Unique ID issued by UMIN | UMIN000001384 |
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Receipt number | R000001678 |
Scientific Title | Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma |
Date of disclosure of the study information | 2008/10/14 |
Last modified on | 2014/06/09 17:48:47 |
Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma
ACE 500 Study
Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma
ACE 500 Study
Japan |
Hepatocellular Carcinoma
Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Malignancy
NO
To compare the efficacy and safety of CDDP and EPI in the treatment of transcatheter chemoembolization for HCC.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II,III
P-II part: Response Rate
P-III part: Overall survival
P-II part: Adverse events
P-III part: Time to treatment failure, response rate, adverse events
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
YES
Central registration
2
Treatment
Medicine |
Suspension is prepared before arterial infusion as follows: Epirubicin is dissolved with water-soluble, non-ionized contrast medium then mixed with Lipiodol by pomping. 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.
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.
20 | years-old | <= |
80 | years-old | > |
Male and Female
1. Subject must be histologically or clinically proven HCC, inoperable, no indication of local treatment and has mesurable lesions.
2. Subject must to be the first experience of TACE.
3. Subject has no extra-hepatic tumor and no obstruction of main portal vein.
4. Subjects must have fully recovered from previous treatment (at least 4 weeks interval is needed from prior chmotherapy or radiation therapy).
5. ECOG performance status 0-2
6. Child-pugh Class A or B
7. Subject must have adequate functions of bonemarrow, renal, circuratory 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
8. Written informed consent
1. Subject has extra hepatic metastasis.
2. Tumor thrombosis exists at main portal vein.
3. Remarkable artery-portal vein shunt or veno-arterial shunt.
4. Uncontrollable ascites or pleural effusion.
5. History of severe hypersensitivity.
6. Any previous TACE or TAE for HCC.
7. Any previous chemotherapy using epirubicin or CDDP.
8. 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.
9.Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant.
10. Any subject judged by the investigator to be unfit for any reason to participate in the study.
450
1st name | |
Middle name | |
Last name | Tadatoshi Takayama |
Nihon University School of Medicine
Devision of Digestive Surgery
30-1, Oyaguchi-kamimachi, Itabashi, Tokyo
03-3972-8111
takayama.tadatoshi@nihon-u.ac.jp
1st name | |
Middle name | |
Last name | Masamichi Moriguchi |
Nihon University School of Medicine
Devision of Digestive Surgery
30-1, Oyaguchi-kamimachi, Itabashi, Tokyo 173-8610
03-3972-8111
moriguchi.masamichi@nihon-u.ac.jp
ACE 500 Study Group
Nihon University School of Medicine
Self funding
Japan
NO
2008 | Year | 10 | Month | 14 | Day |
Unpublished
No longer recruiting
2008 | Year | 03 | Month | 21 | Day |
2008 | Year | 09 | Month | 01 | Day |
2012 | Year | 12 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
2016 | Year | 12 | Month | 01 | Day |
2008 | Year | 09 | Month | 19 | Day |
2014 | Year | 06 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001678
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