Drug-eluting Bead in Hepatocellular Carcinoma (REDEBUT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jin Wook Chung, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01332669
First received: February 6, 2011
Last updated: January 26, 2014
Last verified: January 2014
  Purpose

In unresectable hepatocellular carcinoma, TACE using Lipiodol/anti cancer agent emulsion is the standard treatment and reported as a significantly better treatment through randomized comparison study like Llovet, etc. than conservative treatment. Recently, doctors do transarterial chemoembolization with drug-eluting bead, and it is proved less side effect and better efficacy than conventional TACE using Lipiodol in Precision V study by Dr. Lammer, etc. But, it could not defined improved survival rate as expected. This study's purpose is evaluating treatment efficacy, survival rate and safety of TACE using drug eluting bead by comparing to conventional TACE using doxorubicin/Lipiodol emulsion for unresectable hepatocellular carcinoma.


Condition Intervention Phase
Hepatocellular Carcinoma
Procedure: DebDox TACE
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Registry of Chemoembolization Using Drug-eluting Bead in Patients With Unresectable Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • tumor response [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • survival rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Incidence rate and grade of side effect [ Time Frame: 6months ] [ Designated as safety issue: Yes ]
  • Time to progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Time to untreatable progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number of treatment required to achieve objective response [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2011
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: chemoembolization
HCC patients received chemoembolization
Procedure: DebDox TACE
HCC patients will receive chemoembolization (TACE) using DC beads containing Doxorubicin. The objective is to give 2 vials of DC Bead (2ml per vial) loaded with 70-75mg of Doxorubicin per vial (Each vial contain 2ml of DC Bead, thus doxorubicin concentration will be of 35-37.5mg per ml of DC Beads)
Other Names:
  • chemoembolization using drug eluting beads
  • DC bead chemoembolization
  • DebDox
  • TACE
Historical use of c-TACE using Lipiodiol and doxorubicin
The control arm will be of the patients that have been treated historically in the centers with conventional TACE (that is Lipiodiol plus doxorubicin).
Procedure: DebDox TACE
HCC patients will receive chemoembolization (TACE) using DC beads containing Doxorubicin. The objective is to give 2 vials of DC Bead (2ml per vial) loaded with 70-75mg of Doxorubicin per vial (Each vial contain 2ml of DC Bead, thus doxorubicin concentration will be of 35-37.5mg per ml of DC Beads)
Other Names:
  • chemoembolization using drug eluting beads
  • DC bead chemoembolization
  • DebDox
  • TACE

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with confirmed diagnosis of HCC as stated below

    • Cirrhotic subjects: Clinical diagnosis by AASLD criteria
    • Non-cirrhotic subjects: histological confirmation is mandatory
  2. Patient with HCC not suitable for radical therapies such as resection, liver transplantation or percutaneous therapies or patient is indicated for these therapies but there is a contraindication for them or patient himself rejects above treatments and wants to do TACE (Indication for hepatectomy, liver transplantation, local ablation is decided by doctors of each center)
  3. Multinodular or single nodular tumor over 5cm, (In the case of single nodule less than 5cm, if curative treatment is contraindicated or the patient rejects curative treatment)
  4. Hypervascular lesion showing contrast enhancement in the early stage at the contrast media bolus injection CT or MRI.
  5. At least one uni-dimensional lesion measurable according to the Modified RECIST criteria by CT-scan or MRI
  6. No invasion in the blood vessel (hepatic portal, hepatic vein) or bile duct by the CT or MR
  7. Eastern Cooperative Oncology Group performance status is 0 - 1
  8. Child-Pugh classification is A or B7
  9. Proper blood, liver, renal, heart function: testing result within 2 weeks from registry of this study is followed:

    • white blood cell number : > 3,000/mm2
    • platelet number : > 5 x 104/mm3
    • blood bilirubin : < 3.0 mg/dL
    • ASL, ALT is within 5 times of normal range of each organ
    • serum creatinine : < 1.5 mg/dL
    • hemoglobin : > 8.0 g/dL
  10. Over 20 years old
  11. Expected survival more than 6 months
  12. Patients who are willing to do regular visit, laboratory test, and radiological exam
  13. Prior written patient consent

Exclusion Criteria:

  1. ECOG performance status 2 or more, Child-Pugh class B8 or more
  2. Diffuse HCC or presence of vascular or biliary invasion or extrahepatic spread.
  3. Vascular or biliary invasion
  4. Extrahepatic metastasis (Any lymph nodes measuring ≥ 10mm along the short axis)
  5. Tumor burden involving more than 50% of the liver
  6. Patients previously treated with any anti-cancer therapy for HCC except hepatic resection or early recurrence within 1 year after resection
  7. Liver cancer rupture
  8. History of biliary tract repair or endoscopic biliary tract treatment
  9. Clinically important refractory ascites or pleural fluid
  10. Any contraindications for hepatic embolization procedures

    • Known hepatofugal blood flow
    • Arterio-venous shunt
    • Impaired clotting test (platelet count < 5 x 104/mm3, PT-INR > 2.0)
  11. Any contraindication for doxorubicin administration
  12. Contrast media allergy contraindicating angiography
  13. Acute or active following diseases

    • Heart failure can't control, angina pectoris and/or arrhythmia diseases
    • Myocardial infarction within the last 6months,
    • Renal failure
    • Active infection (virus infection can be accepted)
    • Active hemorrhage of digestive system
    • Other malignant tumor history
    • Hepatic coma or acute mental disease
  14. Pregnant, nursing or childbearing age women and men who are actively sexually available and don't want to or can't do contraception
  15. Safety concerns based on researcher's judge
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332669

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jin Wook Chung, MD Seoul National University Hospital
  More Information

Additional Information:
Publications:

Responsible Party: Jin Wook Chung, professor of radiology, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01332669     History of Changes
Other Study ID Numbers: Biocompatible-Korea
Study First Received: February 6, 2011
Last Updated: January 26, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
hepatocellular carcinoma
chemoembolization
drug eluting beads
HCC
Liver cancer
Korea

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 29, 2014