Comparing stereotactic ablative radiotherapy (SABR) versus re-trans-catheter arterial chemoembolization (re-TACE) for hepatocellular carcinoma patients who had incomplete response after initial TACE (TASABR): a randomized controlled trial
Abstract Background Hepatocellular carcinoma (HCC) accounts for 75–85% of primary liver cancers and is prevalent in the Asia-Pacific region. Till now, trans-arterial chemoembolization (TACE) is still one of common modalities in managing unresectable intermediate-stage HCC. However, post-TACE residua...
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| Format: | Article |
| Language: | English |
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BMC
2019-03-01
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| Series: | BMC Cancer |
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| Online Access: | http://link.springer.com/article/10.1186/s12885-019-5461-3 |
| _version_ | 1818526995574685696 |
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| author | Liang-Cheng Chen Wen-Yen Chiou Hon-Yi Lin Moon-Sing Lee Yuan-Chen Lo Li-Wen Huang Chun-Ming Chang Tsung-Hsing Hung Chih-Wen Lin Kuo-Chih Tseng Dai-Wei Liu Feng-Chun Hsu Shih-Kai Hung |
| author_facet | Liang-Cheng Chen Wen-Yen Chiou Hon-Yi Lin Moon-Sing Lee Yuan-Chen Lo Li-Wen Huang Chun-Ming Chang Tsung-Hsing Hung Chih-Wen Lin Kuo-Chih Tseng Dai-Wei Liu Feng-Chun Hsu Shih-Kai Hung |
| author_sort | Liang-Cheng Chen |
| collection | DOAJ |
| description | Abstract Background Hepatocellular carcinoma (HCC) accounts for 75–85% of primary liver cancers and is prevalent in the Asia-Pacific region. Till now, trans-arterial chemoembolization (TACE) is still one of common modalities in managing unresectable intermediate-stage HCC. However, post-TACE residual viable HCC is not uncommon, resulting in unsatisfied overall survival after TACE alone. Recently, stereotactic ablative radiotherapy (SABR) has been suggested to manage HCC curatively. However, evidence from phase-III trials is largely lacking. Hence, the present phase III randomized trial is designed to compare clinical outcomes between SABR and re-TACE for unresectable HCC patients who had incomplete response after initial TACE. Methods The present study is an open-label, parallel, randomized controlled trial. A total of 120 patients will be included into two study groups, i.e., SABR and re-TACE, with a 1:1 allocation rate. A 3-year allocating period is planned. Patients with incomplete response after initial TACE will be enrolled and randomized. The primary endpoint is 1-year freedom-form-local-progression rate. Secondary endpoints are disease-progression-free survival, overall survival, local control, response rate, toxicity, and duration of response of the treated tumor. Discussion SABR has been reported as an effective modality in managing intermediate-stage HCC patients, but evidence from phase-III randomized trials is largely lacking. As a result, conducting randomized trials to demarcate the role of SABR in these patients is warranted, especially in the Asia-Pacific region, where HBV- and HCV-related HCCs are prevalent. Trial registration Before enrolling participants, the present study was registered prospectively on ClinicalTrials.gov (trial identifier, NCT02921139) on Sep. 29, 2016. This study is ongoing. |
| first_indexed | 2024-12-11T06:30:25Z |
| format | Article |
| id | doaj.art-647b98f689c147549697a66fd373447c |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-12-11T06:30:25Z |
| publishDate | 2019-03-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-647b98f689c147549697a66fd373447c2022-12-22T01:17:32ZengBMCBMC Cancer1471-24072019-03-0119111110.1186/s12885-019-5461-3Comparing stereotactic ablative radiotherapy (SABR) versus re-trans-catheter arterial chemoembolization (re-TACE) for hepatocellular carcinoma patients who had incomplete response after initial TACE (TASABR): a randomized controlled trialLiang-Cheng Chen0Wen-Yen Chiou1Hon-Yi Lin2Moon-Sing Lee3Yuan-Chen Lo4Li-Wen Huang5Chun-Ming Chang6Tsung-Hsing Hung7Chih-Wen Lin8Kuo-Chih Tseng9Dai-Wei Liu10Feng-Chun Hsu11Shih-Kai Hung12Department of Radiation Oncology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationDepartment of Radiation Oncology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationDepartment of Radiation Oncology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationDepartment of Radiation Oncology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationDepartment of Radiation Oncology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationDepartment of Radiation Oncology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationDepartment of General Surgery, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationDepartment of Gastroenterology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationDepartment of