Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma (ACE500)

This study is currently recruiting participants.

Verified October 2012 by Nihon University

Sponsor:

Information provided by (Responsible Party):

Masashi Fujii, Nihon University

ClinicalTrials.gov Identifier:

NCT00843934

First received: February 12, 2009

Last updated: October 17, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 12, 2009

Last Updated Date

October 17, 2012

Start Date ^ICMJE

March 2009

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00843934 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

Official Title ^ICMJE

Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

Brief Summary

The purpose of this study is to compare the efficacy and safety of cisplatin (CDDP) and epirubicin (EPI) in the treatment of transcatheter chemoembolization for Hepatocellular Carcinoma (HCC).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Carcinoma, Hepatocellular

Intervention ^ICMJE

Drug: epirubicin
Arm E: Suspension is prepared before arterial infusion as follows: Epirubicin is dissolved with water-soluble, non-ionized contrast medium then mixed with Lipiodol by pumping. Then this suspension is administered by catheter as quick as possible, and gelatin is infused for arterial embolization. Maximum dose of EPI and Lipiodol are 60mg/m2 and 0.3mL/Kg, respectively.

Other Name: epi-adriamycin
Drug: Cisplatin
Arm C: Suspension is prepared before arterial infusion as follows: Cisplatin (Water soluble CDDP: IA CALL) is mixed with Lipiodol. Then this suspension is administered by catheter as quick as possible, and gelatin is infused for arterial embolization. Maximum dose of Cisplatin and Lipiodol are 65mg/m2 and 0.3mL/Kg, respectively.

Other Name: CDDP

Study Arm (s)

Experimental: anti-cancer agent

Interventions:

Drug: epirubicin
Drug: Cisplatin

Publications *

Not Provided

* 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

Recruiting

Estimated Enrollment ^ICMJE

450

Estimated Completion Date

February 2015

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subject must be histologically or clinically proven HCC, inoperable, no indication of local treatment and has measurable lesions.
Subject must to be the first experience of TACE.
Subject has no extra-hepatic tumor and no obstruction of main portal vein.
Subjects must have fully recovered from previous treatment (at least 4 weeks interval is needed from prior chmotherapy or radiation therapy).
ECOG performance status 0-2
Child-pugh Class A or B
Subject must have adequate functions of bonemarrow, renal, circulatory organs and appropriate examination results as below:
1. Serum Total Bilirubin 2.0mg/mL
2. WBC 3000/mm3
3. PLT 50000/mm3
4. Hb 9.0g/dL
5. Creatinine ; upper normal limit (UNL)
6. BUN 25mg/dL
Written informed consent

Exclusion Criteria:

Subject has extra hepatic metastasis.
Tumor thrombosis exists at main portal vein.
Remarkable artery-portal vein shunt or veno-arterial shunt.
Uncontrollable ascites or pleural effusion.
History of severe hypersensitivity.
Any previous TACE or TAE for HCC.
Any previous chemotherapy using epirubicin or CDDP.
Complications as below (except chronic hepatitis or liver cirrhosis)
1. Severe heart disease
2. Myocardial infarction within 6 months
3. Renal insufficiency
4. Active infections (except virous hepatitis)
5. Gastrointestinal bleeding
6. Active double cancer
7. Hepatic encephalopathy or heavy mental disorder.
Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant.
Any subject judged by the investigator to be unfit for any reason to participate in the study.

Gender

Both

Ages

20 Years to 79 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Masashi Fujii, MD	+81332981711	masashi.fujii@gioncology.jp
Contact: Tadatoshi Takayama, MD	+81339728111	Takayama.Tadatoshi@nihon-u.ac.jp

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00843934

Other Study ID Numbers ^ICMJE

ACE500

Has Data Monitoring Committee

Yes

Responsible Party

Masashi Fujii, Nihon University

Study Sponsor ^ICMJE

Nihon University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Tadatoshi Takayama, M.D.

Digestive Surgery Nihon University School of Medicine

Information Provided By

Nihon University

Verification Date

October 2012

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

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