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NCT00460395 · ClinicalTrials.gov registry record · Phase 3
Surgery Versus Stereotactic Radiosurgery in the Treatment of Single Brain Metastasis: A Randomized Trial
A Phase 3 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 64
- Enrollment target
NCT00460395: Completed Phase 3 study, sponsored by M.D. Anderson Cancer Center.
NCT00460395 is a Phase 3 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 64 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00460395, a Phase 3 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 64 participants
- Enrollment target
Study Summary
Study Objectives: * To compare the survival (overall, systemic, and neurological) of patients with single cerebral metastases treated with either conventional surgical resection or stereotactic radiosurgery. * To compare their rates of recurrence, complications, and their cognitive ability, functional status, and quality of life. Although surgical resection is a proven and effective treatment for brain metastases in patients with systemic cancer, stereotactic radiosurgery has been suggested to be equally effective and less morbid. Nonrandomized retrospective comparisons have been unable to resolve whether stereotactic radiosurgery is as effective as conventional surgery because of the complexity and variability of the population of patients with cancer and brain metastases. This controversy can only be resolved by a prospective randomized trial comparing these treatment modalities. Patients not randomized will be analyzed as a separate group.
Interventions
- PROCEDURE Surgery
- PROCEDURE Stereotactic radiosurgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 1998-01 |
| Est. Completion | 2005-12 |
| Phase | Phase 3 |
What the finished NCT00460395 record still lists
NCT00460395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Surgery is the first listed.
NCT00460395 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00460395 about?
NCT00460395 is a clinical study titled "Surgery Versus Stereotactic Radiosurgery in the Treatment of Single Brain Metastasis: A Randomized Trial". Study Objectives: * To compare the survival (overall, systemic, and neurological) of patients with single cerebral metastases treated with either conventional surgical resection or stereotactic radiosurgery. * To compare their rates of recurrence, complications, and their cognitive ability, functio...
What is the current status of trial NCT00460395?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 64 participants. The study started on 1998-01. Estimated completion is 2005-12.
What interventions are being tested in trial NCT00460395?
The interventions under investigation include: Surgery (PROCEDURE), Stereotactic radiosurgery (PROCEDURE).
Who is sponsoring clinical trial NCT00460395?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00460395's enrollment target sits among peer trials
64 1799th of 2000 higher than 201 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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