NCT03609268

Stereotactic Body Radiotherapy and Microwave Ablation for Recurrent Small Hepatocellular Carcinoma

Effects of Stereotactic Body Radiotherapy and Microwave Ablation for Recurrent Small Hepatocellular Carcinoma: a Prospective, Randomized Controlled Study

• 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) who had underwent stereotactic body radiotherapy (SBRT) is encouraging, with the 1-year local control rate has been reported to be 95-100%, 3-year local control rate about 91%, 3-year overall survival rate around 70%. Local ablation therapy has become the standard treatment for recurrent liver cancer after surgery and interventional treatment. The ablation rate of tumors with a diameter of 3.1-5.0 cm reached 90%. The 1, 2, and 3-year survival rates had been reported to be 89%, 74%, and 60%, respectively, which is similar to that of surgical resection. At present, there is no randomized controlled study of SBRT and microwave ablation (MWA) for small liver cancer. It is hoped that this study will further compare the efficacy of SBRT and MWA for recurrent small hepatocellular carcinoma.

Detailed description

Recurrent small hepatocellular carcinoma after surgery or local ablation therapy are chose for this study. The patients are divided into two groups randomly. Patients in group A receive MWA, 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 MWA.

Conditions

• Recurrent Hepatocellular Carcinoma
• Microwave Ablation
• Stereotactic Body Radiotherapy

Interventions

Type	Name	Description
DEVICE	microwave ablation (MWA)	microwave ablation (MWA) for recurrent small liver cancer
RADIATION	stereotactic body radiotherapy (SBRT)	stereotactic body radiotherapy (SBRT) for recurrent small liver cancer

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