MDACC Study Summary 2009-0381

Study Summary
No. 2009-0381:.......Brain......Anita Mahajan......Radiation Oncology

Study Summary Title



Study Summary Number:	2009-0381

Study Title:	Efficacy of Post-Surgical Stereotactic Radiosurgery for Metastatic Brain Disease: A Randomized Trial

Physician

New Patient Referral



Name:	Anita Mahajan	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Radiation Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-2300 Contact us about clinical trials

General Information



Disease Group:	Brain	Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	All patients will be undergo an MRI at 5-7 wks post craniotomy then every 6-9 wks for 1 year, then every 3 - 4 months thereafter. Patients will be removed from the study once

Treatment Agents:	Stereotactic Radiosurgery	Home Care:	n/a

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	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.

Study Objectives / Outcomes

1. 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.
2. Secondary endpoints assessed will include: overall survival, development of distant brain metastases and complications related to treatment .

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	08/13/2009

Study Type:	Phase Iii

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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

Links

Registration Number: NCT00950001
Study Information on Clinical Trials Registry (clinicaltrials.gov)