Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma (ACE500)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Nihon University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Nihon University
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
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Hepatocellular |
Drug: epirubicin Drug: Cisplatin |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma |
Resource links provided by NLM:
Further study details as provided by Nihon University:
Primary Outcome Measures:
- response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 450 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: anti-cancer agent |
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
|
Eligibility| Ages Eligible for Study: | 20 Years to 79 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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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: NCT00843934
Please refer to this study by its ClinicalTrials.gov identifier: NCT00843934
Contacts
| Contact: Masashi Fujii, MD | +81332981711 | masashi.fujii@gioncology.jp | |
| Contact: Tadatoshi Takayama, MD | +81339728111 | Takayama.Tadatoshi@nihon-u.ac.jp |
Locations
| Japan | |
| Department of Digestive Surgery, Nihon University School of Medicine | Recruiting |
| Itabashi, Tokyo, Japan, 173-8610 | |
| Contact: Masashi Fujii, MD +81332931711 ext 207 masashi.fujii@gioncology.jp | |
| Contact: Tadatoshi Takayama, MD +81339728111 ext 2471 Takayama.Tadatoshi@nihon-u.ac.jp | |
Sponsors and Collaborators
Nihon University
Investigators
| Principal Investigator: | Tadatoshi Takayama, M.D. | Digestive Surgery Nihon University School of Medicine |
More Information
| Responsible Party: | Masashi Fujii, Professor, Nihon University |
| ClinicalTrials.gov Identifier: | NCT00843934 History of Changes |
| Other Study ID Numbers: | ACE500 |
| Study First Received: | February 12, 2009 |
| Last Updated: | October 17, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Nihon University:
|
Carcinoma, Hepatocellular Trans arterial chemoembolization Epirubicin Cisplatin |
Additional relevant MeSH terms:
|
Carcinoma, Hepatocellular Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases |
Liver Diseases Cisplatin Epirubicin Antineoplastic Agents Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 26, 2016