UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002428 |
|---|---|
| Receipt number | R000002856 |
| Scientific Title | Evaluation of efficacy to combine transarterial chemoembolization and intrahepatic arterial infusion of DDP-H for hepatocellular carcinoma |
| Date of disclosure of the study information | 2009/09/14 |
| Last modified on | 2010/11/11 00:04:23 |
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Basic information
Public title
Evaluation of efficacy to combine transarterial chemoembolization and intrahepatic arterial infusion of DDP-H for hepatocellular carcinoma
Acronym
Efficacy of TACE/hepatic arterial infusion of DDP-H combination in HCC
Scientific Title
Evaluation of efficacy to combine transarterial chemoembolization and intrahepatic arterial infusion of DDP-H for hepatocellular carcinoma
Scientific Title:Acronym
Efficacy of TACE/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 transarterial chemoembolization (TACE) is a proper therapeutic indication, are prospectively divided into two groups in random fashion; 1) TACE alone, and 2) TACE and intrahepatic arterial infusion of DDP-H. The efficacy of DDP-H is evaluated based on response rate of TACE, 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 TACE 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
TACE alone
Interventions/Control_2
TACE + 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) A proper indication for TACE according to Japan HCC management guideline
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
160
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
025-227-2207
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
tm98020ao-nii@umin.ac.jp
Sponsor or person
Institute
Niigata Hepatocellular Carcinoma Therapy Study Group
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
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
| 2013 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 01 | Day |
Last modified on
| 2010 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002856
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