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| ID | Type | Description | Link |
|---|---|---|---|
| KCT0000454 | Registry Identifier | Clinical Research Information Service | |
| K-1201-001-004 | Other Identifier | [Registry ID: Clinical Research information Service |
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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 body radiotherapy (SBRT) alone or with TACE for inoperable HCC. A single institution phase II trial with SBRT for inoperable HCC after incomplete TACE at Korea Cancer Center Hospital showed promising results: the overall response rate of 73% and 2-year local control rate of 95%. They reported severe gastrointestinal toxicity of 11% because there was no normal tissue constraint for gastrointestinal tract and dosage to gastrointestinal tract was restricted to the lowest levels possible. In addition, they found that the presence of gastroduodenal ulcer before SBRT was significantly influenced on severe gastrointestinal toxicity. Based on this study, we will conduct a multicenter phase II trial on maintenance of treatment results and reduction of severe treatment related toxicity below 5%. To achieve this, we strictly apply normal tissue constraints. Secondly, we will do Esophagogastroduodenoscopy (EGD) before SBRT to evaluate gastroduodenal ulcer. After then, we will apply the normal tissue constraint of gastrointestinal tract according to gastroduodenal ulcer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic body radiotherapy | Experimental | Stereotactic body radiotherapy for unresectable hepatocellular carcinoma after incomplete trans-arterial chemo-embolization |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic body radiotherapy | Radiation | Total stereotactic Body radiotherapy (SBRT) 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. In patients without gastroduodenal ulcer on Esophagogastroduodenoscopy (EGD) before SBRT, D2ml of gastrointestinal tract should not exceed 35 Gy. In patients with gastroduodenal ulcer on EGD before SBRT, D2ml of gastrointestinal tract should exceed 28 Gy. (D2ml: minimum dose to 2 ml of gastrointestinal tract) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment related toxicity-free survival | From the date of SBRT to the date of treatment related toxicity or last follow-up; Treatment related toxicity will be evaluated by the following criteria.
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | From the date of SBRT to the date of death or last follow-up | 2 years |
| Progression free survival | From the date of SBRT 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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|
|
| 2 years |
| Intrahepatic recurrence free survival | From the date of SBRT to the date of Intrahepatic recurrence or last follow-up | 2 years |
| Patterns of failure | Patterns of failure (local, intrahepatic, or systemic) | 2 years |
| Systemic failure free survival | From the date of SBRT to the date of systemin failure or last follow-up | 2 years |
| Local control rate | From the date of SBRT to the date of local failure or last follow-up | 2 years |
| 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 |