MDACC Study Summary ID00-377

Study Summary
No. ID00-377:.............Eric L. Chang......Radiation Oncology

Study Summary Title



Study Summary Number:	ID00-377

Study Title:	A Phase III Prospective Randomized Trial Comparing Radiosurgery with Versus without Whole Brain Radiotherapy for 1-3 Newly Diagnosed Brain Metastases

Physician

New Patient Referral



Name:	Eric L. Chang	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:		Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	During the study, all patients will undergo follow-up evaluation and MRI scanning at post-treatment months 1,2,4,6,9,12,15,18 and every 6 months thereafter by the staffs of radiation oncology, neurosurgery, and neuropsychology.

Treatment Agents:		Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A. All treatments are to be performed on an outpatient basis.


Description/ Intervention:	The goal of this clinical research study is to learn if your thinking ability (cognitive function) will be better preserved by delivering whole brain radiation therapy immediately after radiosurgical treatment of 1-3 brain metastases or to carefully observe patients after radiosurgery and hold back whole brain radiation therapy until the disease comes back.

Study Objectives / Outcomes

1. To compare survival in a prospective randomized trial of patients with 1-3 brain metastases treated with either radiosurgery and whole brain radiation therapy or radiosurgery alone.
2. To prospectively compare the rates of local and distant brain recurrence between the two treatment groups.
3. To formally assess and compare neurocognitive changes and quality of life between the two treatment groups.
4. To determine after observation, when local salvage is an option, whether salvage therapy with local therapy (radiosurgery and/or surgery) can produce rates of freedom from progression comparable to WBRT by randomizing salvage therapy to be either local therapy or WBRT.
5. To use functional MRI to assess short-term memory by showing neuronal activation during picture recognition and to conduct dynamic susceptibility contrast-enhanced MRI to detect reductions in cerebral blood flow and blood volume that will allow monitoring of hemodynamic changes associated related to WBRT and metastatic brain disease.
6. To perform cost-utility analysis on randomized patients

Study Status Information



Study Activation / Registration Date:	01/02/2001

IRB Review and Approval Date:	12/20/2000

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	48 per year

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:

Unavailable

Exclusion Criteria:

Unavailable

Links

Registration Number: NCT00548756
Study Information on Clinical Trials Registry (clinicaltrials.gov)