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

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 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


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

Value
https://center6.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