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A Phase 3 Trial Comparing TACE and TARE in Unilobar Advanced Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT02004210
Recruitment Status : Withdrawn (No participants were enrolled.)
First Posted : December 9, 2013
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
Jung-Hwan Yoon, Seoul National University Hospital

Brief Summary:
The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: transarterial radioembolization (TARE) Procedure: transarterial chemoembolization (TACE) Phase 3

Detailed Description:

Potentially curative treatments for hepatocellular carcinoma (HCC) include surgical resection, liver transplantation, and local ablative therapy.

However, HCC patients are diagnosed at advanced stages in Korea. Unresectable advanced HCCs are not suitable for other curative therapies. For these patients, the optimal treatment remains largely controversial. As a palliative treatment, the benefit of transarterial chemoembolization (TACE) had been shown in patients with unresectable HCC by several trials. Recently,transarterial radioembolization (TARE) has been introduced for the treatment of advanced HCC. However, the efficacy of TARE compared to TACE is uncertain.

The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-center, Open Label, Phase 3 Trial Comparing Conventional TACE and Transarterial Radioembolization in Patients With Unilobar Advanced Hepatocellular Carcinoma
Study Start Date : April 2013
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Arm Intervention/treatment
Experimental: The TARE group
transarterial radioembolization group
Procedure: transarterial radioembolization (TARE)
transarterial radioembolization

Experimental: The TACE group
Transarterial chemoembolization group
Procedure: transarterial chemoembolization (TACE)
transarterial chemoembolization




Primary Outcome Measures :
  1. Overall survival [ Time Frame: every 12 weeks, up to the time of death, up to 12 months ]
    From date of randomization until the date of death


Secondary Outcome Measures :
  1. Progression-Free Survival in the Liver [ Time Frame: every 12 weeks, up to the time of death or first documented intrahepatic tumor progression, up to 12 months ]
    From date of randomization until the date of first documented intrahepatic tumor progression or death

  2. Progression-Free Survival Overall [ Time Frame: every 12 weeks, up to the time of death or first documented progression, up to 12 months ]
    From date of randomization until the date of first documented progression or death

  3. Overall tumor response assessment [ Time Frame: every 12 weeks, up to the time of death or 12 months ]
    (CR, PR, SD, PD)by modified RECIST criteria



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC
  • Patients with advanced HCC with unilobar advanaced involvement: right lobe ± S4 segment or left lobe ± S4 segment)
  • Patients with single large HCC or multinodular HCC

    • Single & 5cm < size < 15cm
    • 2-5 nodules & maximal sized 4-15cm & sum of diameters ≦ 25cm
    • Infiltrative type & unilobular involvement on liver MRI
    • Segmental or lobar portal vein invasion can be included.
  • Age : 20 years to 80 years
  • ECOG Performance Status of 0 to 2
  • Child-Pugh class A (Child-Pugh score 5-6), B (CP score 7)
  • Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:

    • WBC count ≧ 1,000/mm3
    • Absolute neutrophil count > 500/mm3
    • Hb ≧ 7.0 g/dL
    • Platelet count > 100,000 /mm3
    • Bilirubin ≦ 3 mg/dL
    • Adequate clotting function: INR ≦ 2.3 or ≦ 6sec

Exclusion Criteria:

  • Child-Pugh score ≧ 8
  • ECOG Performance Status ≧ 3
  • Patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dL
  • History of organ allograft
  • Patients with uncontrolled co-morbidity which needs treatment
  • Patients who have received prior systemic chemotherapy
  • Patients who have received Capecitabine within 8 weeks
  • Patients with extrahepatic metastasis
  • Main portal vein invasion
  • Patients with lymph node metastasis
  • Bilobar involvement
  • Bulk disease(Tumor volume >70% of the target liver volume, or tumor nodules too numerous to count)
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004210


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jung-Hwan Yoon, M.D., Ph.D. Seoul National University Hospital

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Responsible Party: Jung-Hwan Yoon, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02004210     History of Changes
Other Study ID Numbers: TACE_TARE
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016

Keywords provided by Jung-Hwan Yoon, Seoul National University Hospital:
transarterial chemoembolization
transarterial radioembolization
advanced hepatocellular carcinoma

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases