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Trial Title:
Stereotactic Radiosurgery Compared to Observation in Treating Patients With Brain Metastases
NCT ID:
NCT00950001
Condition:
Metastatic Malignant Neoplasm in the Brain
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Stereotactic Radiosurgery
Description:
Undergo SRS
Arm group label:
Arm I (SRS)
Other name:
Stereotactic External Beam Irradiation
Other name:
stereotactic external-beam radiation therapy
Other name:
stereotactic radiation therapy
Other name:
Stereotactic Radiotherapy
Other name:
stereotaxic radiation therapy
Other name:
stereotaxic radiosurgery
Summary:
This randomized phase III trial studies stereotactic radiosurgery to see how well it
works compared to clinical observation after surgery in treating patients with brain
metastases. Stereotactic radiosurgery, a type of radiation therapy, may be able to send
x-rays directly to the tumor and cause less damage to normal tissue.
Detailed description:
PRIMARY OBJECTIVES:
I. To evaluate benefit of post-surgical stereotactic radiosurgery (SRS) on the resection
bed in providing 6 month local control (decreasing the risk of local tumor recurrence)
when compared to surgical resection alone.
SECONDARY OBJECTIVES:
I. Overall survival, development of distant brain metastases and complications related to
treatment.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo stereotactic radiosurgery to the surgical cavity within 30 days
of the craniotomy.
ARM II: Patients undergo clinical observation after craniotomy.
After completion of study treatment, patients are followed up at 5-8 weeks, every 6-9
weeks for 1 year, every 3-4 months for 1 year, and then every 6 months thereafter.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients must be older than 3 years of age (radiosurgical frames cannot be placed on
children younger than age 3).
2. Patients must have 3 or fewer newly diagnosed metastatic lesions in the brain with a
complete resection of at least one lesion as determined the study neuroradiologist.
3. The resection cavity must have a maximum diameter of less than or equal to 4cm. This
criteria will be determined by the study radiologist.
4. Additional unresected brain metastases (up to 2) must have a maximum diameter of
less than or equal to 3 cm.
5. Patients must be considered candidates for SRS within 30 days of surgical resection.
6. Patients must have a Karnofsky Performance Scores (KPS) of at least 70 at the first
post operative visit. Patients under 18 years of age must have a Lansky Performance
Score of of at least 70.
7. Patients must be able to undergo an MRI scan.
8. Patients must agree to randomization as documented by signing the Institutional
Review Board (IRB) approved consent form.
Exclusion Criteria:
1. Patients who have received prior radiation therapy to the brain for any reason.
2. There is radiographic evidence of leptomeningeal disease prior to study entry.
3. The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple
myeloma.
4. For females, if they are pregnant or breast-feeding (The exclusion is made because
gadolinium may be teratogenic in pregnancy).
Gender:
All
Minimum age:
4 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Start date:
August 13, 2009
Completion date:
April 30, 2025
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00950001
http://www.mdanderson.org
