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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003113
Receipt No. R000003238
Scientific Title Combination chemotherapy of hepatic arterial infusion chemotherapy with cisplatin and S-1in patients with advanced hepatocellular carcinoma: phase I trial
Date of disclosure of the study information 2010/02/01
Last modified on 2015/06/04

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Basic information
Public title Combination chemotherapy of hepatic arterial infusion chemotherapy with cisplatin and S-1in patients with advanced hepatocellular carcinoma: phase I trial
Acronym Phase I trial of CDDP-HAI+S-1 in advanced HCC
Scientific Title Combination chemotherapy of hepatic arterial infusion chemotherapy with cisplatin and S-1in patients with advanced hepatocellular carcinoma: phase I trial
Scientific Title:Acronym Phase I trial of CDDP-HAI+S-1 in advanced HCC
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of hepatic arterial infusion chemotherapy with cisplatin and S-1in patients with advanced hepatocellular carcinoma
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Dose limited toxicity
Key secondary outcomes Response rate
Progression free survival
Overall survival

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 Hepatic arterial injection of cisplatin (50-60mg/m2) conbined with S-1
The treatment is repeated every four weeks for a maximum of six courses if there is no evidence of tumor progression or unacceptable toxicity.
Level 0[50mg/m2,50-80mg/day]
Level 1[65, 50-80]
Level 2[65, 60-100]
Level 3[65, 80-120]
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Advanced hepatocellular carcinoma with confirmation of histological examination or typical computed tomographic, angiographic findings and elevated serum alpha-fetoprotein levels
2) No indication for surgical resection
3) No indication for sorafenib
4) Aged 20 years or over
5) An Eastern Cooperative Oncology Group performance status of 0-2
6) Measurable disease
7) Sufficient organ function: WBC>=3,000 /mm3, Hb>=9.0 g/dL, PLT>=50,000 /mm3, Child-Pugh grade A or B, T-Bil<=2.0 mg/dL, AST<=150 U/L, ALT<=150 U/L, Creatinine<=1.1 mg/dL
8) Interval of 4 weeks or over between last treatment and present therapy, and no influence of previous treatments
9) Written informed consent
Key exclusion criteria 1) Prior chemotherapy with cisplatin and fluorouracil for hepatocellular carcinoma
2) Prior radiotherapy, transcatheter arterial chemoembolization, and hepatic arterial chemotherapy for portal vein tumor thrombosis of hepatocellular carcinoma
3) Refractory pleural effusion or ascites
4) Distant metastases
5) Allergic reaction to iodine contrast material
6) Severe renal disease
7) Severe heart disease
8) Active infection excluding hepatitis B or C viral infection
9) Active concomitant malignancy
10) Severe mental disorder
11) Severe allergic reaction to drug
12) Pregnant and lactating females; females of childbearing age unless using effective contraception
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuji Okusaka
Organization National Cancer Center Hospital
Division name Medical Oncology
Zip code
Address 5-1-1, Tukiji, Chuoku, Tokyo
TEL 03-3542-2511
Email shkondo@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunsuke Kondo
Organization National Cancer Center Hospital
Division name Medical Oncology
Zip code
Address 5-1-1, Tukiji, Chuoku, Tokyo
TEL 03-3542-2511
Homepage URL
Email shkondo@ncc.go.jp

Sponsor
Institute National Cancer Center
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
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 国立がんセンター中央病院(東京都)
国立がんセンター東病院(千葉県)

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/24779747
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 Completed
Date of protocol fixation
2010 Year 01 Month 29 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2012 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 28 Day
Last modified on
2015 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003238

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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