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NCT00587964 · ClinicalTrials.gov registry record · Phase 2

Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases

A Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.

Completed
Registry status
Phase 2
Development phase
51
Enrollment target

NCT00587964: Completed Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.

NCT00587964 is a Phase 2 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 51 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00587964, a Phase 2 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
51 participants
Enrollment target

Study Summary

For patients who have one or two metastases in the brain, the tumor(s) can often be removed with surgery to relieve symptoms from the tumor(s) and to improve survival. However, about half of all patients who have the tumor(s) removed with surgery will develop regrowth (recurrence) of the tumor. To prevent this regrowth of tumor, some patients receive radiation to the entire brain (whole brain radiation) after surgery. This involves daily treatment for about two to three weeks, and may cause long-term neurological problems, such as memory loss. Stereotactic radiosurgery (SRS) is sometimes used instead of surgery to treat brain metastasis. This involves the use of a special head frame and sophisticated computer programs that enable us to deliver a high dose of radiation to a small focused area of the brain in only one treatment. Research has shown that the results of treatment with SRS are as good as surgical removal of the tumor. SRS and surgical resection are considered the standard options for the treatment of brain metastases. This Phase II clinical trial is studying the combination of these two techniques. The purpose of this study is to evaluate the use of SRS following surgical removal of brain metastases. The outcomes we will be looking at are tumor regrowth after treatment and side effects of treatment.

Primary Outcome

following a combination of stereotactic radiosurgery and surgical resection for brain metastases; to determine the incidence of the brain injury following the combination therapy. Local control: Absence of radiographic evidence of tumor at the site of therapy constitutes local control of the treated disease.Recurrence in the treated region: The reappearance of tumor on any MRI or CT scan at the site of treatment constitutes recurrent disease at the treated region. Recurrence outside the treated

Interventions

  • RADIATION Stereotactic Radiosurgery

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2004-06
Est. Completion 2009-01
Phase Phase 2
Memorial Sloan Kettering Cancer Center

1,884 total trials

What the finished NCT00587964 record still lists

NCT00587964 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).

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

NCT00587964 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00587964 about?

NCT00587964 is a clinical study titled "Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases". For patients who have one or two metastases in the brain, the tumor(s) can often be removed with surgery to relieve symptoms from the tumor(s) and to improve survival. However, about half of all patients who have the tumor(s) removed with surgery will develop regrowth (recurrence) of the tumor. To p...

What is the current status of trial NCT00587964?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2004-06. Estimated completion is 2009-01.

What interventions are being tested in trial NCT00587964?

The interventions under investigation include: Stereotactic Radiosurgery (RADIATION).

Who is sponsoring clinical trial NCT00587964?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00587964's enrollment target sits among peer trials

51 1190th of 2000 higher than 806 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 NCT00587964, the US trial registry maintained by the National Library of Medicine. NCT00587964 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.