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

UMIN ID: C000000412

Registered date:01/05/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: 1-4 brain metastases, each less than 3cm
• Date of first enrollment: 1999/10/01
• Target sample size: 180
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 treated with 18-20 Gy.
Whole Brain Radiotherapy plus SRS. The WBRT schedule was 30 Gy in 10 fractions over 2 to 2.5 weeks. SRS dose was 30% reduced from SRS-alone arm.

Outcome(s)

• Primary Outcome: overall survival
• Secondary Outcome: brain tumor recurrence (BTR), salvage brain treatment, functional preservation, radiation toxicity, and cause of death

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Age<18 KPS<70 Pathology: small cell carcinoma, lymphoma, germinoma, and multiple myeloma

Related Information

• Primary Sponsor: Japanese Radiation Oncology Study Group
• Source(s) of Monetary Support: Japanese Radiation Oncology Study Group
• Secondary ID(s): JROSG99-1