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Completed

NCT Number: NCT03295500

On the Cyberknife Dose Fraction of Liver Cancer Treatment

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.

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Key information

Conditions

CyberKnife Radiosurgery

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CyberKnife

Beijing, Beijing Municipality, 100039, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dose fraction forms

Radiation

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.

Primary outcomes

  1. Local control rate

    Time frame: From date of the participants completing the therapy until the date of first documented progression, assessed up to 36 months.

    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.

  2. Overall survival rate

    Time frame: From date of the participants diagnosed until the date of death from any cause, assessed up to 36 months.

    Overall survival rate means the ratio of the number of patients who are alive to the whole patients after the treatment.

Secondary outcomes

  1. RILD rate

    Time frame: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.

    the rate of radiotherapy induced liver disease

  2. Child-Pugh score

    Time frame: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.

    By testing the liver function,coagulation function and ascites,we could calculate the Child-Pugh score,which reflect the liver function roundly.

  3. the value of ICG R15

    Time frame: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.

    It means the indocyanine green retention rate at 15 minutes,which reflects the liver reserve.

Sponsors and collaborators

Lead sponsor

Beijing 302 Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Sep 28, 2017
Registry last updated
Oct 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.