UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006822 |
|---|---|
| Receipt number | 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 11:42:25 |
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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
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
Sponsor or person
Institute
kobe University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008037
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