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Stereotactic Radiosurgery in Treating Patients With Liver Metastases, Lung Metastases, or Other Advanced Solid Tumors
This study is ongoing, but not recruiting participants.
Study NCT00006456   Information provided by National Cancer Institute (NCI)
First Received: November 6, 2000   Last Updated: February 6, 2009   History of Changes

November 6, 2000
February 6, 2009
February 1999
 
 
 
Complete list of historical versions of study NCT00006456 on ClinicalTrials.gov Archive Site
 
 
 
Stereotactic Radiosurgery in Treating Patients With Liver Metastases, Lung Metastases, or Other Advanced Solid Tumors
Fractionated Stereotactic Body Radiosurgery for Extracranial Tumors

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.

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.

Phase II
Interventional
Treatment
  • Metastatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
Radiation: stereotactic radiosurgery
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006456
 
CDR0000068151, MCV-MCC-9812-2C, NCI-V00-1612
Massey Cancer Center
 
Study Chair: Danny Y. Song, MD Massey Cancer Center
National Cancer Institute (NCI)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP