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| ID | Type | Description | Link |
|---|---|---|---|
| KCT0000454 | Registry Identifier | Clinical Research information Service | |
| KROG 12-02 | Registry Identifier | Korean Radiation Ocology Group | |
| K-1205-001-005 | Other Identifier | Korea Institute of Radiological & Medical Science IRB |
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| Name | Class |
|---|---|
| Dongnam Institute of Radiological & Medical Sciences | OTHER |
| Soonchunhyang University Hospital | OTHER |
| Inje University | OTHER |
| Inha University Hospital |
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The standard treatment for hepatocellular carcinoma (HCC) is surgery, such as, by hepatic resection or liver transplantation, but less than 20% of HCC patients are suitable for surgery. In the remaining patients with inoperable and advanced HCC, trans-arterial chemo-embolization (TACE) has been widely used but TACE alone rarely produces complete response and commonly develops recurrence. Recently several small studies reported high tumor response and local control rate after stereotactic ablative radiotherapy (SABR) alone or with TACE for inoperable HCC. This study will evaluate SABR effect with 60 Gy in 3 fractionations for HCC with size of ≤ 5 cm and 3 cm apart from gastrointestinal tract.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic ablative radiotherapy | Experimental | Stereotactic ablative radiotherapy for unresectable hepatocellular carcinoma with size ≤ 5 cm and 3cm apart from gastrointestinal tract after incomplete trans-arterial chemo-embolization |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic ablative radiotherapy | Radiation | The HCC patients with size ≤5 cm and 3 cm apart from gastrointestinal tract will be included in this study. Total stereotactic ablative radiotherapy (SABR) doses will be 60 Gy in 3 fractionations. Patients receive 3 fractionations separated by >48 hours. At least 700 ml of normal liver (entire liver minus cumulative GTV) should not receive a total dose of > 17 Gy in three fractions. If volume of normal liver does not exceed 700 ml, at least 70% of normal liver should not receive a total dose of > 17 Gy. Dose of esophagus, stomach and intestine do not exceed 30 Gy. |
| Measure | Description | Time Frame |
|---|---|---|
| Local control rate | From the date of SABR to the date of local failure or last follow-up | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | From the date of SABR to the date of death or last follow-up | up to 2 years |
| Progression free survival rate | From the date of SABR to the date of first failure or last follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mi-Sook Kim, MD, PhD | Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Haeundae Paik Hospital | Busan | 612-896 | South Korea | |||
| Dongnam Institute of Radiological & Medical Sciences |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| OTHER |
| Incheon St.Mary's Hospital | OTHER |
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|
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| up to 2 years |
| Intrahepatic recurrence free survival rate | From the date of SABR to the date of Intrahepatic recurrence or last follow-up | up to 2 years |
| Treatment related toxicity | Adverse events using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0; Classic radiation induced liver disease; Non-classic Classic radiation induced liver disease; Worsening of Child-Turcotte-Pugh score; Worsening of MELD score | up to 1 year |
| Busan |
| South Korea |
| Soon Chun Hyang University Hospital Cheonan | Cheonan | South Korea |
| Catholic University Incheon St. Mary's Hospital | Incheon | South Korea |
| Inha University Hospital | Incheon | South Korea |
| Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences | Seoul | 139-706 | South Korea |
| Soon Chun Hyang University Hospital Seoul | Seoul | South Korea |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |