Skip to main content
OpenTrials
Completed

NCT Number: NCT00006456

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

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Massey Cancer Center

Richmond, Virginia, 23298-0058, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stereotactic Radiosurgery

Radiation

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Fractionated Stereotactic Body Radiosurgery for Extracranial Tumors

Important dates

Study start
1999
Primary completion
2004
Study completion
2004
First posted
Jan 27, 2003
Registry last updated
Feb 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.