Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

NCT ID: NCT00567970

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-02
• Study Completion Date: 2016-04-21

Brief 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.

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.

Conditions

Metastatic Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

quality-of-life assessment

Intervention Type: PROCEDURE

stereotactic body radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura A. Vallow, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MC0642

Identifier Type: OTHER

Identifier Source: secondary_id

06-004336

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000579232

Identifier Type: -

Identifier Source: org_study_id