UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008581
Receipt number R000010081
Scientific Title Comparison between coagulations of RFA with sorafenib and standard RFA in patients with HCC.
Date of disclosure of the study information 2012/07/31
Last modified on 2014/08/04 15:58:39

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Basic information

Public title

Comparison between coagulations of RFA with sorafenib and standard RFA in patients with HCC.

Acronym

Comparison between coagulations of RFA with sorafenib and standard RFA in patients with HCC.

Scientific Title

Comparison between coagulations of RFA with sorafenib and standard RFA in patients with HCC.

Scientific Title:Acronym

Comparison between coagulations of RFA with sorafenib and standard RFA in patients with HCC.

Region

Japan


Condition

Condition

Hepatocellular carcinoma (HCC)

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We compare the coagulation diameters for RFA with Sorafenib and standard RFA on CT scans obtained 1 week after treatment.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

coagulation effect

Key secondary outcomes

(1)bebore,1 week after,4 weeks after,change of tumor marker
(2)blood flow changes before and after Sorafenib
(3)changes of liver function
(4)histological changes before and after Sorafenib


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Before RFA, Sorafenib 800mg /day x 7 days po

Interventions/Control_2


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)HCC patients admitted at this hospital and Child-Pugh Score<=9
2)Performance status:0-2
3)HCC diagnoed by image diagnosis or histology
4)patients with <=3 lesions of small and <=3 cm diameter
5)patients at the age of>=20 and <=80
6)patients who understand this study and sign an informed consent form at the time of enrollment.

Key exclusion criteria

1)T-Bil >=3.0mg/dl,PT <=50%
2)patients during pregnacy, lactation period, or who have a plan to be pregnant
3)patients with massive fluid
4)patient the doctor judged as a non-indication
5)patients with tumor thrombus in the main trunk of portal vein or bile duct
6)severe portal hypertention with treatment-resistant gastric or esophageal varices
7)treatment-resistant ascites
8)bleeding tendency(Plt <=50000/mm3)
9)patients with their prognosis <3 months
10)patient the doctor judged as a non-indication from the medical or mental status

Target sample size

170


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazushi Numata

Organization

Yokohama City University Medical Center

Division name

Gastroenterlogical Center

Zip code


Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hiroyuki Fukuda

Organization

Yokohama City University Medical Center

Division name

Gastroenterlogical Center

Zip code


Address

Yokohama City University Medical Center

TEL


Homepage URL


Email

fukuhiro@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University Medical Center

Institute

Department

Personal name



Funding Source

Organization

None

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

2012 Year 07 Month 31 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://dx.doi.org/10.1148/radiol.14131640

Number of participants that the trial has enrolled


Results

Sorafenib-RFA may be superior to standard RFA alone in the treatment of HCC tumors smaller than 3 cm in diameter.

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

Main results already published

Date of protocol fixation

2011 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 10 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 07 Month 31 Day

Last modified on

2014 Year 08 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010081


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name