Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

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: NCT00567970
Recruitment Status : Active, not recruiting
First Posted : December 5, 2007
Last Update Posted : November 17, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

December 4, 2007
December 5, 2007
November 17, 2017
April 2007
September 2018   (Final data collection date for primary outcome measure)
Maximum tolerated dose
Same as current
Complete list of historical versions of study NCT00567970 on Archive Site
  • Toxicity profile
  • Adverse events profile
  • Quality of life as measured by the Brief Pain Inventory and Brief Fatigue Inventory
  • Response profile
  • Physical exam results
Same as current
Not Provided
Not Provided
Stereotactic Radiation Therapy in Treating Patients With Liver Metastases
A Phase I Dose Finding Pilot Study of Stereotactic Body Radiotherapy for the Treatment of Liver Metastasis

RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with liver metastases.


  • To identify the maximum tolerated dose of stereotactic radiation therapy in patients with hepatic metastases.
  • To determine the toxicity and adverse events profile of this patient population.
  • To examine patient response, treatment effect on blood chemistry, and hematology values and patient quality-of-life in this patient population.

OUTLINE: Patients are stratified according to stereotactic radiotherapy level (1 vs 2 vs 3) and the number of liver lesions present (1-2 vs 3-5 vs > 5).

Patients undergo percutaneous placement of metallic fiducial markers within the liver for stereotactic targeting and planning. Patients then undergo 1 fraction of stereotactic radiotherapy within 1 week of the marker placement.

Patients complete Brief Pain Inventory and Brief Fatigue Inventory questionnaires to assess quality of life at weeks 2, 4, 6, 8 and months 3, 6, and 9 after completion of study treatment.

After completion of study treatment, patients are followed for at least 8 weeks.

Phase 1
Primary Purpose: Treatment
Metastatic Cancer
  • Procedure: quality-of-life assessment
  • Radiation: stereotactic body radiation therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
September 2018
September 2018   (Final data collection date for primary outcome measure)


  • Metastatic liver lesion ≤ 5 cm in dimension
  • Willing and able to undergo percutaneous placement of localization seeds


  • ECOG performance status 0-1
  • Life expectancy ≥ 12 weeks
  • Platelet count ≥ 75,000/µL
  • Hemoglobin ≥ 9 g/dL
  • ANC ≥ 1,500/mL
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • AST ≤ 3 x ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to complete questionnaires alone or with assistance
  • No medical, social, or economic circumstance, that is likely to prevent adherence with the protocol


  • No prior radiation therapy to the liver
  • No chemotherapy ≤ 4 weeks prior to registration
  • Able to safely go without chemotherapy for 4 weeks after stereotactic radiotherapy (e.g., patients must not have or need chemotherapy in the 8 weeks [4 weeks prior to and 4 weeks after registration] surrounding stereotactic radiotherapy
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
P30CA015083 ( U.S. NIH Grant/Contract )
MC0642 ( Other Identifier: Mayo Clinic Cancer Center )
06-004336 ( Other Identifier: Mayo Clinic IRB )
Not Provided
Not Provided
Mayo Clinic
Mayo Clinic
National Cancer Institute (NCI)
Principal Investigator: Laura A. Vallow, MD Mayo Clinic
Mayo Clinic
May 2017

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