Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

This study is ongoing, but not recruiting participants.
Information provided by:
Mayo Clinic Identifier:
First received: December 4, 2007
Last updated: March 24, 2014
Last verified: March 2014

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.

Condition Intervention Phase
Metastatic Cancer
Procedure: quality-of-life assessment
Radiation: stereotactic body radiation therapy
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Dose Finding Pilot Study of Stereotactic Body Radiotherapy for the Treatment of Liver Metastasis

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Maximum tolerated dose [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity profile [ Designated as safety issue: Yes ]
  • Adverse events profile [ Designated as safety issue: Yes ]
  • Quality of life as measured by the Brief Pain Inventory and Brief Fatigue Inventory [ Designated as safety issue: No ]
  • Response profile [ Designated as safety issue: No ]
  • Physical exam results [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: April 2007
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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
  Contacts and Locations
Please refer to this study by its identifier: NCT00567970

United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Laura A. Vallow, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Laura A Vallow, M.D., Mayo Clinic in Florida Identifier: NCT00567970     History of Changes
Other Study ID Numbers: CDR0000579232, P30CA015083, MC0642, 06-004336
Study First Received: December 4, 2007
Last Updated: March 24, 2014
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
liver metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on April 20, 2014