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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002427
Receipt No. R000002855
Scientific Title Evaluation of efficacy to combine radiofrequency ablation therapy and intrahepatic arterial infusion of DDP-H for hepatocellular carcinoma
Date of disclosure of the study information 2009/09/14
Last modified on 2017/04/01

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Basic information
Public title Evaluation of efficacy to combine radiofrequency ablation therapy and intrahepatic arterial infusion of DDP-H for hepatocellular carcinoma
Acronym Efficacy of RFA/hepatic arterial infusion of DDP-H combination in HCC
Scientific Title Evaluation of efficacy to combine radiofrequency ablation therapy and intrahepatic arterial infusion of DDP-H for hepatocellular carcinoma
Scientific Title:Acronym Efficacy of RFA/hepatic arterial infusion of DDP-H combination in HCC
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Cases with hepatocellular carcinoma (HCC), for which radiofrequency ablation therapy (RFA) is a proper therapeutic indication, are prospectively divided into two groups in random fashion; 1) RFA alone, and 2) RFA and intrahepatic arterial infusion of DDP-H. The efficacy of DDP-H is evaluated based on the time to development of intrahepatic metastasis and overall survival.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes 1) Primary endpoint, the time when a classical HCC is confirmed by several imaging modalities in the liver except for the vicinity to the RFA area.

2) Secondary endpoint, allover survival
Key secondary outcomes Tumor markers of AFP, DCP and other serum biochemistries.

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 NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Radiofrequency ablation therapy
Interventions/Control_2 Radiofrequency ablation therapy + intrahepatic arterial infusion of DDP-H
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
15 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) No residue of classical HCC after RFA
2) Japan integrated stage scores 2 or 3
3) Child-Pugh A or B
4) No active cancers except for HCC
5) Performance status (ECOG) 0, 1 or 2
6) Satisfying following serum biochemistries before therapy
WBC 3,000 /micro litter=<
Platelet 50,000 /micro litter=<
Hb 8.0 g/dl=<
Total bilirubin 3.0 g/dl=>
Creatinine clearance 50ml/min=< (after adjustment to 1.73m2 of body surface area)
7) No anti-cancer treatments affecting the liver except for the RFA target
8) Agreement to be enrolled in a form of informed consent
Key exclusion criteria 1) Severe allergic history for iodine and platinum drug
2) Pregnant, possibility of pregnancy, or feeding a baby
3) Vascular involvement Vp3, Vv3 or more
4) Under interferon therapy
5) Other factors that a responsible doctor judged to be unsuitable
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Suda
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Department of Gastroenterology & Hepatology
Zip code
Address 1-754 Asahi-machi, Chuo-ku, Niigata, Niigata 951-8122, Japan
TEL 025-223-6161
Email tspitt@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiko Ohsaki
Organization Niigata Hepatocellular Carcinoma Therapy Study Group
Division name Excutive office
Zip code
Address 1-757 Asahi-machi, Chuo-ku, Niigata, Niigata 951-8122, Japan
TEL 025-227-2207
Homepage URL
Email tm98020ao-nii@umin.ac.jp

Sponsor
Institute Niigata Hepatocellular Carcinoma Therapy Study Group
Institute
Department

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
2009 Year 09 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 Terminated
Date of protocol fixation
2009 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2014 Year 08 Month 01 Day
Date of closure to data entry
2015 Year 03 Month 01 Day
Date trial data considered complete
2015 Year 03 Month 01 Day
Date analysis concluded
2016 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 09 Month 01 Day
Last modified on
2017 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002855

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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