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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Active Comparator | laparoscopic hepatectomy (surgery) |
|
| group B | Experimental | stereotactic body radiotherapy (SBRT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic hepatectomy (surgery) | Procedure | Patients receive laparoscopic hepatectomy. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | The duration (months) between the date of surgery or the first fraction of SBRT until the date of first progression | From the date of surgery or the first fraction of SBRT until the date of first progression (local or distant), assessed up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Local recurrence free survival | The duration (months) between the date of surgery or the first fraction of SBRT until the date of local recurrence | From the date of surgery or the first fraction of SBRT until the date of local recurrence, assessed up to 3 years |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qichun Wei, MD,PhD | Contact | +86 571 87783521 | qichun_wei@zju.edu.cn | |
| Yongjie Shui, MM | Contact | +86 571 87783521 | shui-yongjie@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the second affiliated hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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Parallel Assignment
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| stereotactic body radiotherapy |
| Radiation |
Patients receive stereotactic body radiotherapy(SBRT) |
|
The duration (months) between the date of surgery or the first fraction of SBRT until the date of death. |
| From the date of surgery or the first fraction of SBRT until the date of death, assessed up to 3 years |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D008919 | Investigative Techniques |
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