On the Cyberknife Dose Fraction of Liver Cancer Treatment

October 18, 2021 updated by: Beijing 302 Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

657

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100039
        • CyberKnife

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The investigators aim to the hepatocellular participants who receive the radiotherapy through different dose fraction by cyberknife.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental Group One
In this group ,the participants receive the dose fraction of 49Gy/7f (BED 83.3Gy) by cyberknife.
Radiation: Dose fraction forms
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.
Experimental Group Two
In this group ,the participants receive the dose fraction of 54Gy/6f(BED 102.6Gy) by cyberknife.
Radiation: Dose fraction forms
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.
Control Group
In this group ,the participants receive the dose fraction of 55Gy/5f(115.5Gy) by cyberknife.
Radiation: Dose fraction forms
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of the participants completing the therapy until the date of first documented progression, assessed up to 36 months.
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.
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
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
From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.
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.
From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.
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.
From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing 302 Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

September 10, 2021

Study Completion (Actual)

September 24, 2021

Study Registration Dates

First Submitted

September 16, 2017

First Submitted That Met QC Criteria

September 24, 2017

First Posted (Actual)

September 28, 2017

Study Record Updates

Last Update Posted (Actual)

October 20, 2021

Last Update Submitted That Met QC Criteria

October 18, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • duanxuezhang

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on CyberKnife Radiosurgery

Clinical Trials on Dose fraction forms

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe