Radiation Therapy Following Surgery to Remove Brain Metastases - Full Text View

Sponsor:	University of California, Los Angeles
Collaborator:	National Cancer Institute (NCI)
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00003320

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy after surgery to remove brain metastases may decrease the amount of radiation required to treat brain metastases.

PURPOSE: Pilot trial to study the effectiveness of radiation therapy following surgery to remove brain metastases.

Condition	Intervention
Metastatic Cancer	Procedure: surgical procedure Radiation: radiation therapy Radiation: stereotactic radiosurgery

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Pilot Study of Adjuvant Fractionated Stereotactic Radiotherapy Following Surgical Removal of Cerebral Metastases

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Enrollment:	20
Study Start Date:	March 1997
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES: I. Assess the safety and tolerability of focal stereotactic radiotherapy to the surgical bed following excision of cerebral metastases, as an alternative to whole brain irradiation. II. Measure the local relapse rate at the surgical site after surgery and stereotactic radiotherapy in patients with cerebral metastases. III. Measure the regional relapse rate, in the brain but away from the treated site, following treatment in these patients.

OUTLINE: All patients undergo surgical removal of their cerebral metastases followed by adjuvant fractionated stereotactic radiotherapy daily for 5 days. Patients are given up to 5 weeks following surgery to recover and reach the required performance status. Radiotherapy must commence within 6 weeks of surgery. Patients are followed at 2 weeks after treatment, monthly for 6 months, every 3 months for the next 18 months, every 6 months for the next year, and then annually for years 3-5.

PROJECTED ACCRUAL: There will be 20-40 patients accrued into this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed cerebral metastases post surgical resection
No greater than 3 cerebral metastases postresection
Gross resection at operation as documented in operation note and postoperative MRI Patients must have current surgical sites that have not been previously irradiated
No other indication for whole brain irradiation (i.e., multiple untreated metastases not suitable for single fraction stereotactic radiotherapy, leptomeningeal disease)
Age: 18 and over
Karnofsky 60-100%
Life expectancy: At least 3 months
Prior or concurrent required steroids allowed
Prior stereotactic radiotherapy of cerebral metastases allowed provided no prior irradiation of current surgical sites
Prior surgery of cerebral metastases allowed

Exclusion Criteria:

severe asthma requiring therapy
allergy to iodine or contrast media
pregnant
concurrent chemotherapy
prior whole brain irradiation or focal irradiation to current sites of disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003320

Locations

United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781

Sponsors and Collaborators

University of California, Los Angeles

National Cancer Institute (NCI)

Investigators

Study Chair:

Judith M. Ford, MD, PhD

Jonsson Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Judith Ford, University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00003320 History of Changes
Other Study ID Numbers:	CDR0000066270, P30CA016042, UCLA-HSPC-970101503, UCLA-HSPC-970101502, NCI-G98-1416
Study First Received:	November 1, 1999
Last Updated:	April 13, 2011
Health Authority:	United States: Federal Government

Keywords provided by University of California, Los Angeles:

tumors metastatic to brain

Additional relevant MeSH terms:

Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012