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Chemoembolization With or Without Stereotactic Body Radiosurgery for Liver Cancer

NCT02304445 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-11-26

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Juan Sanabria, MD

    lead OTHER

Principal Investigators

  • Juan Sanabria, MD · Midwestern Reginal Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-11-30
Completion
2017-11-30

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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 NCT02304445 on ClinicalTrials.gov