CyberKnife RadiosurgeryNCT03295500

On the Cyberknife Dose Fraction of Liver Cancer Treatment

An observational study of CyberKnife Radiosurgery, run by Beijing 302 Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 30 to 80 yearsHealthy volunteers can take part
Conditions the study is for: CyberKnife Radiosurgery
What is being tested?: Dose fraction forms
Type of treatment: Surgery or procedure
How many people: 657 participants
Where: 1 siteChina
Study dates: 1 Nov 2017to 24 Sep 2021
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

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

Who may be able to join

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

Show all 11Show fewer

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.

Who cannot join

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

Show all 9Show fewer

Intractable ascites
The position of tumor is nearby esophagus, stomach or intestine
The normal liver volume less than 700 cm3

Trial locations and contacts

1 site in 1 country.

China1 site

CyberKnife
Beijing, Beijing Municipality, 100039

Other trials in China

About this study

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.

Conditions: CyberKnife Radiosurgery
Being tested: Dose fraction forms
Keywords: CyberKnife, hepatocellular, dose fraction, ICG R15

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dose fraction formsRadiation
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.

Study groups in NCT03295500
Study group	Role	What they receive
Experimental Group One		In this group ,the participants receive the dose fraction of 49Gy/7f (BED 83.3Gy) by cyberknife. Receives: Radiation: Dose fraction forms
Experimental Group Two		In this group ,the participants receive the dose fraction of 54Gy/6f(BED 102.6Gy) by cyberknife. Receives: Radiation: Dose fraction forms
Control Group		In this group ,the participants receive the dose fraction of 55Gy/5f(115.5Gy) by cyberknife. Receives: Radiation: Dose fraction forms

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

RILD rate
the rate of radiotherapy induced liver disease
Measured: 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.
Measured: 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.
Measured: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201724 Sep 2021

