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STH: Comparison of SBRTand Repeat TACE for HCC

Sponsor
Gangneung Asan Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03326375
Collaborator
Soonchunhyang University Hospital (Other)
80
Enrollment
1
Location
2
Arms
48
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: SBRT
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
open labled
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Mar 1, 2017
Anticipated Primary Completion Date :
Mar 1, 2020
Anticipated Study Completion Date :
Mar 1, 2021

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Local tumor control (efficacy fo SBRT) [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.

    Secondary Outcome Measures

    1. progression free-survival [2 year]

      survival from SBRT to recurrence

    2. overall survival [2 year]

      survival from SBRT to death

    3. Radiation induced liver disease (RILD) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gangneung Asan Hospital Wŏnju Gangwondo Korea, Republic of 25440

    Sponsors and Collaborators

    • Gangneung Asan Hospital
    • Soonchunhyang University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gangneung Asan Hospital
    ClinicalTrials.gov Identifier:
    NCT03326375
    Other Study ID Numbers:
    • GNH_RT-001
    First Posted:
    Oct 31, 2017
    Last Update Posted:
    Oct 31, 2017
    Last Verified:
    Oct 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gangneung Asan Hospital
    TACE
    SBRT
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of Oct 31, 2017