Phase 3 Study of Whole Brain Radiation Therapy Plus Stereotactic Radiosurgery Versus Stereotactic Radiosurgery Alone for 1-4 Brain Metastases
18 Years
N/A
Both
Brain Metastasis
Trial Information
Phase 3 Study of Whole Brain Radiation Therapy Plus Stereotactic Radiosurgery Versus Stereotactic Radiosurgery Alone for 1-4 Brain Metastases
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.
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.
Type of Study:
Observational
Study Design:
Observational Model: Defined Population, Time Perspective: Longitudinal, Time Perspective: Prospective
Principal Investigator
Hidefumi Aoyama, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hokkaido University School of Medicine
Authority:
Japan: Institutional Review Board
Study ID:
JROSG99-1
NCT ID:
NCT00406835
Start Date:
October 1999
Completion Date:
April 2005
Related Keywords:
- Brain Metastasis
- Whole Brain Radiation Therapy
- Stereotactic Radiosurgery
- Brain metastases
- Neoplasm Metastasis
- Neoplasms, Second Primary
- Brain Neoplasms
Name | Location |
|---|
