Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

NCT ID: NCT00938457

Last Updated: 2016-05-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31

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/II trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with liver metastases.

Detailed Description

OUTLINE: This is a phase I/II, dose-escalation study.

Phase I: Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.

Phase II: Patients undergo treatment as in phase I at the maximum tolerated dose. After completion of study treatment, patients will be followed at weeks 4 and 12 and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Conditions

Unspecified Adult Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.

Group Type: EXPERIMENTAL

stereotactic radiation therapy

Intervention Type: RADIATION

Patients undergo stereotactic body radiation therapy

implanted fiducial-based imaging

Intervention Type: PROCEDURE

radiation therapy treatment planning

cone-beam computed tomography

Intervention Type: PROCEDURE

radiation therapy treatment planning

Interventions

stereotactic radiation therapy

Patients undergo stereotactic body radiation therapy

Intervention Type: RADIATION

implanted fiducial-based imaging

radiation therapy treatment planning

Intervention Type: PROCEDURE

cone-beam computed tomography

radiation therapy treatment planning

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Histological confirmation (any histology except lymphoma, leukemia, or hepatocellular carcinoma) of at least one liver lesion that is synchronous to the primary diagnosis of malignancy or metachronous as a recurrence/metastasis or as a failure following previous therapy (except radiotherapy).
• One to three metastatic liver lesions =< 5 cm in dimension.
• Intrahepatic cholangiocarcinoma is acceptable for inclusion.
• Zubrod Performance Status (PS) 0 or 1.
• Please contact study investigator and/or consult protocol document for specific details on laboratory criteria.
• Life expectancy >= 12 weeks.
• MELD (Model for End-Stage Liver Disease) score =< 16.
• >= 1000 cc of uninvolved liver parenchyma as determined by the treating physician.
• Determination that the patient is medically inoperable and/or unwilling to undergo liver resection in patients with colorectal carcinoma histology.
• Provide informed written consent.
• Willingness to return to Mayo Clinic Rochester for follow-up.

Exclusion Criteria

• Pregnant women.
• Nursing women.
• Men or women of childbearing potential or their partners who are unwilling to employ adequate contraception.
• Co-morbid systemic illnesses or other severe concurrent disease, defined as those which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< 7 days prior to registration.
• Administration of chemotherapy within 2 wks prior to or 2 wks following SF-SBRT.
• Prior radiation therapy to the liver Untreated malignant biliary obstruction (patients treated successfully with stenting are eligible).
• Current diagnosis of hepatocellular carcinoma

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

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert C. Miller, M.D.

Role: STUDY_CHAIR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

MC0941

Identifier Type: OTHER

Identifier Source: secondary_id

09-000020

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2009-01150

Identifier Type: REGISTRY

Identifier Source: secondary_id

MC0941

Identifier Type: -

Identifier Source: org_study_id