This trial is active, not recruiting.

Condition brain disease
Treatments stereotactic radiosurgery (srs), mri
Phase phase 3
Sponsor M.D. Anderson Cancer Center
Start date August 2009
End date August 2017
Trial size 132 participants
Trial identifier NCT00950001, 2009-0381, NCI-2011-00542


The goal of this clinical research study is to learn if stereotactic radiosurgery can help to reduce the risk of a brain tumor returning after surgery. The safety of this treatment will also be studied.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Receive stereotactic radiosurgery (SRS) to area of brain where metastasis removed.
stereotactic radiosurgery (srs)
1 day outpatient radiation procedure using stereotactic frame to target radiotherapy to surgical area found by MRI scan.
mri MR
Standard MRI scans of the brain after surgery, at 5-8 weeks after surgery, every 6-9 weeks for a year, and then every 3-4 months after that.
(Active Comparator)
Observed with routine post operative magnetic resonance imaging (MRI) scans only.
mri MR
Standard MRI scans of the brain after surgery, at 5-8 weeks after surgery, every 6-9 weeks for a year, and then every 3-4 months after that.

Primary Outcomes

Time to Local Recurrence (TTLR)
time frame: MRI of brain 5-8 weeks after surgery, every 6-9 weeks for a year and then every 3-4 months for a year, then every 6 months till recurrence

Eligibility Criteria

Male or female participants at least 3 years old.

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).

Additional Information

Official title Efficacy of Post-Surgical Stereotactic Radiosurgery for Metastatic Brain Disease: A Randomized Trial
Principal investigator Anita Mahajan, MD
Description After surgery to remove brain metastasis, patients are usually given whole brain radiotherapy because of the risk of the tumor regrowing in that area or in other places in the brain. It is given in 10-14 daily sessions over 2-3 weeks. Because of the potential side effects of whole brain radiotherapy, stereotactic radiosurgery to the area of the brain with metastasis or observation is also used. This study will be using stereotactic radiosurgery or observation instead of whole brain radiotherapy. Stereotactic radiosurgery is a highly focused, 1 day outpatient radiation procedure. Observation is checking the brain through repeat magnetic resonance imagine (MRI) scans, but performing no treatment. Study Groups: If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. - Group 1 will receive stereotactic radiosurgery to the area of the brain that had the brain metastasis removed. - Group 2 will be observed with routine MRI scans only. You will have an equal chance of being assigned to either group. Stereotactic Radiosurgery: Stereotactic radiosurgery will be offered for treatment of any tumor that was not removed by surgery whether or not you are randomized to treatment of the surgical bed or not. If you are assigned to receive stereotactic radiosurgery, your neurosurgeon and radiation oncologist will discuss the procedure with you in detail. You will also sign a separate consent form, which will include the potential risks. Stereotactic radiosurgery requires the placement of a stereotactic head frame, which is a ring attached to the head with 4 small pins. The frame placement is done with local anesthetic (numbing medicine) by the neurosurgeon on the day of the procedure and will remain in place until the end of the stereotactic radiosurgery later in the day. The stereotactic frame will help the doctor to target the radiotherapy to the area of the surgery that was found by an MRI scan. The surgical area and up to 2 other lesions will be treated. Study Visits: You will have standard MRI scans of the brain after surgery, at 5-8 weeks after surgery, every 6-9 weeks for a year and then every 3-4 months for a year, then every 6 months after that. At these times, the area of surgery and any other brain tumors that were treated will be evaluated for regrowth or side effects from the treatment. The doctors will also decide whether there are any new lesions that require treatment. Length of Study: You will be considered to be off study if the tumor has returned to the surgery site or if whole brain radiotherapy is used. Additional Information: If an MRI scan indicates that the tumor has returned or a new lesion has occurred in the brain, you and your doctor will discuss other treatment options including surgery, stereotactic radiosurgery, whole brain radiotherapy, or chemotherapy. This is an investigational study. Stereotactic radiosurgery is FDA approved and commercially available. The comparison of stereotactic radiosurgery to observation is investigational. Up to 132 patients will take part in this study. All will be enrolled at MD Anderson.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.
Location data was received from the National Cancer Institute and was last updated in July 2016.