UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000111 |
|---|---|
| Receipt number | 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 19:47:50 |
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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
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
Sponsor or person
Institute
Research group for randomised study comparing transcatheter arterial chemoembolization to transarterial infusion chemotherapy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000163
