Comparison of SBRTand Repeat TACE for HCC (STH)

October 25, 2017 updated by: Gangneung Asan Hospital

Comparison of Stereotactic Body Radiation Therapy (SBRT)and Repeat Transarterial Chemoembolization (TACE) for Hepatocellular Carcinoma (HCC) as a Local Salvage Treatment After Incomplete TACE : A Prospective Randomized Trial

Comparison of Stereotactic Body Radiation Therapy (SBRT) and repeated transarterial chemoembolization (TACE) for Hepatocellular Carcinoma (HCC)as a Local Salvage Treatment after first incomplete TACE

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to evaluate the effect of SBRT after first incomplete TACE.

In HCC patients with incomplete TACE response, repeated TACE did not showed good response. In this case, SBRT could have better results than TACE.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gangwondo
      • Wŏnju, Gangwondo, Korea, Republic of, 25440
        • Recruiting
        • Gangneung Asan Hospital
        • Contact:
        • Contact:
          • Gan Jin Cheon, M.D Ph.D.
          • Phone Number: 82-33-610-3018
          • Email: 1000@gnah.co.kr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >18 years
  • Eastern cooperative oncology group(ECOG) score 0 to 2
  • Primary HCC
  • HCC (single nodule ≤ 7 cm or max 3 nodules ≤ 3 cm)
  • Child-Turgottei-Pugh A or B
  • Unresectable lesion or medically contraindicated surgery or a case in which surgery was declined.
  • No evidence of radiologically definable major vascular invasion or extrahepatic disease
  • Previously incomplete TACE with radiologically defined residual disease after first TACE
  • Informed consent

Exclusion Criteria:

  • Prior TACE to the target lesion
  • Contraindication to receiving radiotherapy or TACE
  • Decompensated liver cirrhosis
  • Extrahepatic mets
  • Pregnancy
  • Patients with other cancers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SBRT (Stereotatic body radiotherapy)
Treatment of SBRT in HCC patients who have incomplete response after first TACE
Radiation: SBRT
Maximum dose : 60Gray (Gy) Fraction : 2 to 5
Other Names:
  • Stereotactic Body Radiation Therapy
No Intervention: TACE (Transarterial chemoembolization)
Treatment of repeated TACE in HCC patients who have incomplete response after first TACE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local tumor control (efficacy fo SBRT)
Time Frame: 1 year

To evaluate the effect of SBRT. Local tumor control is defined as the disappearance of any intraarterial enhancement in all target lesions.

Local tumor control will be measured on triphasic Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI). Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free-survival
Time Frame: 2 year
survival from SBRT to recurrence
2 year
overall survival
Time Frame: 2 year
survival from SBRT to death
2 year
Radiation induced liver disease (RILD)
Time Frame: 1 year

Liver toxicities were evaluated using Common Terminology Criteria of Adverse Events (CTCAE).

RILD was defined as elevated liver transaminases more than five times the upper normal limit or a worsening of Child-Pugh (CP) score by 2 within 3 months after SBRT.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangneung Asan Hospital

Collaborators

Soonchunhyang University Hospital

Investigators

  • Study Director: Gab Jin Cheon, M.D, Ph. D, University of Ulsan College of Medicine, Gangneung Asan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

April 24, 2017

First Submitted That Met QC Criteria

October 25, 2017

First Posted (Actual)

October 31, 2017

Study Record Updates

Last Update Posted (Actual)

October 31, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GNH_RT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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