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| Name | Class |
|---|---|
| Soonchunhyang University Hospital | OTHER |
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Comparison of Stereotactic Body Radiation Therapy (SBRT) and repeated transarterial chemoembolization (TACE) for Hepatocellular Carcinoma (HCC)as a Local Salvage Treatment after first incomplete TACE
The aim of this study is to evaluate the effect of SBRT after first incomplete TACE.
In HCC patients with incomplete TACE response, repeated TACE did not showed good response. In this case, SBRT could have better results than TACE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT (Stereotatic body radiotherapy) | Experimental | Treatment of SBRT in HCC patients who have incomplete response after first TACE |
|
| TACE (Transarterial chemoembolization) | No Intervention | Treatment of repeated TACE in HCC patients who have incomplete response after first TACE |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT | Radiation | Maximum dose : 60Gray (Gy) Fraction : 2 to 5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local tumor control (efficacy fo SBRT) | To evaluate the effect of SBRT. Local tumor control is defined as the disappearance of any intraarterial enhancement in all target lesions. Local tumor control will be measured on triphasic Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI). Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| progression free-survival | survival from SBRT to recurrence | 2 year |
| overall survival | survival from SBRT to death | 2 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Baek Gyu Jun, M.D | Contact | +82-10-5764-0712 | backyou78@hanmail.net |
| Name | Affiliation | Role |
|---|---|---|
| Gab Jin Cheon, M.D, Ph. D | University of Ulsan College of Medicine, Gangneung Asan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangneung Asan Hospital | Recruiting | Wŏnju | Gangwondo | 25440 | South Korea |
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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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| Radiation induced liver disease (RILD) | Liver toxicities were evaluated using Common Terminology Criteria of Adverse Events (CTCAE). RILD was defined as elevated liver transaminases more than five times the upper normal limit or a worsening of Child-Pugh (CP) score by 2 within 3 months after SBRT. | 1 year |
| 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 |