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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT00960167
Eligibility Criteria:
Inclusion Criteria:
* Eligible patients include those with HCC based on the diagnostic criteria of European Association for the Study of the Liver (EASL), either confirmed cyto-histologically or confirmed non-invasively (restricted to cirrhotic patients) by radiological criteria (two coincident imaging techniques and focal lesion \> 2 cm with arterial hypervascularization) or combined criteria (one imaging technique associated with AFP, focal lesion \> 2 cm with arterial hypervascularization, and AFP levels \> 400 ng/ml).
* They have Child-Pugh grade A cirrhosis and are HBsAg-positive for more than 6 months.
* These patients are not feasible for other conventional treatment modalities of treatment including surgery, transarterial embolization, ethanol injection, and radiofrequency ablation.
* No systemic anti-cancer therapy with high priority is available.
* All of the above 3 criteria should be judged by the caring physician.
* All intrahepatic disease must be encompassed within the radiation fields, except intrahepatic diseases outside the radiation field(s) have been controlled by other treatment modalities before radiotherapy.
* Karnofsky Performance Scale ≧ 80.
* Age \> 18.
* Adequate bone marrow function, defined as follows:
* Absolute neutrophil count (ANC) \> 1,000 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to registration on study
* Platelets \> 20,000 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to registration on study
* Hemoglobin \> 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to registration on study (Note: The use of blood transfusion or other intervention to achieve Hgb \> 8.0 g/dl is acceptable.)
* Previous liver resection, embolization, or ablative therapy is permitted.
* Chemotherapy and/or targeted agent therapy must be completed at least 2 weeks prior to radiation.
* Women of childbearing potential and male participants must practice adequate contraception.
* Patient must sign informed consent prior to study entry.
* Pretreatment evaluations for eligibility include:
* A complete history and general physical examination
* For women of childbearing potential, a serum or urine pregnancy test must be performed within 72 hours prior to registration INR, total bilirubin, albumin, alkaline phosphatase, AST, ALT within 1 week prior to study entry
* At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
Exclusion Criteria:
* Prior invasive malignancy, other than HCC, (except nonmelanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
* Tumor thrombosis in the main trunk of portal vein, hepatic vein, or inferior vena cava.
* Child-Pugh grade B or C cirrhosis.
* Extrahepatic metastasis.
* Clinical ascites that requires diuretic treatment or paracentesis for symptom relief.
* Serum alanine aminotransferase (ALT) level \> 5X normal upper limits or total bilirubin level \> 3.0.
* Active hepatitis (serum ALT level \> 5X normal upper limits) or clinically significant liver failure.
* Positivity of anti-HCV, pregnancy, nursing women, or women of childbearing potential, and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00960167
Study Brief:
Protocol Section:
NCT00960167