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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00406835
First Posted: December 4, 2006
Last Update Posted: December 4, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hokkaido University Hospital
  Purpose
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.

Condition Intervention Phase
Brain Metastasis Procedure: Whole-Brain Radiation Therapy, Stereotactic Radiosurgery Phase 3

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Phase 3 Study of Whole Brain Radiation Therapy Plus Stereotactic Radiosurgery Versus Stereotactic Radiosurgery Alone for 1-4 Brain Metastases

Further study details as provided by Hokkaido University Hospital:

Estimated Enrollment: 180
Study Start Date: October 1999
Estimated Study Completion Date: April 2005
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00406835


Locations
Japan
Hokkaido University School of Medicine
Sapporo, Hokkaido, Japan, 060-8638
Sponsors and Collaborators
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
  More Information

ClinicalTrials.gov Identifier: NCT00406835     History of Changes
Other Study ID Numbers: JROSG99-1
First Submitted: November 30, 2006
First Posted: December 4, 2006
Last Update Posted: December 4, 2006
Last Verified: November 2006

Keywords provided by Hokkaido University Hospital:
Whole Brain Radiation Therapy
Stereotactic Radiosurgery
Brain metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases