Transarterial Chemoembolization Compared With Stereotactic Body Radiation Therapy or Stereotactic Ablative Radiation Therapy in Treating Patients With Residual or Recurrent Liver Cancer Undergone Initial Transarterial Chemoembolization
NCT02762266 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2024-03-12
Summary
This randomized phase III trial studies how well transarterial chemoembolization (TACE) works compared to stereotactic body radiation therapy (SBRT) or stereotactic ablative radiation therapy (SABR) in patients with liver cancer that remain after attempts to remove the cancer have been made (residual) or has come back (recurrent). TACE is a minimally invasive, image-guided treatment procedure that uses a catheter to deliver both chemotherapy medication and embolization materials into the blood vessels that lead to the tumors. SBRT or SABR may be able to send radiation directly to the tumor and cause less damage to normal liver tissue. It is not yet known whether TACE is more effective than SBRT or SABR in treating patients with persistent or recurrent liver cancer who have undergone initial TACE.
Conditions
- Child-Pugh Class A
- Child-Pugh Class B
- Recurrent Hepatocellular Carcinoma
Interventions
- RADIATION
-
Stereotactic Body Radiation Therapy
Undergo SBRT
- PROCEDURE
-
Transarterial Chemoembolization
Undergo TACE
- DRUG
-
embolic agent
. Acceptable embolic agents include: * Gelatin sponge (gelfoam) * Polyvinyl alcohol (PVA) particles * Microspheres / Embolic beads
- DRUG
-
lipiodol
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Erqi Liu Pollom, MD · Stanford University
-
Daniel Chang, MD · Stanford University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-02-27
- Primary Completion
- 2022-12-31
- Completion
- 2022-12-31
Countries
- United States
- Japan
Study Locations
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