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

November 30, 2006 updated by: Hokkaido University Hospital

Phase 3 Study of Whole Brain Radiation Therapy Plus Stereotactic Radiosurgery Versus Stereotactic Radiosurgery 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8638
        • Hokkaido University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hokkaido University Hospital

Investigators

  • Principal Investigator: Hidefumi Aoyama, MD, PhD, Hokkaido University School of Medicine
  • Study Chair: Hiroki Shirato, MD, PhD, Hokkaido University School of Medicine
  • Study Director: Keiichi Nakagawa, MD, PhD, Tokyo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1999

Study Completion

April 1, 2005

Study Registration Dates

First Submitted

November 30, 2006

First Submitted That Met QC Criteria

November 30, 2006

First Posted (Estimate)

December 4, 2006

Study Record Updates

Last Update Posted (Estimate)

December 4, 2006

Last Update Submitted That Met QC Criteria

November 30, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JROSG99-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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