Radiation Dose Escalation Study for Advanced Liver Cancer
Phase 1
Completed
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Radiation: 3DCRT/IMRT
- Registration Number
- NCT00848094
- Lead Sponsor
- Fudan University
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description arm 1 3DCRT/IMRT Arm I: tumor diameter more than 5 cm and less than 10 cm. arm 2 3DCRT/IMRT Arm II: tumor diameter no less than 10 cm.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1,2 and 3 years survival 4 years