Radiation Therapy With or Without Surgery in Treating Patients Who Have 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:	NCT00003324

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells in a single high dose. Combining radiation therapy with surgery may be a more effective treatment for brain metastases.

PURPOSE: Clinical trial to study the effectiveness of radiation therapy with or without surgery in treating patients who have brain metastases.

Condition	Intervention
Metastatic Cancer	Procedure: conventional surgery Radiation: radiation therapy

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Prognostic Factors Associated With Successful Omission of Whole Brain Radiotherapy in Patients With 4 or Less Cerebral Metastases Treated With Focal Radiation or Surgery

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:	61
Study Start Date:	December 1997
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Develop prognostic factors for patients with brain metastases treated by focal treatment without concurrent whole brain irradiation.
Determine whether focal treatment without whole brain radiotherapy produces good long-term outcome in patients with four or less cerebral metastases.
Assess survival, physical and cognitive functioning, and quality of life of patients treated on this protocol.

OUTLINE: Quality of life is assessed using the FACT-BR scale, physical function is assessed using the FIM scale, and cognition is assessed using two brief pencil and paper tests.

Patients receive focal therapy for cerebral metastases by any combination of (1) surgery plus fractionated stereotactic radiotherapy to surgical bed, or (2) single fraction stereotactic radiotherapy by linear accelerator with or without a radiation sensitizer.

Patients are followed at 2 and 10 weeks, then every 3 months for 18 months, then every 6 months for 3 years, then annually. Quality of life is assessed at each followup visit.

Patients suffering intracerebral relapse are offered further focal therapy if they have no more than 3 metastases, no more than 6 lesions over consecutive scans, and continue to have life expectancy of at least 3 months and Karnofsky performance status of 60-100%. Otherwise, relapsed patients are offered whole brain radiotherapy or supportive treatment with steroids, and may also receive stereotactic boost to the new lesions. Patients who have received prior whole brain irradiation will be offered entry into other protocols if eligible or supportive treatment with steroids. Patients are followed as above.

PROJECTED ACCRUAL: At least 60 patients will be enrolled in this study.

Eligibility

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

Criteria

Inclusion Criteria:

Biopsy, CT scan, or MRI proven cerebral metastases with known current or previous systemic malignancy OR
Biopsy proven cerebral metastases other than from small cell lung cancer or lymphoma
Refused whole brain radiation therapy OR
Received prior whole brain radiation therapy and ineligible for other relapse protocols
18 and over
Karnofsky 60-100%
Life expectancy:At least 3 months
Concurrent steroids allowed

Exclusion Criteria:

more than four cerebral metastases on MRI scan and suitable for focal treatment with surgery and/or stereotactic radiotherapy with a linear accelerator
more than 2 weeks since prior focal radiation
more than 2 weeks since prior focal surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003324

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

Publications:

Chitapanarux I, Goss B, Vongtama R, Frighetto L, De Salles A, Selch M, Duick M, Solberg T, Wallace R, Cabatan-Awang C, Ford J. Prospective study of stereotactic radiosurgery without whole brain radiotherapy in patients with four or less brain metastases: incidence of intracranial progression and salvage radiotherapy. J Neurooncol. 2003 Jan;61(2):143-9.

Responsible Party:	Judith Ford, University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00003324 History of Changes
Other Study ID Numbers:	CDR0000066275, P30CA016042, UCLA-HSPC-9710074, UCLA-HSPC-971007401, NCI-G98-1417
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