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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000111
Receipt No. R000000163
Scientific Title Transarterial infusion chemotherapy using SMANCS with or without embolization in hepatocellular carcinoma: a randomised controlled multicenter phase III trial
Date of disclosure of the study information 2005/09/04
Last modified on 2008/12/08

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Basic information
Public title Transarterial infusion chemotherapy using SMANCS with or without embolization in hepatocellular carcinoma: a randomised controlled multicenter phase III trial
Acronym Transarterial infusion chemotherapy with or without embolization in hepatocellular carcinoma
Scientific Title Transarterial infusion chemotherapy using SMANCS with or without embolization in hepatocellular carcinoma: a randomised controlled multicenter phase III trial
Scientific Title:Acronym Transarterial infusion chemotherapy with or without embolization in hepatocellular carcinoma
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We aimed to assess whether SMANCS with embolization could improve overall survival compared with SMANCS alone.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes survival
Key secondary outcomes

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
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 transcatheter arterial chemoembolization
Interventions/Control_2 Transarterial infusion chemotherapy
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
75 years-old >
Gender Male and Female
Key inclusion criteria Patients with unresectable hepatocellular carcinoma are eligible if they had no indication for resection or local ablation therapy. Diagnosis is confirmed histologically and/or clinically by angiography and computed tomography. Each patient is required to meet the following criteria: no prior therapy for hepatocellular carcinoma, tumor volume less than 50% of the entire liver, Nodular type in Eggel's classification, adequate hematological function (white blood cells >= 3000/mm3, platelets >= 50000/mm3, hemoglobin >= 9.0 g/dl), adequate hepatic function (serum total bilirubin =< 2.0 mg/dl, serum albumin >= 3.0 g/dl, serum AST =< five times the upper limit of normal value, serum ALT =< five times the upper limit of normal value), adequate renal function (BUN =< the upper limit of normal value, serum creatinine =< the upper limit of normal value), ECOG performance status of 0-1, at least one measurable intrahepatic lesion that showed tumor staining by angiography, and written informed consent.
Key exclusion criteria Patients were excluded if they met the following criteria: extrahepatic metastasis or tumor thrombus in the portal vein and/or the hepatic vein, refractory pleural or peritoneal effusion, a history of allergy to iodine-containing agent and/or contrast material, a history of acute myocardial infarction in preceding 3 months, serious mental disorder, concomitant malignancy, pregnant or lactating women and patients of reproductive potential, intrahepatic arteriovenous shunting, or other serious medical conditions.
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuji Okusaka
Organization National Cancer Center Hospital
Division name Hepatobiliary and Pancreatic Oncology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL 03-3542-2511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takuji Okusaka
Organization National Cancer Center Hospital
Division name Hepatobiliary and Pancreatic Oncology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL 03-3542-2511
Homepage URL
Email

Sponsor
Institute Research group for randomised study comparing transcatheter arterial chemoembolization to transarterial infusion chemotherapy
Institute
Department

Funding Source
Organization the Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 04 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 Completed
Date of protocol fixation
1999 Year 08 Month 09 Day
Date of IRB
Anticipated trial start date
1999 Year 10 Month 01 Day
Last follow-up date
2005 Year 06 Month 01 Day
Date of closure to data entry
2006 Year 03 Month 01 Day
Date trial data considered complete
2006 Year 05 Month 01 Day
Date analysis concluded
2006 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 04 Day
Last modified on
2008 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000163

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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