The purpose of this clinical study is to determine the maximum tolerated dose (MTD) of 3-dimensional conformal radiation therapy (3-DCRT)/intensity modulated radiation therapy (IMRT) for locally advanced hepatocellular carcinoma (HCC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The starting radiation doses were the total tumor doses of 46 Gy in 2 Gy per fractions for arm I . Escalation was achieved by increasing the tumor dose of each cohort in increments of 4.0 Gy. Subsequent cohorts received higher doses up to a chosen maximum of 62 Gy for arm I.
The starting radiation doses were the total tumor doses of 40 Gy in 2 Gy per fractions for arm II. Escalation was achieved by increasing the tumor dose of each cohort in increments of 4.0 Gy. Subsequent cohorts received higher doses up to a chosen maximum of 52 Gy for arm II.
Toxicity was graded using the CTCAE 3.0. Dose-limiting toxicity was defined as acute ≥ grade 3 hepatic or gastrointestinal toxicity, or any grade 5 treatment-related adverse event, or late complication of radiation-induced liver disease.
Time frame: 4 months
1,2 and 3 years survival
Time frame: 4 years
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