Hepatocellular Carcinoma
Conditions
Keywords
hepatocellular carcinoma, CyberKnife, stereotactic body radiation therapy, Child-Pugh B classification, Child-Pugh C classification
Brief summary
The aim of our research is to evaluate the curative effect and safety of CyberKnife stereotactic body radiation therapy in treating small hepatocellular carcinoma (HCC) patients with decompensated cirrhosis.
Interventions
RADIATIONCyberknife stereotactic body radiation therapy
A total dose of 45-54 Gy in 5-10 fractions was given according to the location of lesions for small HCC patients with decompensated cirrhosis.
Sponsors
Beijing 302 Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Primary HCC diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology * Unfeasible or refusing to undergo other treatments; * Residual normal liver volume ≥700 cc; * With decompensated cirrhosis (Child-Pugh B or C classification); * Without portal vein tumor thrombus; * Eastern Cooperative Oncology Group (ECOG) score 0-1; * Distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm； * Rejecting other therapies such as resection, liver transplantation, etc. * Platelet count≥50 × 109/L, white blood count≥1.5 × 109/L; * Patients infected with hepatitis B virus who are treated with adefovir or entecavir; patients infected with hepatitis C virus whose HCV DNA are negative.
Exclusion criteria
* With Tumor thrombus； * With extrahepatic metastasis; * With lymph node involvement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival time | From date of randomization until the date of death from any cause, assessed up to 36 months | OS is calculated starting from the date of SBRT to the date of the final follow-up or demise of the patients. |
| Progression-free survival time | From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 36 months | PFS is estimated starting from the date of SBRT to the date of disease progression or patient death. |
| Local control time | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months | LC is defined starting from the date of SBRT to the date of treated-lesion progression or patient death. |
Secondary
| Measure | Time frame |
|---|---|
| Radiation-induced liver injury rates | From the date of radiotherapy completion until the 4 months after therapy,up to 6 months. |
| Adverse reaction | From the date of radiotherapy completion until the 4 months after therapy,up to 6 months. |
Countries
China
Contacts
Primary ContactJing Sun
Backup ContactXuezhang Duan
Outcome results
None listed