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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006456
First Posted: January 27, 2003
Last Update Posted: February 24, 2010
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:
Virginia Commonwealth University
  Purpose

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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fractionated Stereotactic Body Radiosurgery for Extracranial Tumors

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:

OBJECTIVES:

  • 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.

  Eligibility

Information from the National Library of Medicine

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

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

Renal:

  • Creatinine less than 2.0 mg/dL

Pulmonary:

  • FEV1 greater than 0.75 L

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • At least 14 days since prior anticancer chemotherapy and recovered

Endocrine therapy:

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

Radiotherapy:

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

Surgery:

  • Not specified
  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): NCT00006456


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

Responsible Party: Danny Song, MD, Virginia Commonwealth University/Massey Cancer Center
ClinicalTrials.gov Identifier: NCT00006456     History of Changes
Other Study ID Numbers: CDR0000068151
P30CA016059 ( U.S. NIH Grant/Contract )
MCV-MCC-9812-2C
NCI-V00-1612
First Submitted: November 6, 2000
First Posted: January 27, 2003
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
Neoplasms
Pathologic Processes