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Radiation Therapy Following Surgery to Remove Brain Metastases
This study is ongoing, but not recruiting participants.
Study NCT00003320   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
March 1997
 
 
 
Complete list of historical versions of study NCT00003320 on ClinicalTrials.gov Archive Site
 
 
 
Radiation Therapy Following Surgery to Remove Brain Metastases
Pilot Study of Adjuvent Fractionated Stereotactic Radiotherapy Following Surgical Removal of Cerebral Metastases

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.

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.

 
Interventional
Treatment
Metastatic Cancer
  • Procedure: surgical procedure
  • Radiation: radiation therapy
  • Radiation: stereotactic radiosurgery
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
40
 
 

DISEASE CHARACTERISTICS: 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)

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 Pulmonary: No severe asthma requiring therapy Other: No allergy to iodine or contrast media Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy Endocrine therapy: Prior or concurrent required steroids allowed Radiotherapy: No prior whole brain irradiation or focal irradiation to current sites of disease Prior stereotactic radiotherapy of cerebral metastases allowed provided no prior irradiation of current surgical sites Surgery: Prior surgery of cerebral metastases allowed

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003320
 
CDR0000066270, UCLA-HSPC-970101503, UCLA-HSPC-970101502, NCI-G98-1416
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Judith M. Ford, MD, PhD Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
April 2002

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