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Radiation Therapy With or Without Surgery in Treating Patients Who Have Brain Metastases
This study is ongoing, but not recruiting participants.
Study NCT00003324   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: August 29, 2009   History of Changes

November 1, 1999
August 29, 2009
December 1998
 
 
 
Complete list of historical versions of study NCT00003324 on ClinicalTrials.gov Archive Site
 
 
 
Radiation Therapy With or Without Surgery in Treating Patients Who Have Brain Metastases
Prognostic Factors Associated With Successful Omission of Whole Brain Radiotherapy in Patients With 4 or Less Cerebral Metastases Treated With Focal Radiation or Surgery

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.

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.

 
Interventional
Treatment
Metastatic Cancer
  • Procedure: conventional surgery
  • Radiation: radiation therapy
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
60
 
 

DISEASE CHARACTERISTICS:

  • 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
  • No more than four cerebral metastases on MRI scan and suitable for focal treatment with surgery and/or stereotactic radiotherapy with a linear accelerator
  • Refused whole brain radiation therapy OR
  • Received prior whole brain radiation therapy and ineligible for other relapse protocols

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Concurrent steroids allowed

Radiotherapy:

  • No more than 2 weeks since prior focal radiation
  • See Disease Characteristics

Surgery:

  • No more than 2 weeks since prior focal surgery
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003324
 
CDR0000066275, UCLA-HSPC-9710074, UCLA-HSPC-971007401, NCI-G98-1417
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Judith M. Ford, MD, PhD Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
September 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP