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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006822
Receipt No. R000008037
Scientific Title Phase I/II trial of cisplatin-based transarterial infusion and concomitant radiotherapy for advanced hepatocellular carcinoma with portal vein tumor thrombosis
Date of disclosure of the study information 2012/02/01
Last modified on 2019/06/10

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Basic information
Public title Phase I/II trial of cisplatin-based transarterial infusion and concomitant radiotherapy for advanced hepatocellular carcinoma with portal vein tumor thrombosis
Acronym Transarterial infusion and concomitant radiotherapy for hepatocellular carcinoma with portal vein tumor thrombosis
Scientific Title Phase I/II trial of cisplatin-based transarterial infusion and concomitant radiotherapy for advanced hepatocellular carcinoma with portal vein tumor thrombosis
Scientific Title:Acronym Transarterial infusion and concomitant radiotherapy for hepatocellular carcinoma with portal vein tumor thrombosis
Region
Japan

Condition
Condition Hepatocellular carcinoma with portal vein tumor thrombosis
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of cisplatin-based transarterial infusion and concomitant radiotherapy for advanced hepatocellular carcinoma with portal vein tumor thrombosis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) in Phase 1
PVTT response rate in Phase 2
Key secondary outcomes Adverse Event/Serious Adverse Event
Hepatic tumor response rate (overall tumor response rate)
Progression-free survival (PFS)
Overall survival (OS)
Change from baseline in hepatic functional reserve

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 Maneuver
Interventions/Control_1 Radiotherapy for portal vein tumor thrombus will be administered in fractions of 2.0 Gy/day, given 5 days per week for 25 days. The total dose of radiation will be 50 Gy.
Transarterial infusion of cisplatin is performed on Days 1, 8, 15, and 22, and concomitant intravenous bolus administration of sodium thiosulfate is used for systemic neutralization of cisplatin. In phase I, the initial dose of cisplatin is 30 mg/m2 (Level 1), given to 3 patients. The dose is increased in a stepwise fashion, and 3 other patients receive the next dose level until the Maximum Tolerated Dose (MTD) will be reached. In phase 2, the recommended dose (RD) of cisplatin is given to 24 patients.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Histologicaly or clinically confirmed as HCC
HCC with PVTT in main trunk or first brunch (Vp3, 4)
Child-Pugh score is less than 8.
Liver damage classification is A or B
ECOG performance status is 0 - 2.
Patients do not receive any local or systemic therapy for HCC within 4 weeks prior to the initiation of study treatment
Patients do not receive partial splenic embolization within 4 weeks prior to the initiation of study treatment
No disturbance of main organ functions ( including bone marrow, heart, lung, liver and kidney)
Leukocyte count: >=3,000/mm3
Platelet count: >=75,000/mm3
Hemoglobin concentration: >=8.0 g/dl
Serum AST and ALT: less than five times the upper limit of the normal at our hospital.
Total bilirubin concentration: <=3.0 mg/dl
Protrombin time: >=50 %
Serum creatinine concentration: <=1.2 mg/dl
Creatinine crearance:>= 45 ml/min
Key exclusion criteria Patients who have received platinum based anti cancer drug prior to the initiation of study treatment
extrahepatic metastasis
HCC with severe hepatic vein and biliary tumor thrombosis
Untreated esophageal and gastric varices with red color signs
stage II-IV encephalopathy
Allergic to a contrast media and platinum
Severe complications such as interstitial pneumonia, DM, heart failure, lung failure and liver failure
Active infection
Other cancers
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuya Okada
Organization Kobe University Hospital
Division name Department of Radiology
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-6104
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takuya Okada
Organization Kobe University Hospital
Division name Department of Radiology
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-6104
Homepage URL
Email

Sponsor
Institute kobe 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 神戸大学医学部附属病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 01 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
2012 Year 01 Month 31 Day
Date of IRB
2011 Year 12 Month 27 Day
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 12 Month 03 Day
Last modified on
2019 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008037

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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