Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-24 @ 6:45 PM
NCT ID:
NCT00938457
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00938457
Study Brief:
Protocol Section:
NCT00938457