Resection Bed Post-Surgical Stereotactic Radiosurgery (SRS) - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00950001

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 5-7 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: MRI Observed with routine post operative magnetic resonance imaging (MRI) scans only.	Procedure: MRI Standard MRI scans of the brain after surgery, at 5-7 weeks after surgery, every 6-9 weeks for a year, and then every 3-4 months after that. Other Names: MR MRI Scan

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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 at the time of the post operative magnetic resonance imaging (MRI). 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:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

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:	February 17, 2012
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 24, 2012