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Efficacy of Radiation Therapy and Transarterial Chemoembolization (TACE) to Treat Hepatocellular Carcinoma (HCC)

NCT01432314 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-06-26

No results posted yet for this study

Summary

In this study, the investigators are to prospectively evaluate patient's survival, tumor response, and safety of RT followed by TACE in Child A patients with unilobar portal vein invasion.

Conditions

Interventions

OTHER

Radiation therapy

A. Started 1 week after entry. B. Equipment: linear accelerator using 6-15 MV photons (external beam equipment). Computerized treatment planning system will be used to determine the radiation fields and 3D dose distribution. C. Target volume: include only the portal vein tumor thrombus and 2 cm margin into the contiguous HCC. Respiratory movement will be tracked (4D-CT). D. Dose: i) Dose for fraction: 3 Gy, at 5 fractions/week ii) Total dose: 45 Gy E. Criteria for stopping RT i) Development of grade 3 or 4 hepatotoxicity or gastrointestinal complications, as defined by CTCAE ver 4.0. Restart of RT should be within 2 weeks after stopping RT.

OTHER

Transarterial chemoembolization

A. Start at 2 weeks after completion of RT. B. TACE procedure: cisplatin 2 mg/kg infusion with 5-20 mL of lipiodol emulsion through the target artery of HCC. Gelfoam embolization will be used until to no tumor staining on re-angiography. C. At an interval of 8 weeks twice, and then every 3 months until contraindications or complete response develop.

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Han Chu Lee, M.D · Department of Internal Medicine, Asan Liver Center, Asan Medical Center, University of Ulsan College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-06-30
Completion
2014-06-30

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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 NCT01432314 on ClinicalTrials.gov