Status:
COMPLETED
Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer
Lead Sponsor:
Spectrum Pharmaceuticals, Inc
Conditions:
Breast Cancer
Metastases
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
RSR13 (efaproxiral) is a radiation sensitizer that has shown positive results in a Phase 3, randomized clinical trial of patients with brain metastases. Of 111 eligible breast cancer patients with bra...
Detailed Description
The screening process will include documentation of the cancer, which which will require a brain scan and may include a liver scan. Other screening measurements will include a Karnofsky Performance St...
Eligibility Criteria
Inclusion
- Adult women with brain metastases from breast cancer
- Minimum KPS of 70
Exclusion
- Previous treatment for brain metastases, including brain surgery and any form of radiation to the brain
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT00083304
Start Date
February 1 2004
End Date
June 1 2007
Last Update
May 10 2013
Active Locations (94)
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1
Virginia G. Piper Cancer Center, Arizona Oncology Services
Phoenix, Arizona, United States, 85013
2
Arizona Cancer Center, University of Arizona
Tucson, Arizona, United States, 85724-5081
3
The University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
4
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94704