Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by Spectrum Pharmaceuticals. The registered enrollment target is 368 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00083304
The ClinicalTrials.gov registry entry for NCT00083304 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 368 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spectrum Pharmaceuticals, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Supplemental Oxygen is the first listed.
NCT00083304 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.