Radiation Dose Escalation Study for Advanced Liver Cancer
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 Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of Radiation Dose Escalation for Locally Advanced Hepatocellular Carcinoma|
- 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 ] [ Designated as safety issue: Yes ]
- 1,2 and 3 years survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2005|
|Study Completion Date:||May 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Arm I: tumor diameter more than 5 cm and less than 10 cm.
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.
Arm II: tumor diameter no less than 10 cm.
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.