- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00843934
Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma (ACE500)
October 17, 2012 updated by: Masashi Fujii, Nihon University
Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
450
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Masashi Fujii, MD
- Phone Number: +81332981711
- Email: masashi.fujii@gioncology.jp
Study Contact Backup
- Name: Tadatoshi Takayama, MD
- Phone Number: +81339728111
- Email: Takayama.Tadatoshi@nihon-u.ac.jp
Study Locations
-
-
Tokyo
-
Itabashi, Tokyo, Japan, 173-8610
- Recruiting
- Department of Digestive Surgery, Nihon University School of Medicine
-
Contact:
- Masashi Fujii, MD
- Phone Number: 207 +81332931711
- Email: masashi.fujii@gioncology.jp
-
Contact:
- Tadatoshi Takayama, MD
- Phone Number: 2471 +81339728111
- Email: Takayama.Tadatoshi@nihon-u.ac.jp
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- Serum Total Bilirubin 2.0mg/mL
- WBC 3000/mm3
- PLT 50000/mm3
- Hb 9.0g/dL
- Creatinine ; upper normal limit (UNL)
- 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)
- Severe heart disease
- Myocardial infarction within 6 months
- Renal insufficiency
- Active infections (except virous hepatitis)
- Gastrointestinal bleeding
- Active double cancer
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: anti-cancer agent
|
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 Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
response rate
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tadatoshi Takayama, M.D., Digestive Surgery Nihon University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Anticipated)
December 1, 2012
Study Completion (Anticipated)
February 1, 2015
Study Registration Dates
First Submitted
February 12, 2009
First Submitted That Met QC Criteria
February 12, 2009
First Posted (Estimate)
February 13, 2009
Study Record Updates
Last Update Posted (Estimate)
October 19, 2012
Last Update Submitted That Met QC Criteria
October 17, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Epirubicin
Other Study ID Numbers
- ACE500
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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