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SBRT + TACE for Primary Hepatocellular Carcinoma

NCT00746655 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-12-24

No results posted yet for this study

Summary

The purpose of this study is to determine the feasibility and toxicity of combining SBRT and TACE for unresectable HCC and to evaluate the Health Related Quality of Life (HRQL) associated with combined therapy.

Conditions

Interventions

RADIATION

Stereotactic Body Radiation Therapy (SBRT)

The first four patients will receive 50 Gy in 5 fractions (10 Gy /fx) over a 2 week period. The next four patients will be treated to a total dose of 60 Gy in 5 fractions (15 Gy/fx) over two weeks. The final four patients will receive 75 Gy in 5 fractions (15 Gy/fx) delivered over a 2-week period,

PROCEDURE

Transcatheter Arterial Chemoembolization (TACE)

. Intra-arterial cisplatin treatment will be given at a dose of 125 mg/m2. After delivery of the drug(s) to the tumor, embolization will be accomplished with Embospheres (Biosphere Medical, Inc.,Rockland, MA, USA) until moderate to marked stasis of antegrade flow is seen in the artery.

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Dwight E Heron, MD · University of Pittsburgh Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00746655 on ClinicalTrials.gov