On the Cyberknife Dose Fraction of Liver Cancer Treatment

Beijing 302 Hospital

Status: Completed

Conditions: CyberKnife Radiosurgery

Treatments: Radiation: Dose fraction forms

Study type: Observational

Funder types: Other

Identifiers

NCT03295500

duanxuezhang

Details and patient eligibility

About

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.

Enrollment: 657 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

657 participants in 3 patient groups

Experimental Group One

Description:

In this group ,the participants receive the dose fraction of 49Gy/7f (BED 83.3Gy) by cyberknife.

Treatment:

Radiation: Dose fraction forms

Experimental Group Two

Description:

In this group ,the participants receive the dose fraction of 54Gy/6f(BED 102.6Gy) by cyberknife.

Treatment:

Radiation: Dose fraction forms

Control Group

Description:

In this group ,the participants receive the dose fraction of 55Gy/5f(115.5Gy) by cyberknife.

Treatment:

Radiation: Dose fraction forms