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Resection Bed Post-Surgical Stereotactic Radiosurgery (SRS)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00950001
First Posted: July 31, 2009
Last Update Posted: August 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  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.

Condition Intervention Phase
Brain Disease Procedure: Stereotactic Radiosurgery (SRS) Procedure: MRI Phase 3

Study Type: Interventional
Study Design: 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

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 ]
    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
Actual Study Start Date: August 2009
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2019 (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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
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).
  Contacts and Locations
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
  More Information

Additional Information:
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 Submitted: July 30, 2009
First Posted: July 31, 2009
Last Update Posted: August 3, 2017
Last Verified: August 2017

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


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