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NCT00406835 Clinical Trial

Prospective Randomized Trial Between WBRT Plus SRS Versus SRS Alone for 1-4 Brain Metastases

Brain Metastasis Clinical Trial

Official title:
Phase 3 Study of Whole Brain Radiation Therapy Plus Stereotactic Radiosurgery Versus Stereotactic Radiosurgery Alone for 1-4 Brain Metastases

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00406835
Other study ID # JROSG99-1
Secondary ID
Status Completed
Phase Phase 3
First received November 30, 2006
Last updated November 30, 2006
Start date October 1999
Est. completion date April 2005

Study information
Verified date November 2006
Source Hokkaido University Hospital
Contact n/a
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine if WBRT combined with SRS resulted in improvements in survival, brain tumor control, functional preservation rate, and frequency of neurologic death.

Description:

Whole-Brain Radiation Therapy (WBRT) had been a mainstay in the treatment of brain metastases. However, treatment strategy which rely on Stereotactic Radiosurgery (SRS) has becoming popular in Japan. It is not well understood if the Whole-Brain Radiation Therapy (WBRT) combined with Stereotactic Radiosurgery (SRS) resulted in improvements in survival, brain tumor control, functional preservation rate, and frequency of neurologic death. In orer to determine the role of WBRT, we conducted prospective randomized trial between WBRT+SRS and SRS-alone for 1-4 brain metastatic patients.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date April 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years of age or older with 1-4 brain metastases, each with a maximum diameter of no more than 3 cm on contrast-enhanced MRI scans, and were derived from a histologically confirmed systemic cancer, Karnofsky Performance Status (KPS) score of 70 or more

Exclusion Criteria:

- Patients with metastases from small cell carcinoma, lymphoma, germinoma, and multiple myeloma were excluded.

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Intervention

Procedure:
• Whole-Brain Radiation Therapy, Stereotactic Radiosurgery

Locations
Country Name City State
Japan Hokkaido University School of Medicine Sapporo Hokkaido

Sponsors (1)
Lead Sponsor Collaborator
Hokkaido University Hospital

Country where clinical trial is conducted

Japan, 

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