Clinical trial NCT03295500: On the Cyberknife Dose Fraction of Liver Cancer Treatment
Official title: On the Cyberknife Dose Fraction of Liver Cancer Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CyberKnife Radiosurgery
Keywords: CyberKnife
hepatocellular
dose fraction
ICG R15
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 657
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators aim to the hepatocellular participants who receive the radiotherapy through different dose fraction by cyberknife.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Local control rate
timeFrame: From date of the participants completing the therapy until the date of first documented progression, assessed up to 36 months.
measure: Overall survival rate
timeFrame: From date of the participants diagnosed until the date of death from any cause, assessed up to 36 months.
Secondary outcomes:
measure: RILD rate
timeFrame: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.
measure: Child-Pugh score
timeFrame: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.
measure: the value of ICG R15
timeFrame: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: CyberKnife
state: Beijing
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.