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Hepatectomy With or Without Transcatheter Arterial Chemoembolization for Stage IIIA Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT00652587
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : April 3, 2008
Sponsor:
Collaborator:
Ministry of Health, China
Information provided by:
Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE March 31, 2008
First Posted Date  ICMJE April 3, 2008
Last Update Posted Date April 3, 2008
Study Start Date  ICMJE January 2002
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2008)
overall survival rates [ Time Frame: 1-, 3-, and 5-year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hepatectomy With or Without Transcatheter Arterial Chemoembolization for Stage IIIA Hepatocellular Carcinoma
Official Title  ICMJE A Randomized Controlled Trial of Hepatectomy With Adjuvant Transcatheter Arterial Chemoembolization Versus Hepatectomy Alone for Stage IIIA Hepatocellular Carcinoma
Brief Summary The purpose of this study is to evaluate whether hepatectomy combining with adjuvant transcatheter arterial chemoembolization (TACE) for Stage IIIA hepatocellular carcinoma (HCC) resulting better long-term survival outcome when compared with hepatectomy alone.
Detailed Description

Hepatocellular carcinoma (HCC) is one of the most common malignancies in the world, and the prevalence is increasing in the United States. Hepatectomy is still considered as the potentially curative treatment for HCC. Unfortunately, long-term survival after hepatectomy is still unsatisfactory because of the high incidence of tumor recurrence, especially intrahepatic recurrence.

Stage IIIA hepatocellular carcinoma (HCC) include multiple tumors more than 5 cm or tumor involving a major branch of the portal or hepatic vein(s) in the International Union Against Cancer (UICC) TNM staging for liver tumors, sixth edition 2002. Until now there are controversies in the management of Stage IIIA HCC. According to the Barcelona -Clinic-Liver-Cancer (BCLC) proposal, Stage IIIA HCC represented as intermediate or advanced disease. The European Association for Study of the Liver (EASL) and the American Association for the Study of Liver Diseases (AASLD) recommended randomized controlled trials of chemoembolization or new agents for such stage of disease. Whereas in Asian areas, such as China or Japan, partial hepatectomy or reductive surgery (with or without adjuvant therapy) was performed for multiple advanced HCC or tumor with a major branch of the portal or hepatic vein(s) invasion, although no prospective study to assess the therapeutic efficacy and safety. On the other hand, transcatheter arterial chemoembolization (TACE) is the most widely used primary treatment for unresectable HCC. It was also used as the optional treatment of relapsed disease. However, the efficacy of TACE used as adjuvant therapy following hepatectomy remains controversial. Neither are there large randomized controlled trials to address this field. Therefore, a randomized controlled trial was performed in our cancer center to compare hepatectomy with adjuvant TACE and hepatectomy alone for the Stage IIIA HCC.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatocellular Carcinoma
  • Hepatectomy
  • Chemoembolization
Intervention  ICMJE
  • Procedure: hepatectomy and transcatheter arterial chemoembolization
    partial hepatectomy with adjuvant transcatheter arterial chemoembolization
  • Procedure: hepatectomy
    hepatectomy alone
    Other Name: hepatectomy alone
Study Arms  ICMJE
  • Experimental: A, LRTACE
    hepatectomy with adjuvant transcatheter arterial chemoembolization
    Intervention: Procedure: hepatectomy and transcatheter arterial chemoembolization
  • Active Comparator: B, LR
    hepatectomy alone
    Intervention: Procedure: hepatectomy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2008)
115
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female patients > 18 years and <=70 years of age
  • Patients who have an ECOG PS of 0 or 1.
  • a preoperative diagnosis of HCC with no previous treatment;
  • compensated cirrhosis with Child-Pugh class A, B or no cirrhosis;
  • multiple tumors more than 5 cm or tumor involving a major branch of the portal or hepatic vein(s) on preoperative investigations, and on intraoperative ultrasound and gross examination of the liver during the surgery;
  • on exploration and intraoperative ultrasound the tumor could safely be resected without grossly remaining tumors, and the patient was judged to have adequate liver functional reserve to survive the operation.

Exclusion Criteria:

  • Patient compliance is poor
  • Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted.
  • History of cardiac disease:

    • congestive heart failure > New York Heart Association (NYHA) class 2;
    • active coronary artery disease (myocardial infarction more than 6 months prior to study entry is permitted);
    • cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers, calcium channel blocker or digoxin; or
    • uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of 3 antihypertensive drugs).
  • Active clinically serious infections (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
  • Known history of human immunodeficiency virus (HIV) infection
  • Known Central Nervous System tumors including metastatic brain disease
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
  • Distantly extrahepatic metastasis
  • History of organ allograft
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Known or suspected allergy to the investigational agent or any agent given in association with this trial
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
  • Excluded therapies and medications, previous and concomitant:

    • Prior use of any systemic anti-cancer treatment for HCC, eg. chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior randomization.
    • Prior use of systemic investigational agents for HCC
    • Autologous bone marrow transplant or stem cell rescue within four months of start of study drug
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00652587
Other Study ID Numbers  ICMJE HCC_001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cancer Center, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Ministry of Health, China
Investigators  ICMJE
Principal Investigator: GUO Rong-ping, MD Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP