UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003113 |
|---|---|
| Receipt number | 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 11:13:32 |
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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
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
shkondo@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003238
