UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011900
Receipt number R000013887
Scientific Title Randomized control study to investigate the effect of adjuvant transcatheter arterial infusion on prevention of early recurrence in patients after radical hepatectomy of hepatocellular carcinoma
Date of disclosure of the study information 2013/09/27
Last modified on 2013/09/27 01:37:23

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Basic information

Public title

Randomized control study to investigate the effect of adjuvant transcatheter arterial infusion on prevention of early recurrence in patients after radical hepatectomy of hepatocellular carcinoma

Acronym

Randomized control study to investigate the effect of adjuvant transcatheter arterial infusion on prevention of early recurrence in patients after radical hepatectomy of hepatocellular carcinoma

Scientific Title

Randomized control study to investigate the effect of adjuvant transcatheter arterial infusion on prevention of early recurrence in patients after radical hepatectomy of hepatocellular carcinoma

Scientific Title:Acronym

Randomized control study to investigate the effect of adjuvant transcatheter arterial infusion on prevention of early recurrence in patients after radical hepatectomy of hepatocellular carcinoma

Region

Japan


Condition

Condition

Hepatocellular carcinoma (HCC)

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of adjuvant transcatheter arterial infusion on prevention of early recurrence after radical hepatectomy of HCC

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Disease-free survival

Key secondary outcomes

Within 2 years recurrence
overall recurrence
overall survival


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Transcatheter arterial infusion of CDDP(50mg/m2) in 3 and 6 month after hepatectomy.

Interventions/Control_2

Best supprtive care

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

85 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Patients aged >= 20 years to < 80 years at informed consent and notified disease
(2) Child A or B
(3) Patients with an ECOG performance status(PS) of 0 or 1
(4) Written Informed consent must be obtained

Key exclusion criteria

(1) Child C
(2) Patients under dialysis therapy
(3) Any patients judged by the investigators to be unfit to participate in the study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhisa Uchiyama

Organization

Osaka Medical College

Division name

Department of General and Gastroenterological Surgery

Zip code


Address

2-7 Daigaku-machi, Takatsuki city Osaka 569-8686

TEL

072-683-1221

Email

sur122@poh.osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Fumitoshi Hirokawa

Organization

Osaka Medical College

Division name

Department of General and Gastroenterological Surgery

Zip code


Address

2-7 Daigaku-machi, Takatsuki city Osaka 569-8686

TEL

072-683-1221

Homepage URL


Email

sur122@poh.osaka-med.ac.jp


Sponsor or person

Institute

Department of General and Gastroenterological Surgery&#160;
Osaka Medical College

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


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

大阪医科大学附属病院(大阪府)


Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 27 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

Open public recruiting

Date of protocol fixation

2011 Year 08 Month 26 Day

Date of IRB


Anticipated trial start date

2011 Year 10 Month 01 Day

Last follow-up date

2016 Year 10 Month 01 Day

Date of closure to data entry

2017 Year 10 Month 01 Day

Date trial data considered complete

2017 Year 11 Month 01 Day

Date analysis concluded

2017 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2013 Year 09 Month 27 Day

Last modified on

2013 Year 09 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013887


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name