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:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT01862718
Eligibility Criteria:
* INCLUSION CRITERIA:
Patients with hepatic-dominant neoplasms where the life limiting component of the disease is hepatic neoplasms
Patients hepatic lesions must be considered technically unresectable or that their overall health makes surgery inadvisable
Have 5 or fewer lesions and with no single lesion greater than 10 cm in maximum diameter
Patients with extrahepatic neoplasms or an unresected primary lesion will be considered eligible if the extrahepatic disease is minimal and stable
Serum Creatinine less than or equal to 2.0 mg/dl unless the measured creatinine clearance is greater than 60 ml/min.
Absolute neutrophil count (ANC) greater than or equal to1500/m3 without help of Filgastim, hemoglobin greater than 8 g/dL, and platelet count greater than or equal to 75,000 m3
Bilirubin less than 3 mg/dl, and AST and ALT less than 5 X upper limit of normal except in the presence of obstructive liver neoplasms where ALT/AST may be up to 10 X the upper limit of normal.
Prothrombin Time (PT) within 2 seconds of the upper limit normal (INR less than or equal to 1.5)
Patient on oral, SQ or IV anticoagulants will be expected to have an abnormal PT and will be considered eligible if they can safely dicontinue the anticoagulant before ablation. A repeat PT will be obtained at least 24 hours prior to the radiofrequency ablation (only) and should be within practice safety guidelines of an INR less than 1.5 or if greater than 1.5 have clinical reversal agent as appropriate to the anticoagulant administered.
Extent of hepatic neoplasms is approximately less than 60% of total hepatic volume
Patients must have pathology proof of neoplasm. If proof of pathology is unavailable, histopathological confirmation of liver neoplasm may not be requisite in the setting of clinical or radiological characteristics that are highly suggestive of a neoplastic diagnosis, with such designation determined by PI and a medical or surgical oncologist, with the NCI multidisciplinary gastrointestinal tumor board review, in the event of absence of such consensus.
Patients referred for ablation or radiation of liver neoplasm
ECOG performance status less than or equal to 2
Life expectancy greater than 3 months
At least 18 years of age
Age less than 85 years
Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their malignancy for at least 28 days prior to treatment and must have recovered from all clinically significant side effects of therapeutic and diagnostic interventions.
EXCLUSION CRITERIA:
Portal Vein Occlusion or other contraindications to thermal ablation or radiation Prior selective internal radiation therapy (SIRT) with Yttrium-90 or prior radiation to the liver
Prior biliary diversion surgery
Patients with active bacterial infections with systemic manifestations (malaise, fever, leukocytosis) are not eligible until completion of appropriate therapy.
Any exclusion criteria for radiation or for ablation, such as ataxia telangiectasia, active connective tissue disease, or inflammatory bowel disease, or other known conditions which predispose to radiation toxicities
Patients with an acute, critical illness
Pregnant women are excluded from the study. Patients are excluded from pregnancy testing if they are above the childbearing age of 55 years old, or if they have documented history of infertility or acquired or congenital disorders incompatible with pregnancy or if the patient has had a hysterectomy or bilateral oophorectomy. Patients are also excluded from pregnancy testing if they are at least 50 years of age AND have not menstruated for at least 12 months OR have a documented Follicle Stimulating Hormone (FSH) level of greater than 40 mIU/mL.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01862718
Study Brief:
Protocol Section:
NCT01862718