Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00567970
First received: December 4, 2007
Last updated: March 24, 2014
Last verified: March 2014

December 4, 2007
March 24, 2014
April 2007
September 2014   (final data collection date for primary outcome measure)
Maximum tolerated dose [ Designated as safety issue: Yes ]
Maximum tolerated dose
Complete list of historical versions of study NCT00567970 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Toxicity profile
  • Adverse events profile
  • Quality of life as measured by the Brief Pain Inventory and Brief Fatigue Inventory
  • Response profile
  • Physical exam results
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.

OBJECTIVES:

  • 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.

Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
18
Not Provided
September 2014   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00567970
CDR0000579232, P30CA015083, MC0642, 06-004336
Yes
Laura A Vallow, M.D., Mayo Clinic in Florida
Mayo Clinic
National Cancer Institute (NCI)
Principal Investigator: Laura A. Vallow, MD Mayo Clinic
Mayo Clinic
March 2014

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