Trial record 2 of 3371 for:    Open Studies | "Brain Diseases"

Resection Bed Post-Surgical Stereotactic Radiosurgery (SRS)

This study is currently recruiting participants.
Verified February 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00950001
First received: July 30, 2009
Last updated: February 20, 2014
Last verified: February 2014
  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
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:


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 2016 (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

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
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
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, NCI-2011-00542
Study First Received: July 30, 2009
Last Updated: February 20, 2014
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 April 17, 2014