NCT02070419

TACE With or Without Radiation Therapy in Treating Patients With Stage A-C Liver Cancer

Trans-Arterial Chemo-Embolization (TACE) vs TACE Plus Stereotactic Body Radio Therapy (SBRT) in the Treatment of Hepatocellular Carcinoma (HCC)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well transarterial chemoembolization (TACE) works compared with TACE plus radiation therapy in treating patients with end stage liver disease, liver tumors, or potential liver transplant candidates. TACE involves reaching up to the blood vessel that feeds the tumor through a catheter placed into the groin vessel. Once the physician has defined the vessel going to the tumor, chemotherapy is infused to the tumor and the vessel is blocked, maintaining the chemotherapy for longer time inside the tumor and stopping the blood flow that feeds the tumor. Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that delivers radiation to the tumor cells but does not harm normal liver cells. It is not yet known whether TACE is more effective with or without SBRT in treating liver tumors.

Detailed description

PRIMARY OBJECTIVES: I. To determine in patients with stage A to C hepatocellular carcinoma, if stereotactic body radiotherapy after TACE enhanced the response rate of hepatocellular carcinoma (HCC) when compared to TACE alone at 3 months. SECONDARY OBJECTIVES: I. To determine in patients with stage A to C hepatocellular carcinoma, if TACE plus SBRT can achieve a downstaging rate of \>= 30% at 3 and 6 months. II. To determine the rate of grade 3 or 4 adverse events associated with SBRT for liver tumors. III. To determine the rate of local progression after SBRT. (Based on Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria) IV. Number of patients who achieve liver transplantation. V. Overall survival. OUTLINE: Patients are randomized to 1 of 2 treatment arms after the first loco-regional therapy with TACE. ARM I: Patients undergo TACE according to institutional standard with doxorubicin-eluting beads. ARM II: Patients undergo TACE as in Arm I and 3 or 5 fractions of SBRT given at least 48 hours apart over 14 days. After completion of study treatment, patients are followed up at 1, 3, and 6 months and then periodically thereafter.

Conditions

• Adult Primary Hepatocellular Carcinoma
• Recurrent Adult Primary Liver Cancer
• Stage I Adult Primary Liver Cancer
• Stage II Adult Primary Liver Cancer
• Stage IIIA Adult Primary Liver Cancer

Interventions

Type	Name	Description
PROCEDURE	transarterial chemoembolization	Undergo TACE with doxorubicin-eluting beads
RADIATION	stereotactic radiosurgery	Undergo SBRT

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2014-02-25
• Last updated: 2014-12-02