CyberKnife Radiosurgery Clinical Trial
Official title:
On the Cyberknife Dose Fraction of Liver Cancer Treatment
| Verified date | September 2021 |
| Source | Beijing 302 Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 657 |
| Est. completion date | September 24, 2021 |
| Est. primary completion date | September 10, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 30 Years to 80 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| China | CyberKnife | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Beijing 302 Hospital |
China,
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 O — View 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. d — View Citation
Goodman BD, Mannina EM, Althouse SK, Maluccio MA, Cárdenes 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 — View 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. eCollection 2016. — View 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 M — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. E — View 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 unre — View 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 — View Citation
* Note: There are 13 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | From date of the participants completing the therapy until the date of first documented progression, assessed up to 36 months. | |
| Primary | Overall survival rate | 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 | RILD rate | the rate of radiotherapy induced liver disease | From the date of radiotherapy completion until the 4 months after therapy,up to 6 months. | |
| Secondary | 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. | From the date of radiotherapy completion until the 4 months after therapy,up to 6 months. | |
| Secondary | the value of ICG R15 | 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. |