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Radiation Therapy Following Surgery to Remove Brain Metastases

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003320
First Posted: February 6, 2004
Last Update Posted: October 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
  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

Further study details as provided by Jonsson Comprehensive Cancer Center:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00003320     History of Changes
Other Study ID Numbers: CDR0000066270
P30CA016042 ( U.S. NIH Grant/Contract )
UCLA-HSPC-970101503
UCLA-HSPC-970101502
NCI-G98-1416
First Submitted: November 1, 1999
First Posted: February 6, 2004
Last Update Posted: October 30, 2015
Last Verified: July 2012

Keywords provided by Jonsson Comprehensive Cancer Center:
tumors metastatic to brain

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes