Clinical Trials

Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

Location:

Trial status:

Inactive

Why is this study being done?

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.

Who is eligible to participate?

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

Last updated: 05/22/2012

NCT ID:

NCT00567970