Resection Bed Post-Surgical Stereotactic Radiosurgery (SRS)
This study is currently recruiting participants.
Verified May 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00950001
First received: July 30, 2009
Last updated: May 2, 2013
Last verified: May 2013
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Purpose
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.
Objectives:
- 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 endpoints assessed will include: overall survival, development of distant brain metastases and complications related to treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Disease |
Procedure: Stereotactic Radiosurgery (SRS) Procedure: MRI |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy of Post-Surgical Stereotactic Radiosurgery for Metastatic Brain Disease: A Randomized Trial |
Resource links provided by NLM:
MedlinePlus related topics:
Brain Cancer
Brain Diseases
Cancer
Childhood Brain Tumors
MRI Scans
Nuclear Scans
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Time to Local Recurrence (TTLR) [ Time Frame: Differences in TTLR will be monitored at 3 timepoints and will take place: 1) after a total of 39 events occur; 2) after 77 events occur; and 3) after at least 115 events occur. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 132 |
| Study Start Date: | August 2009 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SRS
Receive stereotactic radiosurgery (SRS) to area of brain where metastasis removed.
|
Procedure: Stereotactic Radiosurgery (SRS)
1 day outpatient radiation procedure using stereotactic frame to target radiotherapy to surgical area found by MRI scan.
Procedure: MRI
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.
Other Names:
|
|
Active Comparator: MRI
Observed with routine post operative magnetic resonance imaging (MRI) scans only.
|
Procedure: MRI
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.
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 3 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must be older than 3 years of age (radiosurgical frames cannot be placed on children younger than age 3).
- 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.
- The resection cavity must have a maximum diameter of less than or equal to 4cm. This criteria will be determined by the study radiologist.
- Additional unresected brain metastases (up to 2) must have a maximum diameter of less than or equal to 3 cm.
- Patients must be considered candidates for SRS within 30 days of surgical resection.
- 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.
- Patients must be able to undergo an MRI scan.
- Patients must agree to randomization as documented by signing the Institutional Review Board (IRB) approved consent form.
Exclusion Criteria:
- Patients who have received prior radiation therapy to the brain for any reason.
- There is radiographic evidence of leptomeningeal disease prior to study entry.
- The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma.
- For females, if they are pregnant or breast-feeding (The exclusion is made because gadolinium may be teratogenic in pregnancy).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00950001
Contacts
| Contact: Anita Mahajan, MD | 713-563-2300 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Anita Mahajan, MD | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Anita Mahajan, MD | UT MD Anderson Cancer Center |
| Principal Investigator: | Ganesh Rao, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00950001 History of Changes |
| Other Study ID Numbers: | 2009-0381 |
| Study First Received: | July 30, 2009 |
| Last Updated: | May 2, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Brain tumors Metastatic brain disease Post-surgical Stereotactic radiosurgery SRS |
Whole brain radiotherapy MRI Magnetic Resonance Imaging Outpatient radiation procedure |
Additional relevant MeSH terms:
|
Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013