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

This study has been completed.
Sponsor:
Information provided by:
Hokkaido University Hospital
ClinicalTrials.gov Identifier:
NCT00406835
First received: November 30, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  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
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00406835     History of Changes
Other Study ID Numbers: JROSG99-1
Study First Received: November 30, 2006
Last Updated: November 30, 2006
Health Authority: Japan: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 16, 2014