First posted28 Sep 2017
Study start1 Nov 2017
Primary completion10 Sep 2021
Study completion24 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for CyberKnife RadiosurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 657 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03295500
Sponsor's protocol ID: duanxuezhang
Status last verified: Sep 2021
First submitted: 16 Sep 2017
Last updated: 20 Oct 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Stenmark MH, Cao Y, Wang H, Jackson A, Ben-Josef E, Ten Haken RK, Lawrence TS, Feng M. Estimating functional liver reserve following hepatic irradiation: adaptive normal tissue response models. Radiother Oncol. 2014 Jun;111(3):418-23. doi: 10.1016/j.radonc.2014.04.007. Epub 2014 May 8.
PubMed 24813090
Dewas S, Bibault JE, Mirabel X, Fumagalli I, Kramar A, Jarraya H, Lacornerie T, Dewas-Vautravers C, Lartigau E. Prognostic factors affecting local control of hepatic tumors treated by Stereotactic Body Radiation Therapy. Radiat Oncol. 2012 Oct 10;7:166. doi: 10.1186/1748-717X-7-166.
PubMed 23050794
Goodman BD, Mannina EM, Althouse SK, Maluccio MA, Cardenes HR. Long-term safety and efficacy of stereotactic body radiation therapy for hepatic oligometastases. Pract Radiat Oncol. 2016 Mar-Apr;6(2):86-95. doi: 10.1016/j.prro.2015.10.011. Epub 2015 Oct 23.
PubMed 26725957
Liang P, Huang C, Liang SX, Li YF, Huang SX, Lian ZP, Liu JM, Tang Y, Lu HJ. Effect of CyberKnife stereotactic body radiation therapy for hepatocellular carcinoma on hepatic toxicity. Onco Targets Ther. 2016 Nov 18;9:7169-7175. doi: 10.2147/OTT.S112290. eCollection 2016.
PubMed 27920555
Su TS, Lu HZ, Cheng T, Zhou Y, Huang Y, Gao YC, Tang MY, Jiang HY, Lian ZP, Hou EC, Liang P. Long-term survival analysis in combined transarterial embolization and stereotactic body radiation therapy versus stereotactic body radiation monotherapy for unresectable hepatocellular carcinoma >5 cm. BMC Cancer. 2016 Nov 3;16(1):834. doi: 10.1186/s12885-016-2894-9.
PubMed 27809890
Que J, Kuo HT, Lin LC, Lin KL, Lin CH, Lin YW, Yang CC. Clinical outcomes and prognostic factors of cyberknife stereotactic body radiation therapy for unresectable hepatocellular carcinoma. BMC Cancer. 2016 Jul 12;16:451. doi: 10.1186/s12885-016-2512-x.
PubMed 27405814
Schoenberg M, Khandoga A, Stintzing S, Trumm C, Schiergens TS, Angele M, Op den Winkel M, Werner J, Muacevic A, Rentsch M. CyberKnife Radiosurgery - Value as an Adjunct to Surgical Treatment of HCC? Cureus. 2016 Apr 28;8(4):e591. doi: 10.7759/cureus.591.
PubMed 27284498
Su TS, Liang P, Lu HZ, Liang J, Gao YC, Zhou Y, Huang Y, Tang MY, Liang JN. Stereotactic body radiation therapy for small primary or recurrent hepatocellular carcinoma in 132 Chinese patients. J Surg Oncol. 2016 Feb;113(2):181-7. doi: 10.1002/jso.24128. Epub 2015 Dec 14.
PubMed 26799260
Lo CH, Huang WY, Lin KT, Lin MJ, Lin TP, Jen YM. Repeated stereotactic ablative radiotherapy using CyberKnife for patients with hepatocellular carcinoma. J Gastroenterol Hepatol. 2014 Nov;29(11):1919-25. doi: 10.1111/jgh.12659.
PubMed 25041220
Que JY, Lin LC, Lin KL, Lin CH, Lin YW, Yang CC. The efficacy of stereotactic body radiation therapy on huge hepatocellular carcinoma unsuitable for other local modalities. Radiat Oncol. 2014 May 28;9:120. doi: 10.1186/1748-717X-9-120.
PubMed 24885086
Lo CH, Huang WY, Lee MS, Lin KT, Lin TP, Chang PY, Fan CY, Jen YM. Stereotactic ablative radiotherapy for unresectable hepatocellular carcinoma patients who failed or were unsuitable for transarterial chemoembolization. Eur J Gastroenterol Hepatol. 2014 Mar;26(3):345-52. doi: 10.1097/MEG.0000000000000032.
PubMed 24384685
Bibault JE, Dewas S, Vautravers-Dewas C, Hollebecque A, Jarraya H, Lacornerie T, Lartigau E, Mirabel X. Stereotactic body radiation therapy for hepatocellular carcinoma: prognostic factors of local control, overall survival, and toxicity. PLoS One. 2013 Oct 11;8(10):e77472. doi: 10.1371/journal.pone.0077472. eCollection 2013.
PubMed 24147002
Yoon HI, Koom WS, Lee IJ, Jeong K, Chung Y, Kim JK, Lee KS, Han KH, Seong J. The significance of ICG-R15 in predicting hepatic toxicity in patients receiving radiotherapy for hepatocellular carcinoma. Liver Int. 2012 Aug;32(7):1165-71. doi: 10.1111/j.1478-3231.2012.02784.x. Epub 2012 Mar 21.
PubMed 22435801
Sun J, Zhang A, Li W, Wang Q, Li D, Zhang D, Duan X. Biologically effective dose (BED) escalation of stereotactic body radiotherapy (SBRT) for hepatocellular carcinoma patients (</=5 cm) with CyberKnife: protocol of study. Radiat Oncol. 2020 Jan 28;15(1):20. doi: 10.1186/s13014-020-1471-1.
PubMed 31992327

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: On the Cyberknife Dose Fraction of Liver Cancer Treatment
ClinicalTrials.gov ID: NCT03295500
Acronym / sponsor ID: duanxuezhang
Conditions: CyberKnife Radiosurgery
Keywords: CyberKnife, hepatocellular, dose fraction, ICG R15
Study type: Observational
Recruitment status: Completed
Enrolment: 657 participants (actual)
Lead sponsor: Beijing 302 HospitalUniversity, hospital or other
Study start: 1 Nov 2017 (actual)
Primary completion: 10 Sep 2021 (actual)
Study completion: 24 Sep 2021 (actual)
First posted: 28 Sep 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Experimental Group One	–	Radiation: Dose fraction formsIn this group ,the participants receive the dose fraction of 49Gy/7f (BED 83.3Gy) by cyberknife.
Experimental Group Two	–	Radiation: Dose fraction formsIn this group ,the participants receive the dose fraction of 54Gy/6f(BED 102.6Gy) by cyberknife.
Control Group	–	Radiation: Dose fraction formsIn this group ,the participants receive the dose fraction of 55Gy/5f(115.5Gy) by cyberknife.

Who may qualify

Ages: 30 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: The investigators aim to the hepatocellular participants who receive the radiotherapy through different dose fraction by cyberknife.

Key inclusion criteria (11 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dose fraction formsThe 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.	Radiation	Control Group, Experimental Group One, Experimental Group Two

Primary outcome

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.
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.

