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NCT01372774 · ClinicalTrials.gov registry record · Phase 3
Stereotactic Radiosurgery or Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases That Have Been Removed By Surgery
A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 3
- Development phase
- 194
- Enrollment target
NCT01372774: Completed Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT01372774 is a Phase 3 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 194 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01372774, a Phase 3 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 194 participants
- Enrollment target
Study Summary
RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether stereotactic radiosurgery is more effective than whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery. PURPOSE: This randomized phase III trial studies how well stereotactic radiosurgery works compared to whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery.
Primary Outcome
To determine in patients with one to four brain metastases whether there is less nuerocognitive progression post-randomization in patients who receive SRS to the surgical bed compared to patients who receive WBRT. Neurocognitive progression is defined as a drop of at least one stanard deviation from baseline in one of the six neurocognitive tests at post-randomization evaluation.
Interventions
- RADIATION stereotactic radiosurgery
- RADIATION whole-brain radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2011-07 |
| Est. Completion | 2019-12-15 |
| Phase | Phase 3 |
What the finished NCT01372774 record still lists
NCT01372774 is an interventional study that assigns participants to a tested intervention. The registered 194 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 (75% lower).
The record links to 0 conditions, and to 2 interventions - of which stereotactic radiosurgery is the first listed.
NCT01372774 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01372774 about?
NCT01372774 is a clinical study titled "Stereotactic Radiosurgery or Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases That Have Been Removed By Surgery". RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether stereotactic radiosurgery is more effective than whole-brain radiation therapy in t...
What is the current status of trial NCT01372774?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 194 participants. The study started on 2011-07. Estimated completion is 2019-12-15.
What interventions are being tested in trial NCT01372774?
The interventions under investigation include: stereotactic radiosurgery (RADIATION), whole-brain radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT01372774?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01372774's enrollment target sits among peer trials
194 1395th of 2000 higher than 604 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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