Comparing Re-TACE Versus SABR for Post-prior-TACE Incompletely Regressed HCC: a Randomized Controlled Trial (TASABR)
NCT02921139 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2021-08-30
Summary
Till now, trans-arterial chemoembolization (TACE) is still one of the common modalities in treating hepatocellular carcinoma patients with unresectable intermediate stage. However, residual viable HCC after TACE is not uncommon, leading to a poor overall survival after TACE alone. Recently, stereotactic ablative radiotherapy (SABR) has been reported to be potentially useful for curatively managing early-stage HCC in retrospective studies. Thus, conducting a randomized clinical trial to test the role of SABR in eradicating post-TACE residual tumors is therefore encouraged. The present phase-III trial intended to compare clinical outcomes between TACE + SABR and TACE + re-TACE for HCC patients with post-prior-TACE residual tumors.
Conditions
- Hepatocellular Carcinoma(HCC)
Interventions
- RADIATION
-
Stereotactic ablative radiotherapy (SABR)
Patients with HCC after incomplete TACE are randomized to stereotactic ablative radiotherapy (SABR). SABR will be delivered in 5 fractions.The preferred inter-fraction time interval is 48 hours. The entire treatment with 10 days is preferred.
- PROCEDURE
-
Re-Transcatheter arterial chemoembolization (re-TACE)
Patients with HCC after incomplete TACE are randomized to further re-TACE.
Sponsors & Collaborators
-
Buddhist Tzu Chi General Hospital
collaborator OTHER -
Hualien Tzu Chi General Hospital
collaborator OTHER -
Dalin Tzu Chi General Hospital
lead OTHER
Principal Investigators
-
Shih-Kai Hung, PhD · Chief of Department of Radiation Oncology and Cancer Center, Dalin Tzu Chi Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-11-30
- Primary Completion
- 2022-11-30
- Completion
- 2022-11-30
Countries
- Taiwan
Study Locations
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