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:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
NCT ID:
NCT01360606
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients ≥ 18 years of age
* A life expectancy of at least 6 months with a Karnofsky performance status of at least 70
* The target lesion(s) can be accurately measured in at least one dimension according to RECIST and must have a maximum tumor volume of ≤ 100 cm3
* No prior radiotherapy to the upper abdomen
* Previous systemic chemotherapy or non-radiation local therapy (such as surgery, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation) is allowed. The lesion must however have shown criteria of progression based on RECIST. Local therapy must be completed at least 4 weeks prior to the baseline scan. This is to create a safer treatment environment and to help determine the effect of treatment by SBRT alone. Patients will be allowed to go onto appropriate systemic therapy, as determined by their medical oncologist, 2 weeks following delivery of SBRT
* Patients with resectable disease will be eligible for participation if they have comorbidities precluding surgery or refuse to undergo an operation
* Cirrhotic status of Child-Pugh class A or B
* Patients can have extra-hepatic disease, provided the hepatic disease is the highest burden, the extra-hepatic disease is low burden and potentially treatable with surgery, ablative radiation therapy, or US Food and Drug Administration-approved first- or second-line systemic therapy regimens
* Patient's will have no evidence of gross vascular invasion.
* Patients will have no more than 3 distinct lesions, all being ≤ 3cm in greatest dimension, OR 1 lesion ≤ 6cm in greatest dimension
* Platelet count ≥ 60 x 109/L, Hemoglobin ≥ 8.5 g/dL, WBC ≥ 2000/μL International normalized ratio (INR) must be ≤ 2.3. Patients who are being therapeutically anticoagulated with an agent such as Coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists
* Other baseline labs must meet the following criteria: total bilirubin \< 3mg/dl, albumin\> 2.5mg/dl, and liver enzymes less than three times the upper limit of normal. Creatinine must also be \< 1.8mg/dl or a creatinine clearance \> 50ml/min
* Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts
Exclusion Criteria:
* Renal failure requiring hemo- or peritoneal dialysis
* Uncontrolled inter-current illness including, but not limited to ongoing or active infection (\> grade 2 National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events \[CTCAE\] version 4.0), congestive heart failure (\> New York Heart Association (NYHA) class 2), active coronary artery disease (CAD), cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), uncontrolled hypertension and any condition which could jeopardize the safety of the patient and his/her compliance in the study . Myocardial infarction more than 6 months prior to study entry is permitted
* A history of variceal bleeding where the varices have not been eradicated or decompressed by shunt placement
* History of an active connective tissue disorder
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
* Pregnant or breast-feeding patients are excluded from this study because abdominal radiation therapy has potential for teratogenic and/or abortifacient effects
* Portal vein occlusion
* Extensive liver tumor burden, defined as more than 75% of the liver.
* Patients with primary tumor histology of lymphoma, leukemia, or germ cell tumor
* Patients with hepatocellular carcinoma will be excluded from this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01360606
Study Brief:
Protocol Section:
NCT01360606