Surgery Versus Radiosurgery to Treat Metastatic Brain Tumors

NCT00075166 | Completed Phase 4

• 2 other identifiers: 04006604-N-0066
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Neoplasms; Neoplasm Metastasis

Keywords

Stereotactic; Carcinoma; Melanoma; Surgical Resection; Metastases; Metastatic Brain Tumor; Surgery; Radiosurgery; Treatment

Interventions

Stereotactic surgery (SRS) PROCEDURE

Craniotomy PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Wen PY, Loeffler JS. Brain metastases. Curr Treat Options Oncol. 2000 Dec;1(5):447-58. doi: 10.1007/s11864-000-0072-3.

  PMID: 12057152 BACKGROUND

• Johnson JD, Young B. Demographics of brain metastasis. Neurosurg Clin N Am. 1996 Jul;7(3):337-44.

  PMID: 8823767 BACKGROUND

• Posner JB. Management of brain metastases. Rev Neurol (Paris). 1992;148(6-7):477-87.

  PMID: 1448668 BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms; Neoplasm Metastasis; Carcinoma; Melanoma

Interventions

Craniotomy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 2, 2004
• First Posted: January 5, 2004
• Study Start: December 1, 2003
• Study Completion: November 1, 2005
• Last Updated: March 4, 2008

Record last verified: 2005-11

Locations

US (1)