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 @ 7:04 PM
Ignite Modification Date:
2025-12-24 @ 7:04 PM
NCT ID:
NCT01030757
Eligibility Criteria:
Inclusion Criteria:
* Histologic confirmation of solid primary tumor metastatic to liver
* Age greater than or equal to 18 years old
* Zubrod performance status less than or equal to 1
* Negative pregnancy test for women of child bearing potential
* Informed consent
* Less than or equal to 3 liver metastases
* Each lesion must be less than or equal to 6 cm in maximal diameter
* No prior radiation to lesions being treated
* Patient is not a surgical candidate or refuses surgery
* Absolute neutrophil count ≥ 1800
* Platelets ≥ 100000
* Hemoglobin ≥8.0
* Systemic therapy (chemotherapy) completed at least 2 weeks prior to SBRT
* At time of radiation treatment planning, at least 700 cc of normal liver must receive less than 15 Gy
Exclusion Criteria:
* Contraindications to radiation
* Pregnant or lactating females who chose to breast feed
* Patients must have recovered from toxicity of prior therapy
* Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications
* Patients currently receiving anticoagulation with coumadin or IV heparin
* Liver cirrhosis
* Clinical ascites
* Bilirubin \> 3, Albumin \< 2.5, liver enzymes 3 times above normal, Creatinine \> 1.8
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01030757
Study Brief:
Protocol Section:
NCT01030757