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

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.

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Key information

Conditions

Brain Metastasis Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hokkaido University School of Medicine

Sapporo, Hokkaido, 060-8638, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whole-Brain Radiation Therapy, Stereotactic Radiosurgery

Procedure

Sponsors and collaborators

Lead sponsor

Hokkaido University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 1999
Study completion: 2005
First posted: Dec 4, 2006
Registry last updated: Dec 4, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed