Brain NeoplasmsPhase 4NCT00075166
Surgery Versus Radiosurgery to Treat Metastatic Brain Tumors
A Phase 4 study testing Stereotactic surgery (SRS) and Craniotomy in people with Brain Neoplasms and Neoplasm Metastasis, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Neoplasms, Neoplasm Metastasis
- What is being tested?
- Stereotactic surgery (SRS) and Craniotomy
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Nov 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must:
- be 21 years of age or older.
- have a histologically confirmed primary malignancy.
- be able to undergo an MRI scan of the brain.
- have one to three intraparenchymal brain metastases as identified on a brain MRI scan with intravenous contrast.
- have contrast enhancing tumor(s) that are well circumscribed and less than or equal to 4.0 cm in any dimension.
- be appropriate for either procedure as determined by both a neurosurgeon and a radiation oncologist.
Who cannot join
- Patients must not:
- have tumor(s) in the midbrain, pons, or medulla - patients undergoing surgical resections in these areas are highly likely to develop significant neurological deficits or death.
- have tumors within 10 millimeters of the optic apparatus (nerves and chiasm) or the area postrema - patients undergoing SRS to these areas are at significant risk of developing permanent blindness or intractable nausea.
- be poor operative candidates from an anesthetic point of view secondary to other major medical illnesses - the risk of undergoing general anesthesia outweighs the potential benefit of undergoing surgical resection of a brain metastasis.
- have a coagulopathy demonstrated by an abnormal prothrombin time, activated partial thromboplastin time, or thrombocytopenia (platelet count less that 150,000 platelets/mm3) - the risk of developing uncontrollable intra-operatively bleeding outweighs the potential benefit of undergoing surgical resection of a brain metastasis.
- have radiographic or cerebrospinal fluid specimen evidence of widespread leptomeningeal metastasis - neither surgery nor SRS is a useful treatment modality for this condition.
Show all 13Show fewer
- significant psychiatric impairments which, in the opinion of the investigators, will interfere with the proper administration or completion of the protocol - self explanatory.
- acute or untreated infections (viral, bacterial or fungal) - patients with active infections are highly likely to have spread of their infections to the brain as a result of a craniotomy.
- be pregnant at the time of the randomized treatment - general anesthesia and surgery may subject the fetus to unacceptable risks. Also, the NIH does not offer full obstetrical services in the event that medical care to the mother and/or fetus is required. Pregnant women presenting with brain metastases will be referred to facilities offering OB/GYN services.
- be prisoners or other institutionalized individuals - these individuals are at risk of being susceptible to undue influences to participate in a research protocol against their free will.
- have a diagnosis of germ cell tumor, lymphoma or small cell lung cancer - these tumors are highly radiosensitive and should therefore be treated with radiation.
- have any of the following: aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or auto defibrillator, cochlear implant, ocular foreign body or implant [e.g. metal shavings, retinal clips], or insulin pump as these items would be contra-indications to undergoing an MRI scan.
- have an allergy to iodine or shellfish or have previously had an allergic reaction to iodinated-contrast agents as this is a contra-indication to undergoing a contrast enhanced CT of the brain - a contrast enhanced CT of the brain is required for the planning of SRS.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Brain Neoplasms, Neoplasm Metastasis
- Being tested
- Stereotactic surgery (SRS), Craniotomy
- Keywords
- Stereotactic, Carcinoma, Melanoma, Surgical Resection, Metastases, Metastatic Brain Tumor, Surgery, Radiosurgery, Treatment
- Medical subject headings
- Brain Neoplasms, Neoplasm Metastasis, Carcinoma, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic surgery (SRS)Procedure or surgery
CraniotomyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2004 (estimated)
- Study startDec 2003
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Enrolment
- 130 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00075166
- Sponsor's protocol ID
- 040066
- Other IDs
- 04-N-0066
- Status last verified
- Nov 2005
- First submitted
- 2 Jan 2004
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Wen PY, Loeffler JS. Brain metastases. Curr Treat Options Oncol. 2000 Dec;1(5):447-58. doi: 10.1007/s11864-000-0072-3.
PubMed 12057152Johnson JD, Young B. Demographics of brain metastasis. Neurosurg Clin N Am. 1996 Jul;7(3):337-44.
PubMed 8823767Posner JB. Management of brain metastases. Rev Neurol (Paris). 1992;148(6-7):477-87.
PubMed 1448668
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial Comparing Surgery Versus Radiosurgery for the Treatment of Metastatic Brain Tumors
- ClinicalTrials.gov ID
- NCT00075166
- Acronym / sponsor ID
- 040066
- Conditions
- Brain Neoplasms, Neoplasm Metastasis
- Keywords
- Stereotactic, Carcinoma, Melanoma, Surgical Resection, Metastases, Metastatic Brain Tumor, Surgery, Radiosurgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Dec 2003
- Study completion
- Nov 2005
- First posted
- 5 Jan 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- be 21 years of age or older.
- have a histologically confirmed primary malignancy.
- be able to undergo an MRI scan of the brain.
- have one to three intraparenchymal brain metastases as identified on a brain MRI scan with intravenous contrast.
- have contrast enhancing tumor(s) that are well circumscribed and less than or equal to 4.0 cm in any dimension.
Key exclusion criteria (13 listed)
- have tumor(s) in the midbrain, pons, or medulla - patients undergoing surgical resections in these areas are highly likely to develop significant neurological deficits or death.
- have tumors within 10 millimeters of the optic apparatus (nerves and chiasm) or the area postrema - patients undergoing SRS to these areas are at significant risk of developing permanent blindness or intractable nausea.
- be poor operative candidates from an anesthetic point of view secondary to other major medical illnesses - the risk of undergoing general anesthesia outweighs the potential benefit of undergoing surgical resection of a brain metastasis.
- have a coagulopathy demonstrated by an abnormal prothrombin time, activated partial thromboplastin time, or thrombocytopenia (platelet count less that 150,000 platelets/mm3) - the risk of developing uncontrollable intra-operatively bleeding outweighs the potential benefit of undergoing surgical resection of a brain metastasis.
- have radiographic or cerebrospinal fluid specimen evidence of widespread leptomeningeal metastasis - neither surgery nor SRS is a useful treatment modality for this condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic surgery (SRS) | Procedure or surgery | – |
| Craniotomy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 12057152Wen PY, Loeffler JS. Brain metastases. Curr Treat Options Oncol. 2000 Dec;1(5):447-58. doi: 10.1007/s11864-000-0072-3.
- Background: PubMed 8823767Johnson JD, Young B. Demographics of brain metastasis. Neurosurg Clin N Am. 1996 Jul;7(3):337-44.
- Background: PubMed 1448668Posner JB. Management of brain metastases. Rev Neurol (Paris). 1992;148(6-7):477-87.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stereotactic surgery (SRS) and Craniotomy in people with Brain Neoplasms and Neoplasm Metastasis, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00075166, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.