Radiology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationDepartment of Gastroenterology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationDepartment of Radiation Oncology, Buddhist Tzu Chi General HospitalDepartment of Radiation Oncology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationDepartment of Radiation Oncology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationAbstract Background Hepatocellular carcinoma (HCC) accounts for 75–85% of primary liver cancers and is prevalent in the Asia-Pacific region. Till now, trans-arterial chemoembolization (TACE) is still one of common modalities in managing unresectable intermediate-stage HCC. However, post-TACE residual viable HCC is not uncommon, resulting in unsatisfied overall survival after TACE alone. Recently, stereotactic ablative radiotherapy (SABR) has been suggested to manage HCC curatively. However, evidence from phase-III trials is largely lacking. Hence, the present phase III randomized trial is designed to compare clinical outcomes between SABR and re-TACE for unresectable HCC patients who had incomplete response after initial TACE. Methods The present study is an open-label, parallel, randomized controlled trial. A total of 120 patients will be included into two study groups, i.e., SABR and re-TACE, with a 1:1 allocation rate. A 3-year allocating period is planned. Patients with incomplete response after initial TACE will be enrolled and randomized. The primary endpoint is 1-year freedom-form-local-progression rate. Secondary endpoints are disease-progression-free survival, overall survival, local control, response rate, toxicity, and duration of response of the treated tumor. Discussion SABR has been reported as an effective modality in managing intermediate-stage HCC patients, but evidence from phase-III randomized trials is largely lacking. As a result, conducting randomized trials to demarcate the role of SABR in these patients is warranted, especially in the Asia-Pacific region, where HBV- and HCV-related HCCs are prevalent. Trial registration Before enrolling participants, the present study was registered prospectively on ClinicalTrials.gov (trial identifier, NCT02921139) on Sep. 29, 2016. This study is ongoing.http://link.springer.com/article/10.1186/s12885-019-5461-3Hepatocellular carcinoma (HCC)Trans-arterial chemoembolization (TACE)Stereotactic ablative radiotherapy (SABR)Stereotactic body radiation therapy (SBRT) |
| spellingShingle | Liang-Cheng Chen Wen-Yen Chiou Hon-Yi Lin Moon-Sing Lee Yuan-Chen Lo Li-Wen Huang Chun-Ming Chang Tsung-Hsing Hung Chih-Wen Lin Kuo-Chih Tseng Dai-Wei Liu Feng-Chun Hsu Shih-Kai Hung Comparing stereotactic ablative radiotherapy (SABR) versus re-trans-catheter arterial chemoembolization (re-TACE) for hepatocellular carcinoma patients who had incomplete response after initial TACE (TASABR): a randomized controlled trial BMC Cancer Hepatocellular carcinoma (HCC) Trans-arterial chemoembolization (TACE) Stereotactic ablative radiotherapy (SABR) Stereotactic body radiation therapy (SBRT) |
| title | Comparing stereotactic ablative radiotherapy (SABR) versus re-trans-catheter arterial chemoembolization (re-TACE) for hepatocellular carcinoma patients who had incomplete response after initial TACE (TASABR): a randomized controlled trial |
| title_full | Comparing stereotactic ablative radiotherapy (SABR) versus re-trans-catheter arterial chemoembolization (re-TACE) for hepatocellular carcinoma patients who had incomplete response after initial TACE (TASABR): a randomized controlled trial |
| title_fullStr | Comparing stereotactic ablative radiotherapy (SABR) versus re-trans-catheter arterial chemoembolization (re-TACE) for hepatocellular carcinoma patients who had incomplete response after initial TACE (TASABR): a randomized controlled trial |
| title_full_unstemmed | Comparing stereotactic ablative radiotherapy (SABR) versus re-trans-catheter arterial chemoembolization (re-TACE) for hepatocellular carcinoma patients who had incomplete response after initial TACE (TASABR): a randomized controlled trial |
| title_short | Comparing stereotactic ablative radiotherapy (SABR) versus re-trans-catheter arterial chemoembolization (re-TACE) for hepatocellular carcinoma patients who had incomplete response after initial TACE (TASABR): a randomized controlled trial |
| title_sort | comparing stereotactic ablative radiotherapy sabr versus re trans catheter arterial chemoembolization re tace for hepatocellular carcinoma patients who had incomplete response after initial tace tasabr a randomized controlled trial |
| topic | Hepatocellular carcinoma (HCC) Trans-arterial chemoembolization (TACE) Stereotactic ablative radiotherapy (SABR) Stereotactic body radiation therapy (SBRT) |
| url | http://link.springer.com/article/10.1186/s12885-019-5461-3 |
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