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.

Study Overview

• Status: Completed
• Conditions: Metastatic Cancer
• Intervention / Treatment: Procedure: quality-of-life assessment; Radiation: stereotactic body radiation therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic - Jacksonville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Maximum tolerated dose

Secondary Outcome Measures

Outcome Measure
Toxicity profile
Adverse events profile
Quality of life as measured by the Brief Pain Inventory and Brief Fatigue Inventory
Response profile
Physical exam results

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Laura A. Vallow, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2007
• Primary Completion (Actual): February 2, 2009
• Study Completion (Actual): April 21, 2016

Study Registration Dates

• First Submitted: December 4, 2007
• First Submitted That Met QC Criteria: December 4, 2007
• First Posted (Estimate): December 5, 2007

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: liver metastases
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: CDR0000579232; P30CA015083 (U.S. NIH Grant/Contract); MC0642 (Other Identifier: Mayo Clinic Cancer Center); 06-004336 (Other Identifier: Mayo Clinic IRB)