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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007267
Receipt No. R000008575
Scientific Title Randomized controlled study to examine the efficacy of hepatic arterial infusion chemotherapy with cisplatin before radiofrequency ablation for hepatocellular carcinoma
Date of disclosure of the study information 2012/02/11
Last modified on 2016/08/16

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Basic information
Public title Randomized controlled study to examine the efficacy of hepatic arterial infusion chemotherapy with cisplatin before radiofrequency ablation for hepatocellular carcinoma
Acronym Efficacy of HAIC with cisplatin before RFA for HCC
Scientific Title Randomized controlled study to examine the efficacy of hepatic arterial infusion chemotherapy with cisplatin before radiofrequency ablation for hepatocellular carcinoma
Scientific Title:Acronym Efficacy of HAIC with cisplatin before RFA for HCC
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of hepatic arterial infusion chemotherapy with cisplatin before RFA for the prevention of HCC recurrence
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Recurrence free survival
Key secondary outcomes Incidence of adverse events
Time to treatment failure with RFA
Evaluation of treatment effect with tumor markers

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Hepatic arterial infusion chemotherapy with cisplatin and RFA
Interventions/Control_2 RFA
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients with hepatocellular carcinoma diagnosed by histologial examination or by imaging modalities
2) Less than or equal to 3 lesions, 30 mm or less in diameter
3) No extra-hepatic metastasis
4) No vascular invasion
5) Patients in Child-Pugh Class A or B
6) Male or female aged 20 years or older at the time of informed consent and younger than 90 years old
7) Patients with an ECOG Performance Status (PS) score of 0 or 1
8) No prior chemotherapy
9) Adequate organ function
a) Neutrophil>=1500 /mm3
b) Hb>= 8.5 g/dL
c) PLT>= 50000 /mm3
d) T-Bil<= 2.0 mg/dL
e) AST<= within 5 times of normal limit
ALT<= within 5 times of normal limit
f) Cre<= within 1.5 times of normal limit
10) Written informed consent
11) Life expectancy of at least 6 months
Key exclusion criteria 1) Patients with histologically diagnosed mixed hepatocellular carcinoma or sarcomatoid carcinoma
2) History of any therapy to hepatocellular carcinoma
3) Patients unsuitable for RFA
4) Patients unsuitable for administration of CDDP
5) Patients who have simultaneous malignancies
6) Patients who have severe complications
7) Ascites or pleural effusion unresponsible to therapy
8) Patients inadequate in the investigator's judgement
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhide Yamamoto
Organization Okayama university graduate school of medicine, dentistry, and pharmaceutical sciences
Division name Department of gastroenterology and hepatology
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama prefecture
TEL 090-235-7219
Email kazuhide@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Nouso
Organization Okayama university hospital
Division name Department of gastroenterology
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama prefecture
TEL 086-235-7219
Homepage URL
Email nouso@cc.okayama-u.ac.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 02 Month 11 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
2012 Year 01 Month 24 Day
Date of IRB
Anticipated trial start date
2012 Year 03 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 02 Month 11 Day
Last modified on
2016 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008575

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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