NCT03609151

Stereotactic Body Radiotherapy and Surgery for Early-stage Hepatocellular Carcinoma

Effects of Stereotactic Body Radiotherapy and Surgery for Early-stage Hepatocellular Carcinoma: a Prospective,Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The prognosis of small liver cancer (≤5 cm) with stereotactic body radiotherapy (SBRT) is encouraging, the 1-year local control rate has been reported to be 95-100%, 3-year local control rate about 91%, and 3-year overall survival rate around 70%. So far, there is no randomized controlled study comparing SBRT and surgical treatment for early-stage liver cancer. It is hoped that this study will further compare the efficacy of SBRT and surgery for early stage liver cancer.

Detailed description

Early stage liver cancer, according to Milan criteria, are chose for this study. The patients are divided into two groups randomly. Patients in group A receive laparoscopic hepatectomy, group B patients receive SBRT.The 3-year progression free survival, 3-year local recurrence free survival, 3- year overall survival and other endpoints events were recorded and analyzed, to assess whether SBRT is non-inferior to surgery.

Conditions

• Hepatocellular Carcinoma
• Hepatectomy
• Stereotactic Body Radiotherapy

Interventions

Type	Name	Description
PROCEDURE	laparoscopic hepatectomy (surgery)	Patients receive laparoscopic hepatectomy.
RADIATION	stereotactic body radiotherapy	Patients receive stereotactic body radiotherapy(SBRT)

Timeline

• Start date: 2018-06-30
• Primary completion: 2021-05-31
• Completion: 2021-05-31
• First posted: 2018-08-01
• Last updated: 2018-08-01

Locations

1 site across 1 country: China