Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer
Public ClinicalTrials.gov record NCT00083304. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Randomized, Open-label Comparative Study of Standard Whole Brain Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Women With Brain Metastases From Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 brain metastases in that trial, 59 patients who received RSR13 prior to radiation therapy had a median survival time that was twice as long as the 52 patients who did not receive RSR13 prior to radiation therapy. RSR13 (efaproxiral) is an experimental drug that increases the amount of oxygen released from blood into the tissues. It is well known that certain types of cancer tumors, including those in brain metastases, lack oxygen. Lack of oxygen in a tumor can reduce the effect of radiation therapy (RT). RSR13 may increase the oxygen level in brain tumors so that radiation therapy works better. This study will enroll up to 360 women with brain metastases from breast cancer, and will evaluate if whole brain radiation therapy given with RSR13 will have a better treatment effect than whole brain radiation therapy alone. RSR13 will be infused intravenously (IV) through a central catheter placed in a central vein. Women randomized (assigned) to receive RSR13, therefore, will need to have a central catheter placed for treatment unless one is already in place.
Study identification
- NCT ID
- NCT00083304
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 368 participants
Conditions and interventions
Conditions
Interventions
- Efaproxiral Drug
- Whole Brain Radiation Therapy (WBRT) Radiation
- Supplemental Oxygen Other
Drug · Radiation · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2004
- Primary completion
- May 31, 2007
- Completion
- May 31, 2007
- Last update posted
- May 9, 2013
2004 – 2007
United States locations
- U.S. sites
- 39
- U.S. states
- 21
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Virginia G. Piper Cancer Center, Arizona Oncology Services | Phoenix | Arizona | 85013 | — |
| Arizona Cancer Center, University of Arizona | Tucson | Arizona | 85724-5081 | — |
| The University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| Alta Bates Comprehensive Cancer Center | Berkeley | California | 94704 | — |
| University of California at Los Angeles | Los Angeles | California | 90095 | — |
| Radiological Associates of Sacramento | Sacramento | California | 95816 | — |
| UCSF - Comprehensive Cancer Center | San Francisco | California | 94115 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | — |
| Boca Raton Community Hospital | Boca Raton | Florida | 33486 | — |
| University of Miami Medical | Miami | Florida | 33136 | — |
| University of South Florida - H. Lee Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Emory University Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Parkview Research Center | Fort Wayne | Indiana | 46805 | — |
| Indiana University School of Medicine | Indianapolis | Indiana | 46204 | — |
| Siouxland Regional Cancer Center | Sioux City | Iowa | 51101 | — |
| Johns Hopkins Oncology Center | Baltimore | Maryland | 21231 | — |
| Maryland Hematology Oncology | Baltimore | Maryland | 21236 | — |
| Franklin Square Hospital Center | Baltimore | Maryland | 21237 | — |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| University of Minnesota Cancer Center | Minneapolis | Minnesota | 55455 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Dent Neurologic Institute | Amherst | New York | 14226 | — |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | — |
| Eastchester Center for Cancer Care | The Bronx | New York | 10469 | — |
| University of North Carolina Breast Center | Chapel Hill | North Carolina | 27599 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| University of Cincinnati Division of Hematology-Oncology | Cincinnati | Ohio | 45267 | — |
| Cleveland Clinic Hospital | Cleveland | Ohio | 44195 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Texas Oncology | Dallas | Texas | 75230 | — |
| Texas Oncology | Fort Worth | Texas | 76104 | — |
| Virginia Mason Cancer Center | Seattle | Washington | 98101 | — |
| Wenatchee Valley Clinic | Wenatchee | Washington | 98801 | — |
| University of Wisconsin | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 55 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00083304, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 9, 2013 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00083304 live on ClinicalTrials.gov.