UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001384
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

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Basic information

Public title

Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

Acronym

ACE 500 Study

Scientific Title

Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

Scientific Title:Acronym

ACE 500 Study

Region

Japan


Condition

Condition

Hepatocellular Carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy and safety of CDDP and EPI in the treatment of transcatheter chemoembolization for HCC.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II,III


Assessment

Primary outcomes

P-II part: Response Rate
P-III part: Overall survival

Key secondary outcomes

P-II part: Adverse events
P-III part: Time to treatment failure, response rate, adverse events


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

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.

Interventions/Control_2

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.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

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

Key exclusion criteria

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.





Target sample size

450


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tadatoshi Takayama

Organization

Nihon University School of Medicine

Division name

Devision of Digestive Surgery

Zip code


Address

30-1, Oyaguchi-kamimachi, Itabashi, Tokyo

TEL

03-3972-8111

Email

takayama.tadatoshi@nihon-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masamichi Moriguchi

Organization

Nihon University School of Medicine

Division name

Devision of Digestive Surgery

Zip code


Address

30-1, Oyaguchi-kamimachi, Itabashi, Tokyo 173-8610

TEL

03-3972-8111

Homepage URL


Email

moriguchi.masamichi@nihon-u.ac.jp


Sponsor or person

Institute

ACE 500 Study Group

Institute

Department

Personal name



Funding Source

Organization

Nihon University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2008 Year 10 Month 14 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2008 Year 03 Month 21 Day

Date of IRB


Anticipated trial start date

2008 Year 09 Month 01 Day

Last follow-up date

2012 Year 12 Month 01 Day

Date of closure to data entry

2015 Year 12 Month 01 Day

Date trial data considered complete

2015 Year 12 Month 01 Day

Date analysis concluded

2016 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 09 Month 19 Day

Last modified on

2014 Year 06 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001678


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name