3 secondary outcomes

RILD rate
Time frame: 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.
the value of ICG R15
Time frame: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
Background: PubMed 24813090Stenmark MH, Cao Y, Wang H, Jackson A, Ben-Josef E, Ten Haken RK, Lawrence TS, Feng M. Estimating functional liver reserve following hepatic irradiation: adaptive normal tissue response models. Radiother Oncol. 2014 Jun;111(3):418-23. doi: 10.1016/j.radonc.2014.04.007. Epub 2014 May 8.
Results publication: PubMed 23050794Dewas S, Bibault JE, Mirabel X, Fumagalli I, Kramar A, Jarraya H, Lacornerie T, Dewas-Vautravers C, Lartigau E. Prognostic factors affecting local control of hepatic tumors treated by Stereotactic Body Radiation Therapy. Radiat Oncol. 2012 Oct 10;7:166. doi: 10.1186/1748-717X-7-166.
Results publication: PubMed 26725957Goodman BD, Mannina EM, Althouse SK, Maluccio MA, Cardenes HR. Long-term safety and efficacy of stereotactic body radiation therapy for hepatic oligometastases. Pract Radiat Oncol. 2016 Mar-Apr;6(2):86-95. doi: 10.1016/j.prro.2015.10.011. Epub 2015 Oct 23.
Results publication: PubMed 27920555Liang P, Huang C, Liang SX, Li YF, Huang SX, Lian ZP, Liu JM, Tang Y, Lu HJ. Effect of CyberKnife stereotactic body radiation therapy for hepatocellular carcinoma on hepatic toxicity. Onco Targets Ther. 2016 Nov 18;9:7169-7175. doi: 10.2147/OTT.S112290. eCollection 2016.
Results publication: PubMed 27809890Su TS, Lu HZ, Cheng T, Zhou Y, Huang Y, Gao YC, Tang MY, Jiang HY, Lian ZP, Hou EC, Liang P. Long-term survival analysis in combined transarterial embolization and stereotactic body radiation therapy versus stereotactic body radiation monotherapy for unresectable hepatocellular carcinoma >5 cm. BMC Cancer. 2016 Nov 3;16(1):834. doi: 10.1186/s12885-016-2894-9.
Results publication: PubMed 27405814Que J, Kuo HT, Lin LC, Lin KL, Lin CH, Lin YW, Yang CC. Clinical outcomes and prognostic factors of cyberknife stereotactic body radiation therapy for unresectable hepatocellular carcinoma. BMC Cancer. 2016 Jul 12;16:451. doi: 10.1186/s12885-016-2512-x.
Results publication: PubMed 27284498Schoenberg M, Khandoga A, Stintzing S, Trumm C, Schiergens TS, Angele M, Op den Winkel M, Werner J, Muacevic A, Rentsch M. CyberKnife Radiosurgery - Value as an Adjunct to Surgical Treatment of HCC? Cureus. 2016 Apr 28;8(4):e591. doi: 10.7759/cureus.591.
Results publication: PubMed 26799260Su TS, Liang P, Lu HZ, Liang J, Gao YC, Zhou Y, Huang Y, Tang MY, Liang JN. Stereotactic body radiation therapy for small primary or recurrent hepatocellular carcinoma in 132 Chinese patients. J Surg Oncol. 2016 Feb;113(2):181-7. doi: 10.1002/jso.24128. Epub 2015 Dec 14.
Results publication: PubMed 25041220Lo CH, Huang WY, Lin KT, Lin MJ, Lin TP, Jen YM. Repeated stereotactic ablative radiotherapy using CyberKnife for patients with hepatocellular carcinoma. J Gastroenterol Hepatol. 2014 Nov;29(11):1919-25. doi: 10.1111/jgh.12659.
Results publication: PubMed 24885086Que JY, Lin LC, Lin KL, Lin CH, Lin YW, Yang CC. The efficacy of stereotactic body radiation therapy on huge hepatocellular carcinoma unsuitable for other local modalities. Radiat Oncol. 2014 May 28;9:120. doi: 10.1186/1748-717X-9-120.
Results publication: PubMed 24384685Lo CH, Huang WY, Lee MS, Lin KT, Lin TP, Chang PY, Fan CY, Jen YM. Stereotactic ablative radiotherapy for unresectable hepatocellular carcinoma patients who failed or were unsuitable for transarterial chemoembolization. Eur J Gastroenterol Hepatol. 2014 Mar;26(3):345-52. doi: 10.1097/MEG.0000000000000032.
Results publication: PubMed 24147002Bibault JE, Dewas S, Vautravers-Dewas C, Hollebecque A, Jarraya H, Lacornerie T, Lartigau E, Mirabel X. Stereotactic body radiation therapy for hepatocellular carcinoma: prognostic factors of local control, overall survival, and toxicity. PLoS One. 2013 Oct 11;8(10):e77472. doi: 10.1371/journal.pone.0077472. eCollection 2013.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of CyberKnife Radiosurgery, run by Beijing 302 Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03295500, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.