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Resection Bed Post-Surgical Stereotactic Radiosurgery (SRS)

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ClinicalTrials.gov Identifier: NCT00950001
Recruitment Status : Active, not recruiting
First Posted : July 31, 2009
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Brain Disease Procedure: Stereotactic Radiosurgery (SRS) Procedure: MRI Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Post-Surgical Stereotactic Radiosurgery for Metastatic Brain Disease: A Randomized Trial
Actual Study Start Date : August 2009
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
    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.



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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950001


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Erik P. Sulman, MD,PHD M.D. Anderson Cancer Center
Principal Investigator: Ganesh Rao, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00950001     History of Changes
Other Study ID Numbers: 2009-0381
NCI-2011-00542 ( Registry Identifier: NCI CTRP )
First Posted: July 31, 2009    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No

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