NCT02762266

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

International Randomized Study of Transarterial Chemoembolization (TACE) Versus Stereotactic Body Radiotherapy (SBRT) / Stereotactic Ablative Radiotherapy (SABR) for Residual or Recurrent Hepatocellular Carcinoma After Initial TACE

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the freedom from local progression (FFLP) of TACE versus (vs) SABR in patients with persistent hepatocellular carcinoma (HCC) after TACE. SECONDARY OBJECTIVES: I. To determine the progression-free survival (PFS) of TACE vs SABR in patients with persistent HCC after initial TACE. II. To determine the overall survival (OS) of TACE vs SABR for persistent HCC. III. To determine the toxicities associated with TACE or SABR for persistent HCC. OUTLINE: Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo TACE. ARM II: Beginning within 2 weeks of the radiation set-up scan and within 4 weeks of fiducial seed implantation (if applicable), patients undergo image guided SBRT 3 fractions within 1 week or 5 fractions within 2 weeks. After completion of study treatment, patients are followed up for 1-2 weeks, 1, 3, 6, 12, and 18 months, and every 6 months up to 3 years.

Conditions

• Child-Pugh Class A
• Child-Pugh Class B
• Recurrent Hepatocellular Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-02-27
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2016-05-04
• Last updated: 2024-03-12
• Results posted: 2024-03-12

Locations

2 sites across 2 countries: United States, Japan