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

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Virginia Commonwealth University Identifier:
First received: November 6, 2000
Last updated: February 23, 2010
Last verified: February 2010

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 Intervention Phase
Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Radiation: stereotactic radiosurgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fractionated Stereotactic Body Radiosurgery for Extracranial Tumors

Resource links provided by NLM:

Further study details as provided by Virginia Commonwealth University:

Enrollment: 26
Study Start Date: February 1999
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
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.


Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Danny Song, MD, Virginia Commonwealth University/Massey Cancer Center Identifier: NCT00006456     History of Changes
Other Study ID Numbers: CDR0000068151, P30CA016059, MCV-MCC-9812-2C, NCI-V00-1612
Study First Received: November 6, 2000
Last Updated: February 23, 2010
Health Authority: United States: Federal Government

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 processed this record on November 25, 2015