On the Cyberknife Dose Fraction of Liver Cancer Treatment

Study Overview
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Brief Summary
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The research aims to the primary hepatic carcinoma patients whose diameter of the single tumor is equal or less than 5cm.By supervising the changes of liver function, Child-Pugh score, ICG-R15 value, secondary reaction, incidence rate of RILD during and after the radiotherapy, meanwhile combining the outcome of the progression of disease and the condition of survival quality, the optimum proposal could be obtained and apply to clinic thus make the treatment safe, effective and personalized.

Official Title
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On the Cyberknife Dose Fraction of Liver Cancer Treatment

Conditions
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CyberKnife Radiosurgery

Intervention / Treatment
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* Radiation: Dose fraction forms


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The participants are from 30 to 80 years of age, without gender restriction With the hepatopathy background, the diagnosis of primary hepatic carcinoma is confirmed by image examination and laboratory test(the diagnosis criteria is according to the primary hepatic carcinoma rule of diagnosis and treat in 2007) The max diameter of single tumor ≤5cm Child-Pugh Classification(CPC) A or B ECOG score 0 or 1 Leukocyte is more than 2×109/L and thrombocyte is more than 60×109/L Kidney function is normal Unsuitable or rejecting other therapies such as resection, liver transplantation etc Anticipated lifetime is longer than six months The participants who are voluntary comply with the requirements of research The participants agree to sign the informed consent. Exclusion Criteria: The metastasis occur outside of liver Child-Pugh Classification(CPC) The outline of tumor is not confirmed by image examination With hepatic or any other abdomen radiotherapy history before With severe internal medicine diseases Bone marrow haematopoietic function or kidney function is severe failure Intractable ascites The position of tumor is nearby esophagus, stomach or intestine The normal liver volume less than 700 cm3

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental Group One<br>In this group ,the participants receive the dose fraction of 49Gy/7f (BED 83.3Gy) by cyberknife. | Radiation: Dose fraction forms<br>* The investigators divide the participants randomly into 3 groups by SPSS 19.0.Three groups participants receive the different dose fraction(49Gy/7f,54Gy/6f and 55Gy/5f),which also means different Biologic Equivalent Dose.Through the research,the investigators want to find out the optimum dose fraction method,which makes the treatment safe, effective and personalized.<br>|
| Experimental Group Two<br>In this group ,the participants receive the dose fraction of 54Gy/6f(BED 102.6Gy) by cyberknife. | Radiation: Dose fraction forms<br>* The investigators divide the participants randomly into 3 groups by SPSS 19.0.Three groups participants receive the different dose fraction(49Gy/7f,54Gy/6f and 55Gy/5f),which also means different Biologic Equivalent Dose.Through the research,the investigators want to find out the optimum dose fraction method,which makes the treatment safe, effective and personalized.<br>|
| Control Group<br>In this group ,the participants receive the dose fraction of 55Gy/5f(115.5Gy) by cyberknife. | Radiation: Dose fraction forms<br>* The investigators divide the participants randomly into 3 groups by SPSS 19.0.Three groups participants receive the different dose fraction(49Gy/7f,54Gy/6f and 55Gy/5f),which also means different Biologic Equivalent Dose.Through the research,the investigators want to find out the optimum dose fraction method,which makes the treatment safe, effective and personalized.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control rate | Local control illustrates the time from the tumor appearance to progress (the diameter more than or equal to 1.5 times of original) .The ratio of the number of the local control patients to the whole number of patients is local control rate. | From date of the participants completing the therapy until the date of first documented progression, assessed up to 36 months. | 
| Overall survival rate | Overall survival rate means the ratio of the number of patients who are alive to the whole patients after the treatment. | From date of the participants diagnosed until the date of death from any cause, assessed up to 36 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RILD rate | the rate of radiotherapy induced liver disease | From the date of radiotherapy completion until the 4 months after therapy,up to 6 months. | 
| Child-Pugh score | By testing the liver function,coagulation function and ascites,we could calculate the Child-Pugh score,which reflect the liver function roundly. | From the date of radiotherapy completion until the 4 months after therapy,up to 6 months. | 
| the value of ICG R15 | It means the indocyanine green retention rate at 15 minutes,which reflects the liver reserve. | From the date of radiotherapy completion until the 4 months after therapy,up to 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CyberKnife, hepatocellular, dose fraction, ICG R15