Radiation Dose Escalation Study for Advanced Liver Cancer

Study Overview
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Brief Summary
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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).

Official Title
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Phase I Trial of Radiation Dose Escalation for Locally Advanced Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Radiation: 3DCRT/IMRT
* Radiation: 3DCRT/IMRT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: arm 1<br>Arm I: tumor diameter more than 5 cm and less than 10 cm. | Radiation: 3DCRT/IMRT<br>* 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.<br>|
| Other: arm 2<br>Arm II: tumor diameter no less than 10 cm. | Radiation: 3DCRT/IMRT<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1,2 and 3 years survival |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma, radiation therapy, 3-dimensional conformal radiation therapy (3-DCRT), intensity modulated radiation therapy (IMRT), active breathing control