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NCT00582075 · ClinicalTrials.gov registry record · Phase 2

Phase II Study of Gamma Knife Radiosurgery and Temozolomide for Brain Metastases

A Phase 2 study, sponsored by University of Alabama at Birmingham.

Completed
Registry status
Phase 2
Development phase
25
Enrollment target

NCT00582075: Completed Phase 2 study, sponsored by University of Alabama at Birmingham.

NCT00582075 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00582075, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
Phase 2
Development phase
25 participants
Enrollment target

Study Summary

The protocol is designed to determine the efficacy of temozolomide in preventing the development of new brain metastases within the first year in patients undergoing stereotactic radiation for newly diagnosed brain metastases.

Primary Outcome

Patients developing distant brain failure (DBF) at one year. An approximation method was used to arrive at the reported percentage.

Interventions

  • DRUG temozolomide

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2002-07
Est. Completion 2015-06
Phase Phase 2
University of Alabama at Birmingham

1,160 total trials

What the finished NCT00582075 record still lists

NCT00582075 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).

The record links to 0 conditions, and to 1 intervention - of which temozolomide is the first listed.

NCT00582075 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00582075 about?

NCT00582075 is a clinical study titled "Phase II Study of Gamma Knife Radiosurgery and Temozolomide for Brain Metastases". The protocol is designed to determine the efficacy of temozolomide in preventing the development of new brain metastases within the first year in patients undergoing stereotactic radiation for newly diagnosed brain metastases.

What is the current status of trial NCT00582075?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2002-07. Estimated completion is 2015-06.

What interventions are being tested in trial NCT00582075?

The interventions under investigation include: temozolomide (DRUG).

Who is sponsoring clinical trial NCT00582075?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00582075's enrollment target sits among peer trials

25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT00582075, the US trial registry maintained by the National Library of Medicine. NCT00582075 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.