Surgery Versus Radiosurgery to Treat Metastatic Brain Tumors
|ClinicalTrials.gov Identifier: NCT00075166|
Recruitment Status : Completed
First Posted : January 5, 2004
Last Update Posted : March 4, 2008
|First Submitted Date ICMJE||January 2, 2004|
|First Posted Date ICMJE||January 5, 2004|
|Last Update Posted Date||March 4, 2008|
|Study Start Date ICMJE||December 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00075166 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Surgery Versus Radiosurgery to Treat Metastatic Brain Tumors|
|Official Title ICMJE||A Prospective, Randomized Trial Comparing Surgery Versus Radiosurgery for the Treatment of 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 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 noon, the treatment, which consists of brief exposures to radiation, will be administered with the patient positioned comfortably on a treatment couch. The treatment will be completed in 1 to 2 hours, after which the head frame will be removed. After a brief period of observation, the patient will be discharged home.
Patients will return to NIH for follow-up visits within 4 weeks after surgery or SRS and then every 3 months after that for a medical history, physical examination, and MRI scan, and to complete a quality of life questionnaire.
Introduction: Metastatic brain tumors occur more frequently than primary brain tumors and occur in approximately 25% of patients who die of cancer each year. The main treatment goals for patients with brain metastases are the relief of neurological symptoms and long-term control of the tumors. Glucocorticoids and external beam whole brain radiation therapy (WBRT) comprise the current standard of care and increase median survival from one month to three to six months. Patients with three or less tumors (greater than 70% of patients) also commonly undergo surgery or stereotactic radiosurgery (SRS) with the goal of lengthening survival. Two prospective randomized trials have shown a significant survival benefit for patients undergoing surgical resection of single tumors in combination with WBRT compared to patients receiving WBRT alone. Although there have been no prospective randomized studies comparing SRS and WBRT to WBRT alone, there have been numerous large retrospective series reporting a significant survival benefit from SRS. To date, a prospective randomized trial comparing surgery to SRS has not been reported. Despite the lack of rigorous data, there are proponents for each of these treatment modalities. Those in favor of surgery cite the ability to achieve a complete resection in most cases, the almost immediate relief of symptoms, and the low rate of local recurrence. Those in favor of SRS cite an equivalent degree of local tumor control compared to surgery, the relative ease of the one day outpatient procedure, and the ability to treat lesions in deeper brain structures.
Objectives: We plan to determine in a prospective randomized manner if surgery is superior to SRS for prolonging survival in patients with one to three surgically accessible brain tumors.
Study Population: Patients aged twenty one years and older with one to three brain metastases will be assessed for enrollment in this study.
Design: Patients who meet eligibility criteria will be randomly assigned to undergo either surgery or SRS for their tumors. Patients will then be followed at regularly scheduled intervals for the duration of their disease.
Outcome measures: The primary outcome measure will be time of survival following treatment. Among the secondary outcomes that will be measured over time are tumor recurrence or progression, neurologic sign or symptom development, functional independence, steroid and anticonvulsant use, and overall quality of life.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Primary Purpose: Treatment|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||November 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Patients must not:
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00075166|
|Other Study ID Numbers ICMJE||040066
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||November 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP