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Radiation Therapy Following Surgery to Remove Brain Metastases

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
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
Brain and Central Nervous System Tumors
Procedure: radiation therapy
Procedure: stereotactic radiosurgery
Procedure: surgical procedure

MedlinePlus related topics:   Cancer   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   40
Study Start Date:   March 1997

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

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

  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
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Judith M. Ford, MD, PhD     Jonsson Comprehensive Cancer Center    
  More Information


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

Study ID Numbers:   CDR0000066270, UCLA-HSPC-970101503, UCLA-HSPC-970101502, NCI-G98-1416
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003320
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult tumors metastatic to brain  

Study placed in the following topic categories:
Neoplasm Metastasis
Central Nervous System Neoplasms
Nervous System Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Nervous System Diseases

ClinicalTrials.gov processed this record on September 19, 2008




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