NCT02304445

Chemoembolization With or Without Stereotactic Body Radiosurgery for Liver Cancer

Trans-Arterial Chemo-Embolization (TACE) Vs. TACE Plus Stereotactic Body Radiosurgery (SBRT) in the Treatment of Hepatocellular Carcinoma (HCC)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Juan Sanabria, MD · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, active comparator-controlled trial of subjects with advanced (Barcelona stage B/C) hepatocellular carcinoma. Subjects will be receive one treatment with Trans-Arterial Chemo-Embolization (TACE) prior to randomization. Subsequently, subjects will be randomized to observation or, if indicated, up to an additional TACE treatments, or to Stereotactic Body Radiotherapy (SBRT). Tumor response following interventions will be evaluated at three months.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
PROCEDURE	Transarterial Chemoembolization (TACE)	TACE is a treatment modality where local delivery of an anti-neoplastic agent is performed through the feeding artery of the tumor followed by end embolization of the artery. The goal of TACE is to cause tumor necrosis and tumor control via acute arterial occlusion while preserving as much functional liver tissue as possible.
RADIATION	TACE+Stereotactic Body Radiotherapy	This intervention adds Stereotactic Body Radiation (SBRT) to TACE therapy. SBRT is the precise administration of large doses of radiotherapy delivered over 1-5 treatments to extra-cranial tumors.

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2014-12-02
• Last updated: 2015-11-26