Radiation Dose Escalation Study for Advanced Liver Cancer
|ClinicalTrials.gov Identifier: NCT00848094|
Recruitment Status : Completed
First Posted : February 20, 2009
Last Update Posted : February 20, 2009
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Radiation: 3DCRT/IMRT||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Radiation Dose Escalation for Locally Advanced Hepatocellular Carcinoma|
|Study Start Date :||April 2005|
|Primary Completion Date :||January 2008|
|Study Completion Date :||May 2008|
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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848094
|Principal Investigator:||Guoliang Jiang, M.D.||Fudan University|