Registered

2006-05-01

Start date

1999-10-01

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

1-4 brain metastases, each less than 3cm

Interventions

Stereotactic Radiosurgery (SRS) alone The SRS dose was prescribed to the tumor margin. Metastases with a maximum diameter of up to 2 cm were treated with 22-25 Gy, and those larger than 2 cm were tr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1-4 brain metastases, each with a maximum diameter of no more than 3 cm on contrast-enhanced MRI scans, derived from a histologically confirmed systemic cancer.

Exclusion criteria

Exclusion criteria: Age<18 KPS<70 Pathology: small cell carcinoma, lymphoma, germinoma, and multiple myeloma

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
brain tumor recurrence (BTR), salvage brain treatment, functional preservation, radiation toxicity, and cause of death	—

Countries

Japan

Contacts

Public ContactHidefumi Aoyama

Hokkaido University Radiology

h-aoyama@umin.ac.jp011-706-5977

Outcome results

None listed

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