Hepatocellular Carcinoma
Conditions
Keywords
hepatocellular carcinoma, radiation therapy, 3-dimensional conformal radiation therapy (3-DCRT), intensity modulated radiation therapy (IMRT), active breathing control
Brief summary
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).
Interventions
RADIATION3DCRT/IMRT
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.
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed or clinically diagnosed HCC * Surgically unsectable or medically inoperable diseases, or surgery declined by the patient * Solitary intrahepatic lesion with diameter bigger than 5 cm, without extrahepatic and/or distant metastases * Associated with cirrhosis of Child-Pugh A * Karnofsky performance status (KPS) of ≥ 70 * Normal renal function and adequate bone marrow reservation * Tolerate active breathing control (ABC)
Exclusion criteria
* Child-Pugh B or C liver cirrhosis score * Previous radiotherapy to the liver * Indistinct tumor boundary in CT/MRI image
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| 1,2 and 3 years survival | 4 years |
Outcome results
None listed