Resection Bed Post-Surgical Stereotactic Radiosurgery (SRS)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: July 30, 2009
Last updated: February 17, 2016
Last verified: February 2016
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.

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: Parallel 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:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Primary analysis for TTLR is intent to treat analysis that A) will include all randomized patients; B) preserve the original treatment assignment; and C) is based on the stratified log-rank test.

Estimated Enrollment: 132
Study Start Date: August 2009
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic Radiosurgery (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:
  • MR
  • MRI Scan
Active Comparator: Magnetic Resonance Imaging (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:
  • MR
  • MRI Scan

  Show Detailed Description


Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00950001

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Anita Mahajan, MD M.D. Anderson Cancer Center
Principal Investigator: Ganesh Rao, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00950001     History of Changes
Other Study ID Numbers: 2009-0381  NCI-2011-00542 
Study First Received: July 30, 2009
Last Updated: February 17, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Brain tumors
Metastatic brain disease
Stereotactic radiosurgery
Whole brain radiotherapy
Magnetic Resonance Imaging
Outpatient radiation procedure

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on May 24, 2016