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

NCT ID: NCT00406835

Last Updated: 2006-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-10-31

Study Completion Date

2005-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Brain Metastasis

Keywords

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Whole Brain Radiation Therapy Stereotactic Radiosurgery Brain metastases

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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Whole-Brain Radiation Therapy, Stereotactic Radiosurgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hokkaido University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Hidefumi Aoyama, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hokkaido University School of Medicine

Hiroki Shirato, MD, PhD

Role: STUDY_CHAIR

Hokkaido University School of Medicine

Keiichi Nakagawa, MD, PhD

Role: STUDY_DIRECTOR

Tokyo University

Locations

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Hokkaido University School of Medicine

Sapporo, Hokkaido, Japan

Site Status

Countries

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Japan

Other Identifiers

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JROSG99-1

Identifier Type: -

Identifier Source: org_study_id