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NCT00075166 · ClinicalTrials.gov registry record · Phase 4
Surgery Versus Radiosurgery to Treat Metastatic Brain Tumors
A Phase 4 study of Neoplasm Metastasis and Brain Neoplasms, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 4
- Development phase
- 130
- Enrollment target
- 1
- Study location
NCT00075166 is a Phase 4 study of Neoplasm Metastasis and Brain Neoplasms that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 130 participants, below the 413-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00075166, a Phase 4 study of Neoplasm Metastasis and Brain Neoplasms, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 130 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will compare the effectiveness of craniotomy to that of stereotactic surgery (SRS) for the treatment of metastatic brain tumors - tumors that first develop elsewhere in the body and then travel to the brain. Craniotomy is surgical removal of the tumors through an operation. SRS consists of highly focused radiation doses to the tumors. Neither treatment is experimental and both have shown benefits to patients with metastatic brain tumors. This study will determine whether one treatment is superior to the other in prolonging patient survival. Patients 21 years of age and older with one to three metastatic brain tumors may be eligible for this study. Participants will have a medical history and physical examination, blood and urine tests, an electrocardiogram, and chest x-ray. They will then be randomly assigned to undergo either surgery or SRS. Before either procedure, patients will have a magnetic resonance imaging (MRI) scan. MRI uses a strong magnetic field and radio waves to obtain images of the brain. Patients scheduled for SRS will have a computed tomography (CT) scan in addition to the MRI. CT uses X-rays to obtain images of the brain. During the CT, a contrast agent is injected through an IV tube placed in a vein to enhance the CT images. For both the MRI and CT tests, the patient lies on a table that slides into a cylindrical scanner. The MRI usually lasts between 45 and 90 minutes, while the CT scan lasts for about 30 to 60 minutes. Patients scheduled for surgery will have general anesthesia or local anesthesia with sedation. They will be in intensive care after the surgery until their condition is stable. Before being discharged home, they will have another MRI scan. The surgical sutures or staples will be removed 7 to 10 days after surgery. Patients scheduled for SRS will have their scalp numbed with medicine and their head will be placed in a head frame. A CT scan will be done on the morning of the procedure to plan the treatment. Around noo
Conditions Studied
Interventions
- PROCEDURE Craniotomy
- PROCEDURE Stereotactic surgery (SRS)
Study Locations (1)
Maryland
- National Institute of Neurological Disorders and Stroke (NINDS) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2003-12 |
| Est. Completion | 2005-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00075166
The ClinicalTrials.gov registry entry for NCT00075166 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 413-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (69% lower). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Neoplasm Metastasis appearing as the primary indexed condition, and to 2 interventions - of which Craniotomy is the first listed.
NCT00075166 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00075166 about?
NCT00075166 is a clinical study titled "Surgery Versus Radiosurgery to Treat Metastatic Brain Tumors". This study will compare the effectiveness of craniotomy to that of stereotactic surgery (SRS) for the treatment of metastatic brain tumors - tumors that first develop elsewhere in the body and then travel to the brain. Craniotomy is surgical removal of the tumors through an operation. SRS consists o...
What is the current status of trial NCT00075166?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 130 participants. The study started on 2003-12. Estimated completion is 2005-11.
What conditions does trial NCT00075166 study?
This clinical trial studies the following conditions: Neoplasm Metastasis, Brain Neoplasms.
What interventions are being tested in trial NCT00075166?
The interventions under investigation include: Craniotomy (PROCEDURE), Stereotactic surgery (SRS) (PROCEDURE).
Who is sponsoring clinical trial NCT00075166?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00075166 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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