Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075166
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2004-01-02
Brief Title:
Surgery Versus Radiosurgery to Treat Metastatic Brain Tumors
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Prospective Randomized Trial Comparing Surgery Versus Radiosurgery for the Treatment of Metastatic Brain Tumors
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-N-0066 | None | None | None |