Clinical trial · Observational
On the Cyberknife Dose Fraction of Liver Cancer Treatment
NCT03295500CI-TRIAL-00054568completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CyberKnife Radiosurgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dose fraction forms | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Experimental Group One
- description
- In this group ,the participants receive the dose fraction of 49Gy/7f (BED 83.3Gy) by cyberknife.
- interventionNames
- Radiation: Dose fraction forms
- label
- Experimental Group Two
- description
- In this group ,the participants receive the dose fraction of 54Gy/6f(BED 102.6Gy) by cyberknife.
- interventionNames
- Radiation: Dose fraction forms
- label
- Control Group
- description
- In this group ,the participants receive the dose fraction of 55Gy/5f(115.5Gy) by cyberknife.
- interventionNames
- Radiation: Dose fraction forms
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (14)
- BACKGROUNDStenmark 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. PMID 24813090
- RESULTDewas 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. PMID 23050794
- RESULTGoodman 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. PMID 26725957
- RESULTLiang 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. PMID 27920555
- RESULTSu 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. PMID 27809890
- RESULTQue 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. PMID 27405814