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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT00777894
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically, cytologically, or radiologically confirmed hepatocellular carcinoma
* Clinical stage T2-4, N0-1, M0 (stage II, IIIA, IIIB, IIIC) OR unresectable T1, N0-1, M0 (stage I) disease
* M1 disease allowed in phase I if at least 90% of the tumor load (volume) is in the liver
* Measurable disease (at least one liver lesion that can be measured in at least one dimension as ≥ 10 mm in multislice CT scan/MRI)
* Volumetry of liver tumor and residual liver tissue: residual liver volume (= total liver volume - gross tumor volume) has to be ≥ 800 mL and ≥ 40% of total liver volume
* No operable disease (with curative intent or planned liver transplantation)
* No presence of clinical ascites
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Cirrhosis Child-Pugh class A or B (Child-Pugh score of ≤ 9)
* Hemoglobin ≥ 100 g/L
* ANC ≥ 1,200/mm³
* Platelet count ≥ 50,000/mm³
* ALT and AST ≤ 7 times upper limit of normal (ULN)
* AP ≤ 10 times ULN
* Bilirubin ≤ 50 μmol/L
* INR ≤ 2
* Creatinine clearance ≥ 50 mL/min
* Functional left kidney (scintigraphy mandatory for phase I, phase II only if indicated)
* Lipase ≤ 2 times ULN (phase I only)
* Able to tolerate proton-pump inhibitors or H2 antagonists during radiation therapy
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 4 months after completion of study therapy
* No prior malignancy allowed, except for the following:
* Adequately treated cervical carcinoma in situ
* Adequately treated localized nonmelanoma skin cancer
* Any other malignancy from which patient has been disease-free for 5 years
* No presence of medically uncontrolled encephalopathy
* No myocardial infarction within the past 6 months
* No esophageal varices ≥ grade 3, with red signs, or bleeding within the past 3 months
* No symptoms of colitis, enteritis, esophagitis, fistula, gastritis, ileus, necrosis, perforation, stricture, or ulcer
* No severe anorexia, constipation, dehydration, diarrhea, or vomiting
* No serious underlying medical condition that, in the opinion in the investigator, would preclude study participation (e.g., active autoimmune disease or uncontrolled diabetes)
* Portal vein thrombosis allowed
* No psychiatric disorder precluding understanding of information on study related topics or giving informed consent
* No nutritional intake \< 1500 calories per day (corrected)
* No weight loss ≥ 15 % within the past 3 months
PRIOR CONCURRENT THERAPY:
* At least 8 weeks since prior transarterial chemoembolization (TACE), radiofrequency ablation, or radiotherapy (RT) unless progressive disease was documented after this therapy
* At least 21 days since prior and no other concurrent treatment with experimental drugs
* At least 21 days since prior and no other concurrent treatment on another clinical trial
* At least 21 days since prior and no other concurrent anticancer therapy
* No prior RT to the abdomen or caudal chest
* Prior RT to pelvis allowed
* Prior RT to chest must be above D5 vertebra
* Portal vein embolization ligation or pre-RT TACE allowed
* No concurrent treatment with steroids or non-steroidal anti-inflammatory drugs during RT (proton-pump inhibitor allowed)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00777894
Study Brief:
Protocol Section:
NCT00777894