Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

Metastatic Cancer Clinical Trial

Official title:

A Phase I Dose Finding Pilot Study of Stereotactic Body Radiotherapy for the Treatment of Liver Metastasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567970
• Other study ID #: CDR0000579232
• Secondary ID: P30CA015083MC064
• Status: Completed
• Phase: Phase 1
• Start date: April 2, 2007
• Est. completion date: April 21, 2016

Study information

• Verified date: October 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: April 21, 2016
• Est. primary completion date: February 2, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Procedure:
• quality-of-life assessment

Radiation:
• stereotactic body radiation therapy

Locations

Country	Name	City	State
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose
Secondary	Toxicity profile
Secondary	Adverse events profile
Secondary	Quality of life as measured by the Brief Pain Inventory and Brief Fatigue Inventory
Secondary	Response profile
Secondary	Physical exam results