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NCT00083304 · ClinicalTrials.gov registry record · Phase 3
Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer
A Phase 3 study, sponsored by Spectrum Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 368
- Enrollment target
NCT00083304: Completed Phase 3 study, sponsored by Spectrum Pharmaceuticals.
NCT00083304 is a Phase 3 study that has completed, run by Spectrum Pharmaceuticals. The registered enrollment target is 368 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00083304, a Phase 3 study, has completed, sponsored by Spectrum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 368 participants
- Enrollment target
Study 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 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.
Interventions
- OTHER Supplemental Oxygen
- RADIATION Whole Brain Radiation Therapy (WBRT)
- DRUG Efaproxiral
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 368 participants |
| Start Date | 2004-02 |
| Est. Completion | 2007-06 |
| Phase | Phase 3 |
What the finished NCT00083304 record still lists
NCT00083304 is an interventional study that assigns participants to a tested intervention. The registered 368 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 3 interventions - of which Supplemental Oxygen is the first listed.
NCT00083304 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00083304 about?
NCT00083304 is a clinical study titled "Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer". 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 ...
What is the current status of trial NCT00083304?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 368 participants. The study started on 2004-02. Estimated completion is 2007-06.
What interventions are being tested in trial NCT00083304?
The interventions under investigation include: Supplemental Oxygen (OTHER), Whole Brain Radiation Therapy (WBRT) (RADIATION), Efaproxiral (DRUG).
Who is sponsoring clinical trial NCT00083304?
This trial is sponsored by Spectrum Pharmaceuticals, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00083304's enrollment target sits among peer trials
368 996th of 2000 higher than 1,003 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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