Stereotactic Radiosurgery in Treating Patients With Liver Metastases, Lung Metastases, or Other Advanced Solid Tumors

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. Identifier: NCT00006456
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 24, 2010
National Cancer Institute (NCI)
Information provided by:
Virginia Commonwealth University

Brief Summary:

RATIONALE: Stereotactic radiosurgery delivers x-rays directly to the tumor and may cause less damage to normal tissue.

PURPOSE: Phase II trial to study the effectiveness of stereotactic radiosurgery in treating patients who have liver metastases, lung metastases, or other advanced solid tumors.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific Radiation: stereotactic radiosurgery Phase 2

Detailed Description:


  • Determine the feasibility of fractionated stereotactic body radiosurgery in patients with advanced extracranial tumors.
  • Assess the toxicities of this treatment regimen in these patients.
  • Determine tumor response and cause of death in these patients treated with this regimen.

OUTLINE: Patients receive fractionated stereotactic body radiosurgery over 30 minutes for 5-10 days for a total of 3 treatments.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 10-25 patients will be accrued within 2-3 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fractionated Stereotactic Body Radiosurgery for Extracranial Tumors
Study Start Date : February 1999
Primary Completion Date : November 2004
Study Completion Date : November 2004

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed malignancy

    • Extracranial recurrent or metastatic disease or primary tumor not predicted to be controlled with standard radiotherapy
    • Incurable with any standard therapy
  • No tumors involving critical structures (e.g., mucosal surfaces (bowel or bladder) or heart)
  • Tumor visible by CT scan



  • Not specified

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified


  • Not specified


  • Bilirubin less than 2.0 times upper limit of normal (ULN)
  • AST and ALT less than 5 times ULN


  • Creatinine less than 2.0 mg/dL


  • FEV1 greater than 0.75 L


  • No unsuitable size or geometric proportion that would preclude stereotactic immobilization
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy:

  • At least 14 days since prior anticancer biologic therapy and recovered


  • At least 14 days since prior anticancer chemotherapy and recovered

Endocrine therapy:

  • At least 14 days since prior anticancer endocrine therapy and recovered


  • See Disease Characteristics
  • At least 14 days since prior anticancer radiotherapy and recovered


  • Not specified

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 identifier (NCT number): NCT00006456

United States, Virginia
Massey Cancer Center
Richmond, Virginia, United States, 23298-0058
Sponsors and Collaborators
Virginia Commonwealth University
National Cancer Institute (NCI)
Study Chair: Danny Y. Song, MD Massey Cancer Center

Responsible Party: Danny Song, MD, Virginia Commonwealth University/Massey Cancer Center Identifier: NCT00006456     History of Changes
Other Study ID Numbers: CDR0000068151
P30CA016059 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 24, 2010
Last Verified: February 2010

Keywords provided by Virginia Commonwealth University:
unspecified adult solid tumor, protocol specific
lung metastases
liver metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes